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Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline

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The aim was to formulate practice guidelines for determining settings where patients are most likely to benefit from the use of continuous glucose monitoring (CGM). The Endocrine Society appointed a Task Force of experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of The Endocrine Society, the Diabetes Technology Society, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. The Task Force evaluated three potential uses of CGM: 1) real-time CGM in adult hospital settings; 2) real-time CGM in children and adolescent outpatients; and 3) real-time CGM in adult outpatients. The Task Force used the best available data to develop evidence-based recommendations about where CGM can be beneficial in maintaining target levels of glycemia and limiting the risk of hypoglycemia. Both strength of recommendations and quality of evidence were accounted for in the guidelines.
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Continuous Glucose Monitoring: An Endocrine
Society Clinical Practice Guideline
David C. Klonoff, Bruce Buckingham, Jens S. Christiansen, Victor M. Montori,
William V. Tamborlane, Robert A. Vigersky, and Howard Wolpert
Mills-Peninsula Health Services (D.C.K.), San Mateo, California 94401; Stanford University School of
Medicine (B.B.), Stanford, California 94305; Aarhus University Hospital (J.S.C.), 8000 Aarhus C,
Denmark; Mayo Clinic (V.M.M.), Rochester, Minnesota 55905; Yale University School of Medicine
(W.V.T.), New Haven, Connecticut 06510; Walter Reed National Military Medical Center (R.A.V.),
Bethesda, Maryland 20889; and Joslin Diabetes Center (H.W.), Boston, Massachusetts 02215
Objective: The aim was to formulate practice guidelines for determining settings where patients
are most likely to benefit from the use of continuous glucose monitoring (CGM).
Participants: The Endocrine Society appointed a Task Force of experts, a methodologist, and a
medical writer.
Evidence: This evidence-based guideline was developed using the Grading of Recommendations,
Assessment, Development, and Evaluation (GRADE) system to describe both the strength of rec-
ommendations and the quality of evidence.
Consensus Process: One group meeting, several conference calls, and e-mail communications
enabled consensus. Committees and members of The Endocrine Society, the Diabetes Technology
Society, and the European Society of Endocrinology reviewed and commented on preliminary
drafts of these guidelines.
Conclusions: The Task Force evaluated three potential uses of CGM: 1) real-time CGM in adult
hospital settings; 2) real-time CGM in children and adolescent outpatients; and 3) real-time CGM
in adult outpatients. The Task Force used the best available data to develop evidence-based rec-
ommendations about where CGM can be beneficial in maintaining target levels of glycemia and
limiting the risk of hypoglycemia. Both strength of recommendations and quality of evidence were
accounted for in the guidelines. (J Clin Endocrinol Metab 96: 2968–2979, 2011)
Summary of Recommendations
1.0 Real-time continuous glucose monitoring
(RT-CGM) in adult hospital settings
1.1 We recommend against the use of RT-CGM alone for
glucose management in the intensive care unit (ICU) or op-
erating room until further studies provide sufficient evidence
for its accuracy and safety in those settings (1|QEEE).
2.0 RT-CGM in children and adolescent outpatients
2.1 We recommend that RT-CGM with currently ap-
proved devices be used by children and adolescents with
type 1 diabetes mellitus (T1DM) who have achieved
glycosylated hemoglobin (HbA1c) levels below 7.0%
because it will assist in maintaining target HbA1c levels
while limiting the risk of hypoglycemia (1|QQQQ).
2.2 We recommend RT-CGM devices be used with chil-
dren and adolescents with T1DM who have HbA1c lev-
els 7.0% who are able to use these devices on a nearly
daily basis (1|QQQE).
2.3 We make no recommendations for or against the
use of RT-CGM by children with T1DM who are less than
8 yr of age.
2.4 We suggest that treatment guidelines be provided to
patients to allow them to safely and effectively take ad-
vantage of the information provided to them by RT-CGM
(2|QEEE).
ISSN Print 0021-972X ISSN Online 1945-7197
Printed in U.S.A.
Copyright © 2011 by The Endocrine Society
doi: 10.1210/jc.2010-2756 Received November 22, 2010. Accepted June 17, 2011.
Abbreviations: CGM, Continuous glucose monitoring; CIT, conventional insulin therapy; HbA1c,
glycosylated hemoglobin; ICU, intensive care unit; IIT, intensive insulin therapy; ISF, interstitial fluid;
MDI, multiple daily injections; MICU, medical ICU; POC, point-of-care; RT-CGM, real-time CGM;
SMBG, self-monitoring of blood glucose; T1DM, type 1 diabetes mellitus.
SPECIAL FEATURE
Clinical Practice Guideline
2968 jcem.endojournals.org J Clin Endocrinol Metab, October 2011, 96(10):2968–2979
2.5 We suggest the intermittent use of CGM systems
designed for short-term retrospective analysis in pediatric
patients with diabetes in whom clinicians worry about
nocturnal hypoglycemia, dawn phenomenon, and post-
prandial hyperglycemia; in patients with hypoglycemic
unawareness; and in patients experimenting with impor-
tant changes to their diabetes regimen [such as instituting
new insulin or switching from multiple daily injections
(MDI) to pump therapy] (2|QEEE).
3.0 RT-CGM in adult outpatients
3.1 We recommend that RT-CGM devices be used by
adult patients with T1DM who have HbA1c levels of at
least 7.0% and who have demonstrated that they can use
these devices on a nearly daily basis (1|QQQQ).
3.2 We recommend that RT-CGM devices be used by
adult patients with T1DM who have HbA1c levels less
than 7.0% and who have demonstrated that they can use
these devices on a nearly daily basis (1|QQQQ).
3.3 We suggest that intermittent use of CGM systems
designed for short-term retrospective analysis may be of
benefit in adult patients with diabetes to detect nocturnal
hypoglycemia, the dawn phenomenon, and postprandial
hyperglycemia, and to assist in the management of hypo-
glycemic unawareness and when significant changes are
made to their diabetes regimen (such as instituting new
insulins or switching from MDI to pump therapy)
(2|QEEE).
Method of Development of Evidence-
Based Clinical Practice Guidelines
The Clinical Guidelines Subcommittee of The Endo-
crine Society deemed continuous glucose monitoring
(CGM) a priority area in need of practice guidelines and
appointed a Task Force to formulate evidence-based
recommendations. The Task Force followed the ap-
proach recommended by the Grading of Recommenda-
tions, Assessment, Development, and Evaluation
(GRADE) workgroup, an international group with ex-
pertise in development and implementation of evidence-
based guidelines (1). A detailed description of the grad-
ing scheme has been published elsewhere (2). The Task
Force used the best available research evidence that Task
Force members identified and one commissioned system-
atic literature review of randomized controlled trials of
CGM use (3) to inform some of the recommendations. The
Task Force also used consistent language and graphical
descriptions of both the strength of a recommendation and
the quality of evidence. In terms of the strength of the
recommendation, strong recommendations use the phrase
“we recommend” and the number 1, and weak recom-
mendations use the phrase “we suggest” and the number
2. Cross-filled circles indicate the quality of the evidence,
such that QEEE denotes very low quality evidence;
QQEE, low quality; QQQE, moderate quality; and
QQQQ, high quality. The Task Force has confidence that
persons who receive care according to the strong recom-
mendations will derive, on average, more good than harm.
Weak recommendations require more careful consider-
ation of the person’s circumstances, values, and prefer-
ences to determine the best course of action. Linked to
each recommendation is a description of the evidence and
the values that panelists considered in making the recom-
mendation. All of our recommendations are expert opin-
ions and are evidence based. Some of these opinions are
based on stronger evidence than others. For strong rec-
ommendations with GRADE 1 evidence, the Task Force
has made recommendations, and for weak recommen-
dations with GRADE 2 evidence, the Task Force has
made suggestions. For recommendations in this guide-
line that are based on low-quality to very low-quality
evidence, the reader should note that our implicit rec-
ommendation is for more research.
The task force recognizes that CGM may place educa-
tional and practical burdens on patients and their families
and on diabetes care providers who must be available to
support, advise, and educate them. We also recognize that
there are costs associated with the use of this technology
according to our recommendations and that ultimately,
the routine use of this technology will depend on an evolv-
ing calculus of cost vs. effectiveness. We have considered
the cost-benefit issues related to the use of CGM and feel
that the clinical benefits justify the costs in a wide range of
patients, but that these values may not be universally
shared in some healthcare settings (e.g. those with re-
source-constrained settings, clinics unable to provide ad-
equate support to patients and families). Individuals or
health systems may disagree with our relative valuation,
and in these cases our recommendations may not apply. It
may then be necessary to modify these recommendations
accordingly.
Introduction
People who have diabetes mellitus face daily challenges in
managing glycemic levels, as well as avoiding hypoglyce-
mic and hyperglycemic excursions. Both severe hypogly-
cemia and extreme hyperglycemia have an immediate im-
pact on mental and physical functioning. Moreover, the
maintenance of glycemic control within near-normal lim-
its has been shown to significantly decrease the develop-
J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979 jcem.endojournals.org 2969
ment of secondary micro- and macrovascular complica-
tions to diabetes (4 6).
Capillary blood glucose measurements using portable
devices have been used to assess blood glucose several
times a day in an effort to provide the patient with reliable
guidance for treatment (including dietary) measures to
correct hypo- or hyperglycemia. However, even with fre-
quent blood sampling for spot glucose measurements,
some patients do not adequately manage their glycemic
levels. It has been postulated that such patients may benefit
from a system providing them with continuous real-time
glucose readings. Although this argument is intuitively
easy to accept, there remain a number of caveats to take
into account before accepting continuous monitoring of
blood glucose as a routine (or even specialized) measure to
improve glycemic control in diabetes.
First, maintaining direct access to the blood on a con-
tinuous basis for an extended period has proved imprac-
tical. Hence, a number of different techniques have been
evaluated, including invasive and noninvasive methods
for indirectly estimating blood glucose. Second, the reli-
ability in terms of accuracy and the precision of the various
systems need proper documentation before being applied
in routine care. Third, financial constraints require an on-
going evaluation of the socioeconomic consequences of
these new techniques, and therefore the eventual clinical
benefits of their use need to be documented and balanced
against their costs.
The glucose concentration in the interstitial fluid (ISF)
has proven reasonably assessable, even for long-term
monitoring in an outpatient setting, and currently the vast
majority of the available technology, as well as technology
under development, uses the ISF for monitoring directly or
indirectly. In this context, it is of particular interest that the
glucose concentration in the sc ISF has been shown to
reflect the concentrations and dynamics of glucose in the
brain (7). The present set of guidelines is not a technical
review of available technologies. Rather, this document
scrutinizes available evidence that CGM in the ISF is of
clinical value in the quest to obtain and maintain near-
normal glycemic control in various clinical situations and
subpopulations with diabetes mellitus (3).
1.0 RT-CGM in Adult Hospital Settings
Recommendation
1.1 We recommend against the use of RT-CGM alone
for glucose management in the ICU or operating room
until further studies provide sufficient evidence for its ac-
curacy and safety in those settings (1/QEEE).
1.1 Evidence
The study of van den Berghe et al. (8) in surgical ICU
patients showing marked reduction in mortality and mor-
bidity in those treated with intensive insulin therapy (IIT)
compared with conventional insulin therapy (CIT) initi-
ated a rapidly growing worldwide trend to aggressively
treat hyperglycemia in critically ill patients. However, sub-
sequent studies in medical ICU (MICU) patients, including
those by van den Berghe et al. (8), as well as in surgical and
MICU/surgical ICU patients, have been unable to dupli-
cate her results (9–13). A meta-analysis before the NICE-
SUGAR report, in fact, confirmed that there was no ben-
efit to IIT (14) in the ICU population. Furthermore, these
prospective, randomized controlled trials of IIT demon-
strated that hypoglycemia was significantly more com-
mon in those receiving IIT than in those treated with CIT.
The NICE-SUGAR study showed, in fact, an increased
mortality rate in those treated with IIT (12) (Table 1).
Although the reasons for this increased rate are unclear,
the finding is consistent with a retrospective analysis
showing that hypoglycemia was an independent risk fac-
tor for mortality (15). In one series, however, this risk was
limited to patients with spontaneous hypoglycemia, but
iatrogenic hypoglycemia after insulin therapy was not as-
sociated with a higher mortality risk (16).
These trials used a variety of bedside point-of-care
(POC) devices for testing glucose, which are listed (when
specified) in Table 1. The listed devices use glucose dehy-
drogenase for glucose determination. Recently, the Food
and Drug Administration (FDA) has warned that this
method is subject to false elevation by maltose, icodex-
trine, galactose, and xylose, although the FDA has not
proscribed their use in the hospital (17). It is unlikely,
although not impossible, that patients in intensive man-
TABLE 1. Rates of hypoglycemia in ICU patients receiving IIT vs. CIT
First author,
year (Ref.)
Hypoglycemia
in IIT (%)
Hypoglycemia
in CIT (%)
P
value Glucose method
Whole blood
source
Arabi, 2008 (9) 28.6 3.1 0.0001 Accu-Chek Inform Artery or capillary
Brunkhorst, 2008 (10) 17.0 4.1 0.001 HemoCue Artery or capillary
Devos, 2007 (11) 9.8 2.7 0.001 Not stated Not stated
Grey, 2004 (78) 32.0 7.4 0.001 Not stated Not stated
NICE-SUGAR, 2009 (12) 6.8 0.5 0.001 Blood gas analyzer Artery (mostly)
Van den Berghe, 2001 (8) 12.7 0.76 ? ABL700 Artery
Van den Berghe, 2006 (13) 3.1 18.7 0.001 HemoCue Capillary
2970 Klonoff et al. Guidelines for Continuous Glucose Monitoring J Clin Endocrinol Metab, October 2011, 96(10):2968–2979
agement studies were subject to such errors. On the other
hand, devices that use glucose oxidase are potentially sub-
ject to falsely lower than actual values in settings where
there is high oxygen tension produced by supplemental
oxygen (18). Both methods may be affected by a variety of
medications. Importantly, the requirements for accuracy
in a critical care setting have not yet been determined. Kost
et al. (19) have suggested that the margins of error for
blood glucose measurement should be within 15 mg/dl of
the reference measurement for blood sugars less than 100
mg/dl and within 15% if above 100 mg/dl in critical care
settings. It should be noted that the International Orga-
nization for Standardization (ISO) (20) suggested that the
margin of error should be within 15 mg/dl for blood sugars
less than 75 mg/dl. In addition to the issue of what stan-
dards should be applied, POC testing itself (rather than
laboratory testing) in critically ill patients is controversial
because of unresolved questions about the effects on ac-
curacy of common conditions, e.g. acidosis, hypothermia,
and hypotension; or medications, e.g. dopamine, manni-
tol, acetaminophen, and pressor use. These circumstances
reduce tissue perfusion, which may uncouple the usual
relationship between the sc and circulatory glucose. Thus,
results may differ depending not only on the source of the
sample—capillary, vein, or artery— but also on the con-
comitant cause and treatment of the patient’s ICU stay. Of
several studies investigating the accuracy of POC testing in
the ICU, some found adequate accuracy if arterial samples
were used (18, 21), whereas others generally showed mar-
ginal or clinically unacceptable accuracy with capillary
samples (22–28). Despite these findings, POC capillary
samples are the most commonly used method for obtain-
ing blood glucose measurements in the ICU. Furthermore,
several studies have used capillary-derived samples to val-
idate CGM in this setting.
With respect to ICU conditions, Kulkarni et al. (26)
found a significant discrepancy in accuracy in those
treated with IIT who had hypotension and/or were treated
with a pressor as compared with those without hypoten-
sion/pressor treatment (2 SD values from the mean differ-
ence between measurements in the low range was 36.8
mg/dl). Haupt et al. (29) found that hypothermia can cause
significant underestimation of blood glucose, and Hoede-
maekers et al. (24) found that the ISO criteria were not met
by three different meters (Accu-Chek, HemoCue, and Pre-
cision) with all readings higher than the reference stan-
dard, which can lead to potentially serious overtreatment
with insulin. Most recently, Vlasselaers et al. (30) found
significant clinical bias using both Accu-Chek and
HemoCue devices as compared with standard laboratory
testing and recommended caution in using such devices to
regulate insulin infusion rates.
CGM may have an advantage over POC testing in that
it has the potential to reduce the possibility of unknown
hypoglycemic events that may occur between POC mea-
surements. These devices use ISF rather than blood to mea-
sure glucose, but the relationship of ISF to blood in crit-
ically ill patients has been investigated only to a limited
degree. Several studies of CGM have evaluated the effects
of conditions that are common in the ICU, such as hypo-
tension with or without inotrope use, hypothermia,
edema, renal and hepatic failure, hyperinsulinemia, and
acidosis, but these studies were small and generally not
powered to assess each of those variables (Table 2) (31–
37). For example, De Block et al. (31), in a study of 50
adult ICU patients, noted worse accuracy in patients on
inotropes and better accuracy in those in acute renal fail-
ure and septic shock compared with patients on no ino-
tropes and without these conditions. However, Holzinger
et al. (33) found that there was no significant effect on
accuracy in 27 ICU patients treated with norepinephrine
for shock compared with 23 without shock, and a lack of
inotrope effect was noted in other studies (32, 37). CGM
was not affected by mild ketosis without acidosis in a study
of patients with T1DM in whom their insulin pump was
temporarily stopped in a non-ICU setting (35), but the
effect of keto- or lactic acidosis has not been evaluated.
Other studies have noted that hypotension, hypothermia,
and edema did not affect CGM accuracy (32, 36). Inter-
estingly, hyperinsulinemia itself reduced sensor glucose
compared with venous glucose readings about 20% in
humans (34). These findings differ from those in a hyper-
insulinemic hyperglycemic dog model in which sensor dy-
TABLE 2. Effects of different conditions and treatments on CGM accuracy in the ICU
First author,
year (Ref.) Condition/treatment
No. of
patients
No. of paired
samples
Accuracy
interference
De Block, 2006 (31) Inotropes ? ? Yes
Goldberg, 2004 (32) Inotrope/edema/hypotension 21 546 No
Holzinger, 2009 (33) Inotropes 50 736 No
Monsod, 2002 (34) Hyperinsulinemia 11 88 Yes
Pfutzner, 2006 (35) Ketosis 12 159 No
Price, 2008 (37) Inotropes 17 371 No
Piper, 2006 (36) Edema, hypothermia, inotropes 20 246 No
J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979 jcem.endojournals.org 2971
namics were unchanged under conditions of different in-
sulin concentrations (38).
There have been nine studies that have evaluated the
accuracy of ISF-based CGM in the ICU (23, 32, 33, 36, 37,
39 –42) (Table 3); of them, only one involved use of CGM
to control IIT (40). The other studies used retrospective
comparisons of a reference POC value with simultaneous
CGM data. Each study had a small number of patients (17
to 50, for a combined total of 256), and few data were
obtained during hypoglycemia. Goldberg et al. (32) found
that 98.7% of results were in the Clarke et al. (43) error
grid A and B zones, although they used capillary samples
as the reference method. Only four of 546 pairings found
blood glucose less than 60 mg/dl. Corstjens et al. (23)
found that 100% of the readings of MICU patients were
in the A and B zones. Holzinger et al. (33) also found
excellent clinical agreement with 98.6% in the acceptable
treatment zone and none in the life-threatening zone. In
ICU patients with continuous insulin infusions, Rabiee et
al. (41) compared the DexCom to three different methods
of glucose determination—two with capillary blood from
finger sticks (Accu-Chek and OneTouch) and one from
serum (Hitachi 917), which was used as the “gold stan-
dard” for clinical decisions. There were 85 paired values
with the Hitachi 917, and 100% of values in the A and B
zones. However, when these results and the paired data
with the Accu-Chek (1065 paired values compared with
Dexcom) and OneTouch (232 paired values compared
with Dexcom) were more closely examined, the CGM gen-
erally overestimated the actual serum glucose and missed
50% of the 30 actual hypoglycemic episodes as deter-
mined by Accu-Chek, leading the authors to conclude that
it was not sufficiently safe to be used in an ICU setting.
Blood glucose measurements on POC devices have been
used as reference methods for CGM accuracy studies, but
these devices provide readings with up to a 20% bias (or
greater in some circumstances) compared to reference val-
ues. In hospitalized patients, anemia, abnormal oxygen
tension, and hypotension can all degrade accuracy of these
devices and make it difficult to assess the simultaneous
performance of CGM. Tonyushkina et al. (44) and Mraz
et al. (40), using a computer-based predictive model con-
trol algorithm in 10 post-cardiac surgery patients, found
that 97% of readings were clinically acceptable (A and B
zones), and there were no episodes of hypoglycemia over
24 h, whereas there were five episodes in 10 patients in the
control group. In the only study in a pediatric population,
Piper et al. (36) found excellent clinical accuracy, with
98.8% in zones A and B in 20 patients after cardiac sur-
gery. However, only two of 246 paired values were less
than 75 mg/dl. Finally, Yamashita et al. (42), using an iv
CGM, found 100% in zones A and B. These promising
results are mitigated by other studies. Price et al. (37)
found a poor correlation between CGM and both capil-
lary and arterial samples when the blood sugar was less
than 81 mg/dl. CGM overestimated capillary or arterial
glucose by 18 mg/dl or more in 23% of readings less than
80 mg/dl, although there were only 36 comparisons in that
range. Logtenberg et al. (39), in comparing capillary, ar-
terial, and venous reference standards in ICU patients after
cardiac surgery, found that 96.0, 92.1, and 84.6%, re-
spectively, were within the Clarke error grid A and B
zones; and 3.3, 7.4, and 14.7%, respectively, were in the
D zone. Blood sugars less than 60 mg/dl were rare in their
study, as well. In summary, whereas the use of CGM ap-
pears promising, it must undergo larger and rigorous test-
ing in the ICU setting before it can be recommended for use
with IIT protocols. Finally, in the only randomized study,
TABLE 3. Accuracy of ISF-based CGM systems compared with POC glucometry in ICU patients
First author,
year (Ref.) Device Comparison
No. of
patients Site
No. of paired
samples
Clarke A,
B (%)
Clarke C,
D, E (%)
Corstjens, 2006 (23) CGM Arterial ABL715/
Precision PCx
19 MICU 165 100 0
Goldberg, 2004 (32) CGM Capillary 21 MICU 546 98.7 1.3
Holzinger, 2009 (33) CGM Arterial ABL700 50 MICU 736 98.6 1.4
Logtenberg, 2009 (39) RT-CGM Capillary (Accu-Chek)/
arterial
30 Post-op SICU 275/216 96/92.1 4.1/7.9
Mraz, 2009 (40) CGM/eMPC Arterial 10 SICU 24 97 3
Piper, 2006 (36) CGM Lab 20 Post-op ICU 246 98.8
a
1.2
Price, 2008 (37) RT-CGM Accu-Chek, capillary/
arterial
17 MICU? 366 Not done Not done
Rabiee, 2009 (41) CGM Arterial: Hitachi 917 19 SICU/burn ICU 84 100 0
Capillary: Accu-Chek 19 1065 99.25 0.75
OneTouch 19 232 97.41 2.59
Yamashita, 2008 (42) STG-22 Arterial ABL 800FLEX 50 SICU 200 100 0
SICU, Surgical ICU; eMPC, enhanced model predictive control algorithm.
a
Insulin titration grid analysis.
2972 Klonoff et al. Guidelines for Continuous Glucose Monitoring J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979
Mraz et al. (40) found that CGM provided better glycemic
control without hypoglycemia in comparison with stan-
dard monitoring to manage glycemia (using an enhanced
model predictive control algorithm) in an IIT protocol.
This study is a harbinger of an “artificial pancreas” and
represents a valuable and rapidly progressing area of re-
search to determine whether or not the application of so-
phisticated model predictive controller algorithms will be
sufficient to overcome the inherent inaccuracies of CGM
technology.
1.1 Values and preferences
The Task Force recommends against using CGM in
ICU settings where patients are likely to be unable to pro-
vide feedback about hypoglycemic symptoms. This rec-
ommendation is based on the limited available data re-
lated to accuracy and our concerns regarding potential
danger in their use in guiding insulin administration in an
acute-care setting, which outweighs the possible conve-
nience and trend awareness that the technology provides.
2.0 RT-CGM in Children and Adolescent
Outpatients
CGM use with either blinded or unblinded sensors pro-
vides clinical investigators with a powerful tool to assess
new outcomes in diabetes research such as the effects of
new treatments on glucose variability and exposure to
biochemical hypoglycemia.
Self-monitoring of blood glucose (SMBG) is an im-
portant component of therapy for children and adoles-
cents with T1DM for optimizing glycemic control as
well as reducing the risk for hypoglycemia. However,
standard methods for SMBG only provide patients with
intermittent, single point-in-time snapshots of glucose
levels. The readings often miss marked and sustained
hyper- and hypoglycemic excursions (45), especially
during the night when checking blood glucose is incon-
venient (46, 47).
CGM systems have been developed that allow more
complete blood glucose profiles to be obtained (48–50).
However, the first generation of FDA-approved devices
either provided data only for short-term retrospective
analysis (the MiniMed CGMS) or were too difficult and
uncomfortable to use (the GlucoWatch 2 Biographer) (51,
52). Newer RT-CGM systems provide improved accuracy
and functionality and better patient tolerance (48, 53–57).
Future CGM systems might contain software that can an-
alyze inputted clinical factors and glycemic trends to pre-
dict future glucose levels (58). However, evidence is still
being gathered regarding the efficacy, safety, tolerability,
and subjective benefits of these devices in different popu-
lations of patients with diabetes.
Recommendation
2.1 We recommend that RT-CGM with currently ap-
proved devices be used by children and adolescents with
T1DM who have achieved HbA1c levels below 7.0% be-
cause it will assist in maintaining target HbA1c levels
while limiting the risk of hypoglycemia (1|QQQQ).
2.1 Evidence
The Juvenile Diabetes Research Foundation Continu-
ous Glucose Monitoring (JDRF CGM) (59) Study Group
has demonstrated that in patients with T1DM who have
achieved HbA1c levels less than 7.0%, RT-CGM use can
reduce the frequency of biochemical hypoglycemia (which
they defined as a blood glucose level below 70 mg/dl) and
help maintain HbA1c levels less than 7.0% compared with
standard blood glucose monitoring over a 6-month study
period. Of the 129 enrolled subjects, 62 (or 48%) were
younger than 25, and 67 (or 52%) were at least 25 yr of
age. The median time per day with a glucose level of 70
mg/dl or less as measured with CGM was less in the CGM
group than in the control group; however, the difference
was not statistically significant. In this study, almost all the
other analyses (including the time per day 60 mg/dl, time
per day between 71 and 180 mg/dl, and combined out-
comes involving HbA1c coupled with hypoglycemia)
favored the CGM group compared with the control
group. Treatment effects were generally similar across
age groups.
Recommendation
2.2 We recommend RT-CGM devices be used with chil-
dren and adolescents with T1DM who have HbA1c lev-
els 7.0% who are able to use these devices on a nearly
daily basis (1|QQQE).
2.2 Evidence
The DirecNet GlucoWatch 2 Biographer (52), Guard
Control (60), STAR-1 (55), and the JDRF randomized
clinical trials [JDRF CGM RCT (61)] have all demon-
strated a usage-dependent effect of lowering HbA1c in
youth with T1DM. For example, the DirecNet Gluco-
Watch study observed no benefit of CGM use, primarily
because few if any of the subjects used this device reg-
ularly. In the 6-month JDRF CGM RCT in patients with
T1DM and HbA1c of 7.0% or greater, 83% of adults
wore their CGM devices 6–7 d/wk and lowered HbA1c
levels by 0.53% compared with controls. CGM was less
effective in HbA1c reduction in younger patients in as-
sociation with much less frequent use of the devices
J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979 jcem.endojournals.org 2973
(61). Subjects in that study aged 8–17 yr who wore the
CGM device 6–7 d/wk lowered HbA1c levels by 0.8%
without increasing the frequency of low sensor glucose
concentrations (62). Moreover, the improvement in gly-
cemic control was maintained for a full 12 months in
those subjects (21% of the pediatric cohort) who were
able to continue the frequent use of these devices. It is
also noteworthy that the incidence of severe hypogly-
cemia in the entire pediatric cohort was only 11.2 events
per 100 patient-years over the 12 months of study. For
comparison, the rate of severe hypoglycemia in inten-
sively treated adolescents in the Diabetes Control and
Complications Trial was 86 events per 100 patient-
years (63). Thus, CGM use may improve the safety of
intensive treatment of children and adolescents with
T1DM even when worn less than 6–7 d/wk.
Post hoc analyses of the JDRF CGM RCT data indicate
that there are few strong predictors that can be used to
identify which young patients with T1DM will use the
sensor on a nearly daily basis. The only baseline charac-
teristic other than older age that predicted near-daily
CGM use was frequent daily blood glucose meter testing
before entering the trial (64).
Additional data from the JDRF CGM RCT indicate
that patients’ perception of the inconvenience of using
current CGM devices is the major obstacle to more con-
sistent use of these systems (65).
In a randomized, controlled, multicenter European/Is-
raeli study of both children (ages 10–17 yr) and adults
with T1DM whose HbA1c levels were less than 7.5%, a
post hoc per protocol analysis demonstrated that time
spent in hypoglycemia below 63 mg/dl was reduced by
64% (P0.001) in the children (66).
Recommendation
2.3 We make no recommendations for or against the
use of RT-CGM by children with T1DM who are less than
8 yr of age. More research in this field is needed.
2.3 Evidence
Randomized trials in younger age groups have been
initiated, but no results have been reported yet. Limited
data from nonrandomized studies indicate that these de-
vices can be used successfully in patients less than 8 yr of
age (47, 67). The quality of evidence is insufficient to sup-
port recommendations for or against its use in this patient
population at this time.
Recommendation
2.4 We suggest that treatment guidelines be provided to
patients to allow them to safely and effectively take ad-
vantage of the information provided to them by RT-CGM
(2|QEEE).
2.4 Evidence
The DirecNet study group (68) has developed and im-
plemented useful guidelines for initiating the use of RT-
CGM. Proper training is necessary for patients and health-
care professionals to use CGM properly (69). Additional
studies are needed to evaluate the effectiveness of current
and future guidelines, with regard to the timing of a pre-
meal insulin bolus, using glucose trends during exercise,
and using RT-CGM when initiating pramlintide therapy.
Recommendation
2.5 We suggest the intermittent use of CGM systems
designed for short-term retrospective analysis in pediatric
patients with diabetes for whom clinicians worry about
nocturnal hypoglycemia, dawn phenomenon, and post-
prandial hyperglycemia; in patients with hypoglycemic
unawareness and in patients experimenting with impor-
tant changes to their diabetes regimen (such as instituting
new insulin or switching from MDI to pump therapy)
(2|QEEE). These devices represent an alternative for pa-
tients who cannot safely and effectively take advantage of
the information provided to them by RT-CGM.
2.5 Evidence
When the MiniMed CGMS was first introduced for
3-d retrospective analysis of plasma glucose profiles,
investigators quickly showed that this method of glu-
cose monitoring revealed patterns of post-meal hyper-
glycemia and nocturnal hypoglycemia that were not ev-
ident during standard SMBG testing in children with
T1DM (45, 47). Several small clinical trials suggested
that even one or two uses of the CGMS device could lead
to treatment adjustments that had long-lasting im-
provements in metabolic control of T1DM (70–73).
The validity of these findings has been cast in doubt by
the results of RT-CGM studies that indicate the need for
nearly daily use of the devices to obtain and maintain
lowering in HbA1c levels (61). Nevertheless, in the
judgment of many diabetes care providers, retrospective
analysis of short-term CGM profiles can be of benefit in
individual patients in whom the causes of persistent
elevations in HbA1c are unclear.
Sensor-augmented pump therapy vs. insulin pump
and SMBG at onset in youth with T1D
Use of CGM in combination with insulin pump therapy
during the first year of diabetes does not appear to improve
metabolic control in comparison to insulin pump therapy
2974 Klonoff et al. Guidelines for Continuous Glucose Monitoring J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979
with standard SMBG when initiated in youth with T1D at
the onset of the disease.
In the ONSET Study that involved 160 youth (aged
1–16 yr) (74), no significant difference in HbA1c levels
was observed after 12 months in subjects randomized to
sensor-augmented pump therapy (i.e. pump and CGM) in
comparison with the use of insulin pumps and standard
blood glucose meter monitoring.
3.0 RT-CGM in Adult Outpatients
Recommendation
3.1 We recommend that RT-CGM devices be used by
adult patients with T1DM who have HbA1c levels of at
least 7.0% and who have demonstrated they can use these
devices on a nearly daily basis (1|QQQQ).
3.1 Evidence
The JDRF CGM RCT (59), the GuardControl Study
(60), and O’Connell et al. (75) demonstrated that adults
with HbA1c of at least 7.0% had a greater reduction in
HbA1c with the use of RT-CGM than with intermittent
SMBG. Furthermore, unlike findings with SMBG, the im-
provement in HbA1c with CGM is not accompanied by an
increase in biochemical hypoglycemia (54, 60). The im-
provement in HbA1c in the CGM subjects in the 6-month
JDRF trial was sustained during the 6-month observa-
tional period that followed completion of the trial (76).
This ongoing benefit occurred despite reduction in office
visit frequency during this observational period to levels
(2.7 1.2 visits over 6 months) similar to routine care.
Furthermore, the incidence rate of severe hypoglycemia
declined from 20.5 events per 100 patient-years during the
initial 6-month randomized trial to 12.1 events per 100
patient-years during the 6-month observational follow-
up. In a randomized, controlled, multicenter European/
Israeli study of both children (ages 10–17 yr) and adults
with T1DM whose HbA1c levels were less than 7.5%, a
post hoc per protocol analysis demonstrated that time
spent in hypoglycemia below 63 mg/dl was reduced by
50% (P0.02) in the adults (66).
Recommendation
3.2 We recommend that RT-CGM devices be used by
adult patients with T1DM who have HbA1c levels less
than 7.0% and who have demonstrated that they can use
these devices on a nearly daily basis (1|QQQQ).
3.2 Evidence
The JDRF CGM Study Group has demonstrated that in
patients with T1DM who have achieved HbA1c levels less
than 7.0%, RT-CGM use can reduce the frequency of
biochemical hypoglycemia (which they defined as a blood
glucose level of below 70 mg/dl) and help maintain HbA1c
levels less than 7.0% compared with standard blood glu-
cose monitoring over a 6-month study period. Of the 129
enrolled subjects, 62 (or 48%) were younger than 25, and
67 (or 52%) were more than 25 yr of age. The median time
per day with a glucose level of 70 mg/dl or less as measured
with CGM was less in the CGM group than in the control
group; however, the difference was not statistically sig-
nificant. In this study, almost all the other analyses (in-
cluding the time per day 60 mg/dl, time per day between
71 and 180 mg/dl, and combined outcomes involving
HbA1c coupled with hypoglycemia) favored the CGM
group compared with the control group. Treatment effects
were generally similar across age groups (59). For the
CGM users who were 25 yr and older, the incidence rate
of severe hypoglycemia was 21.8 events per 100 person-
years during the 6-month randomized controlled trial and
7.1 events per 100 person-years during the 6 months of
continued CGM use after the conclusion of the random-
ized clinical trial (the observational period that followed
the trial). For these CGM users whose HbA1c levels were
below 7.0%, these incidences were 23.6 events per 100
person-years during the 6-month randomized controlled
trial and 0 per 100 patient-years during the 6 months of
continued CGM use after the conclusion of the random-
ized clinical trial (76). This evidence of an ongoing learn-
ing curve and improvement in glycemic control over the
long term points to the user dependence of CGM technol-
ogy, and this may partly account for the failure of other
randomized trials enrolling individuals with poorer gly-
cemic control (55) to demonstrate a reduction in severe
hypoglycemia.
Recommendation
3.3 We suggest that the intermittent use of CGM sys-
tems designed for short-term retrospective analysis may be
of benefit in adult patients with diabetes to detect noctur-
nal hypoglycemia, the dawn phenomenon, and postpran-
dial hyperglycemia, and to assist in the management of
hypoglycemic unawareness and when significant changes
are made to their diabetes regimen (such as instituting new
insulin or switching from MDI to pump therapy)
(2|QEEE). These devices represent an alternative for pa-
tients who cannot safely and effectively take advantage of
the information provided to them by RT-CGM.
3.3 Evidence
The studies and conclusions discussed in recommenda-
tion 2.6 pertain to adult patients as well as pediatric pa-
tients. There is also evidence that intermittent profiles can
provide additional insights in adults with type 2 diabetes
J Clin Endocrinol Metab, October 2011, 96(10):2968 –2979 jcem.endojournals.org 2975
mellitus regarding glucose levels and the time in target
range (77).
Conclusions
CGM can be beneficial in maintaining target levels of gly-
cemia and limiting the risk of hypoglycemia. The Task
Force used best available data to make recommendations
about the use of CGM in three clinical settings: 1) RT-
CGM in adult hospital settings; 2) RT-CGM in children
and adolescent outpatients; and 3) RT-CGM in adult out-
patients. With varying degrees of strength of evidence and
quality of evidence, the Task Force recommended the use
of CGM in the second and third settings. The routine use
of this technology will also depend in part on future de-
terminations of its cost relative to its benefits. The Task
Force recommended against using CGM in adult hospital
settings at this time and can make no recommendations
about the use of CGM in children less than 8 yr of age
because of the paucity of data.
Acknowledgments
The members of the Task Force thank The Endocrine Society’s
Clinical Guidelines Subcommittee, Clinical Affairs Core Com-
mittee, and Council for their careful, critical review of earlier
versions of this manuscript and their helpful comments and sug-
gestions. We also thank the leadership of the Diabetes Technol-
ogy Society and the European Society of Endocrinology for their
review and comments. Finally we thank the many members of
The Endocrine Society who reviewed the draft version of this
manuscript when it was posted on the Society’s web site and who
sent a great number of additional comments and suggestions,
most of which were incorporated into the final version of the
guideline.
Address all correspondence and requests for reprints to: The
Endocrine Society, 8401 Connecticut Avenue, Suite 900, Chevy
Chase, Maryland 20815. E-mail: govt-prof@endo-society.org,
Telephone: 301-941-0200. Address all commercial reprint re-
quests for orders 101 and more to: Walchli Tauber Group Inc.,
E-mail: Karen.burkhardt@wt-group.com. Address all reprint re-
quests for orders for 100 or fewer to Society Services, Telephone:
301-941-0210, E-mail: societyservices@endo-society.org, or
Fax: 301-941-0257.
Cosponsoring Associations: Diabetes Technology Society
and European Society of Endocrinology.
Financial Disclosures of the Task Force
David C. Klonoff, M.D., F.A.C.P. (chair)—Financial or Busi-
ness/Organizational Interests: Bayer, C8 MediSensors, Insu-
line, LifeScan, Medtronic Diabetes, Roche; Significant Fi-
nancial Interest or Leadership Position: Diabetes Technology
Society. Bruce Buckingham, M.D.—Financial or Business/
Organizational Interests: MedTronic MiniMed, LifeScan,
Novo Nordisk, JDRF, UnoMedical; Significant Financial In-
terest or Leadership Position: none declared. Jens S. Chris-
tiansen, M.D., F.R.C.P.I., Dr.Med.Sci.—Financial or Busi-
ness/Organizational Interests: Novo Nordisk, Roche;
Significant Financial Interest or Leadership Position: Euro-
pean Society of Endocrinology. Victor M. Montori,
M.D.*—Financial or Business/Organizational Interests:
KER Unit (Mayo Clinic); Significant Financial Interest or
Leadership Position: none declared. William V. Tambor-
lane, M.D.—Financial or Business/Organizational Interests:
Medtronic Diabetes, Abbott Diabetes, Novo Nordisk, Eli
Lilly, Macrogenics; Significant Financial Interest or Leader-
ship Position: Novo Nordisk, Eli Lilly, Medtronic, Macro-
genics. Robert A. Vigersky, M.D.—Financial or Business/
Organizational Interests: Dexcom; Significant Financial
Interest or Leadership Position: The Endocrine Society.
Howard Wolpert, M.D.—Financial or Business/Organiza-
tional Interests: Insulet, Novo Nordisk, Roche; Significant
Financial Interest or Leadership Position: Insulet. *Evidence-
based reviews for this guideline were prepared under con-
tract with The Endocrine Society.
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... The treatment of diabetes, in particular that of type 1 diabetes, has deeply changed due to the increasingly use of technologies both for continuous glucose monitoring (CGM), and for continuous insulin infusion (Continuous Subcutaneous Insulin Infusion, CSII) and their integration through the use of automatic systems equipped with algorithms (Advance Hybrid Closed Loop, AHCL) [1][2][3][4]. Therefore, the use of sensor metric parameters, which provide much more precise information on metabolic trends (not just blood glucose assessment mean and standard deviation but evaluation of glycemic variability in terms of coefficient of variation, Time in Range, Time above Range, Time Below Range) has been added to glycated hemoglobin (HbA1c) [5][6][7][8]. ...
... Additionally, TAR >250 and TBR <54 have a higher weight than TAR 180-250 and TBR 54-69 , respectively. Thus, improvement in severe hypoglycemia and hyperglycemia is represented more prominently with the GRI [5]. ...
... This study evidenced for the first time a GRI reduction among type adult 1 diabetic patients using three different types of AHCL systems. While improvements in severe hypoglycemia and hyperglycemia are typically more pronounced in the GRI [5,12], our cohort showed that GRI improvement was mainly driven by reductions in hyperglycemia and TIR, as revealed by our association analysis. ...
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Background Advanced Hybrid Closed-Loop system (AHCL) has profoundly changed type 1 diabetes therapy. This study primarily aimed to assess the impact on Glycemia Risk Index (GRI) and other continuous glucose monitoring (CGM) metrics when switching from one of four insulin strategies to AHCL in type 1 adult patients. Methods A single-center, retrospective pre/post observational study; 198 patients (age 44.4 ± 12.7 years, 115 females/83 males, diabetes duration 24.7 ± 11.6 years, HbA1c 7.4 ± 1%), treated with different insulin therapies (MDI, CSII, SAP with PLGS, HCL) were assessed before and after switching to an AHCL (MiniMed 780G, Diabeloop Roche, Tandem Control-IQ) at 1, 3, 6, and 12 months. Mixed-effects multivariable regression models were used to estimate the mean pre/post variations at different time points, adjusted for potential confounders. Results A month after the switch, there was an improvement in CGM metrics and HbA1c for all patients: GRI −10.7, GMI −0.27%, CV −2.1%, TAR>250 −3.7%, TAR180-250 −5.6%, TIR + 9.7%, HbA1c −0.54% (all p < 0.001). This improvement was maintained throughout the observational period (at 3, 6, and 12 months, with all p-values < 0.001). When improvements across the 780, Diabeloop, and Tandem CIQ devices were compared: Diabeloop demonstrated significantly better performance in terms of GRI, GMI, CV, TAR>250 at T1 (for all p < 0.01); 780 recorded highest average decrease in TAR180-250 (p = 0.020), while Tandem achieved the most significant reduction in TBR54-69 (p = 0.004). Conclusions Adopting an AHCL leads to a rapid and sustained improvement in GRI and other parameters of metabolic control for up to a year, regardless of prior insulin therapies, baseline conditions or brands.
... The assessment of chronic control using glycated hemoglobin (HbA1c) is considered a less accurate measure than continuous interstitial glucose monitoring, either real-time (rt-CGM) or flash (FGM), to determine the optimal approach for patient management [5][6][7]. In addition, HbA1c does not allow an appropriate assessment of glycemic variability, time spent in hypoglycemia or within the glucose range, which are becoming increasingly important in clinical practice [8,9]. ...
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Aims This study aimed to determine the minimum frequency of flash glucose monitoring (FGM) scans necessary for optimal glycemic control in patients with type 1 diabetes (T1D). Methods Data were collected from 692 patients (47.5% female, with a median age of 47.4 years) who used FGM systems daily and recorded their clinical variables and device data. Results Logistic regression models showed that performing more than 12 scans per day was associated with improved T1D control (OR = 4.22, p < 0.001) and a reduction in HbA1c (7.6 vs 7.0%, 60–53 mmol/mol p < 0.001). However, those performing less than 6 scans showed no improvement in HbA1c (7.9 vs 7.8%, 63–61 mmol/mol p = 0.514). Thirteen daily scans were determined as the optimal cutoff point for predicting optimal glycemic control using a maximally selected rank algorithm. Significant reductions were observed in mean glucose (< 0.001), coefficient of variation (< 0.001), HbA1c (< 0.001), and an increase in TIR (< 0.001) in patients who performed more than 12 daily scans. Conclusions The results suggest that a higher frequency of daily scans by T1D patients using FGM systems leads to improved chronic glycemic control. The minimum recommended frequency for optimal control is 13 scans per day, and more than 6 daily scans are needed to improve HbA1c.
... Vor der Entlassung sollte eine Konsultation des behandelnden Diabetesteams erfolgten, sodass Pumpeneinstellungen überprüft und an die geänderten Bedingungen nach dem Krankenhausaufenthalt angepasst werden können [79]. Neben den generell bekannten Faktoren (Zeitverzögerung des subkutanen Signals, Sensordrift, Notwendigkeit der regelmäßigen Kalibration, Kalibration unter stabiler Glykämie), welche die CGM-Genauigkeit beeinflussen, kann die Genauigkeit des subkutanen CGM-Signals insbesondere unter stationären Bedingungen durch bestimmte Situationen (Harnsäurekonzentration, Dehydratation, Vasokonstriktion, Hypotonie, Hypothermie, Hypoxie, stark fallende Blutzuckerkonzentration) sowie Medikamente (Paracetamol, Maltose, Ascorbinsäure, Mannitol, Heparin, Salicylsäure, Hydroxyurea) zusätzlich beeinflusst werden [80][81][82]. ...
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Zusammenfassung Dieses Positionspapier beinhaltet die Empfehlungen der Österreichischen Diabetes Gesellschaft zum Management von erwachsenen Patient:innen mit Diabetes mellitus während stationärer Aufenthalte und basiert auf aktueller Evidenz zu Blutglukosezielbereichen, Insulintherapie und Therapie mit oralen/injizierbaren Antidiabetika während stationärer Aufenthalte. Zusätzlich werden Spezialsituationen wie intravenöse Insulintherapie, begleitende Steroidtherapie sowie die Anwendung von Diabetestechnologie im stationären Bereich diskutiert.
... Der Einsatz von CGM im intramuralen Bereich wird im Kapitel Diabetesmanagement im Krankenhaus diskutiert [59]. Für das perioperative Management sollten potenziell interferierende Faktoren der CGM-Messgenauigkeit (Hypothermie, Diathermie, Hypoxie, Medikamente, Durchblutung, Lagerung, chronische Nierenerkrankung) sowie die fehlende Zulassung in Österreich kommerziell erhältlicher Systeme für diese Indikation beachtet werden [7,[60][61][62][63][64]. In einem Kollektiv nach Kardiochirurgie (N = 60, 26,7 % mit Diabetes) konnte eine akzeptable CGM-Genauigkeit bei kurzer Nachbeobachtung von 23 h gezeigt werden [65]. ...
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Zusammenfassung Das vorliegende Positionspapier beschreibt die Sicht der Österreichischen Diabetes Gesellschaft hinsichtlich des perioperativen Managements von Menschen mit Diabetes mellitus auf Basis der verfügbaren wissenschaftlichen Evidenz. Dabei wird Bezug genommen auf die präoperative Begutachtung und Vorbereitung sowie auf die perioperative Stoffwechselkontrolle mittels oraler Antidiabetika und/oder injektabler Therapie (Insulin‑/GLP-1-RA-therapie).
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Background Hospital Hyperglycemia (HH) is linked to poorer outcomes, including higher mortality rates, increased ICU admissions, and extended hospital stays, and occurs in both people living with diabetes or not. The prevalence of HH in non-critical patients ranges from 22 to 46%. This panel reviewed the evidence and made recommendations for the best care for hospitalized hyperglycemic patients, with or without diabetes mellitus. Methods The methodology was published previously and was defined by the internal institutional steering committee. The SBD Acute and Hospital Complications Department drafted the manuscript, selecting key clinical questions for a narrative review using MEDLINE via PubMed. The best available evidence was reviewed, including randomized clinical trials (RCTs), meta-analyses, and high-quality observational studies related to Hospital Hyperglycemia. Results and conclusions The department members and external experts developed 23 recommendations for the management of patients with HH, including screening, initial interventions, treatment adjustments, and care for potential complications. Based on the best available evidence, our article provides safe and effective management strategies for both public and private healthcare settings.
Article
Background While continuous glucose monitoring (CGM) has transformed the care of people with diabetes (PWD) in the ambulatory setting, there continue to be significant barriers to access. With CGM on the horizon in the acute care setting, it is important to consider the potential for this shift to improve ambulatory CGM access to those at the highest risk of morbidity and mortality. Methods In this commentary, we review the existing literature on the specific barriers to CGM access for individuals with diabetes in the United States including racial disparities, provider bias, cost and shortage of specialty diabetes care. Key areas explored include the importance of CGM in diabetes management, the consequences of disparities in access to CGM, and leveraging the inpatient setting to promote equitable care and better outcomes for PWD. Results We present a vision for a new care model, which leverages the transition of care from the hospital to successfully incorporate CGM into the discharge plan. Conclusions Given that CGM utilization is associated with improved outcomes and reduced rates of hospitalization and emergency department visits, a care model that facilitates CGM access upon transition from inpatient to ambulatory care can enhance health equity and quality of life for people with diabetes.
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Long term diabetic complications can be prevented or reduced by achieving good metabolic control, reflected by HbA1c <6.5–7.0%.1-3 Glucose excursions might also contribute to the development of diabetic complications.4,5 Fear of hypoglycemia limits the ability to reach strict glycemic control, because it is usually accompanied by reluctance of the patient to intensify insulin therapy. Indeed, the goal of intensive therapy is to normalize HbA1c and control fasting and postprandial glycemia, while concurrently limiting the number and severity of hypoglycemic events. To reach tight glycemic control, frequent self- monitoring of blood glucose (SMBG) must be performed.6 SMBG devices provide the patient with accurate but discreet blood glucose levels. They do not provide trend information nor do they reflect glycemic fluctuations, which is possible by using continuous glucose monitoring (CGM) systems. Thus, implementation of strict glycemic control may be facilitated by a CGM device. This manuscript critically reviews the proposed benefits and indications of CGM and the current evidence of CGM on health outcomes in diabetic patients.
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Background: Diabetes technology in the form of digital health or medical devices holds a promise for improving the quality of life and glycemic outcomes. A comprehensive insight into diabetes technology and its impact in Saudi Arabia and the MENA region may improve type 1 diabetes mellitus (T1DM) management. Objective: his study aimed to assess the impact of different DM-specific technologies: insulin pump therapy, continuous glucose monitoring (CGM), and automated insulin delivery system in terms of glycemic control and QoL among T1DM patients in Saudi Arabia and the MENA region. Method: A systematic literature search was performed in PubMed and Scopus from 2005 until August 2023. The search was based on the PICO strategy, focusing on T1DM patients, diabetes technology, and QoL. The inclusion criteria were studies illustrating the effect of diabetes technologies on glycemic control or quality of life or both among T1DM patients. Systematic reviews, books, letters, or studies, including type 2 diabetes mellitus, were excluded. Results: From 101 articles, eighteen studies were duplicated, and thirty-three studies were excluded after reading the title and abstract. Of the 50 articles analyzed, twenty-five articles did not meet the inclusion criteria. Therefore, 25 articles involving a total of 3088 participants were enrolled in the study. It was shown that a continuous glucose monitoring system and continuous subcutaneous insulin infusion improved the glycemic control and the QoL of T1DM patients. Conclusion: There was a positive impact of insulin pumps, continuous glucose monitoring (CGM) systems, and telemedicine in achieving optimal glucose control and better QoL. Further studies are recommended to clarify the significant role of advanced diabetes technologies.
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Objectives: To suggest how continuous glucose monitoring (CGM) may be used intermittently in individuals with type 2 diabetes (T2D). Materials and methods: The use of CGM is largely in those with type 1 diabetes (T1D), in whom it makes sense to use CGM continuously as CGM provides a valuable tool to not only adjust their insulin doses but also to match it with their diet, physical activity, and other lifestyle modifications. In the case of T2D, however, especially for those not on insulin, the use of CGM may not be needed on a continuous basis. The use of CGM on an intermittent basis is rarely discussed in the literature. This article tries to provide clinical situations where CGM can be used intermittently. Results: Intermittent use of CGM defined as the "use of CGM once in 2 or 3 months or a fixed frequency," and may be useful in several situations in those with T2D. We suggest the following indications for the intermittent use of CGM in T2D-newly diagnosed patients where treatment is being started, uncontrolled diabetes where treatment is being altered, starting intensive lifestyle modification, during infections, during preoperative control, in children and adolescents with T2D, as a motivational tool to improve behavioral modification, after metabolic surgery, and in patients on steroids, apart from other indications. Conclusion: Intermittent use of CGM in T2D can be useful in special situations and can also be cost saving particularly in resource-constrained regions of the world.
Article
Hyperglycemia is commonly encountered in extremely preterm newborns and physiologically can be attributed to immaturity in several biochemical pathways related to glucose metabolism. Although hyperglycemia is associated with a variety of adverse outcomes frequently described in this population, evidence for causality is lacking. Variations in definitions and treatment approaches have further complicated the understanding and implications of hyperglycemia on the immediate and long-term effects in preterm newborns. In this review, we describe the relationship between hyperglycemia and organ development, outcomes, treatment options, and potential gaps in knowledge that need further research. IMPACT: Hyperglycemia is common and less well described than hypoglycemia in extremely preterm newborns. Hyperglycemia can be attributed to immaturity in several cellular pathways involved in glucose metabolism in this age group. Hyperglycemia has been shown to be associated with a variety of adverse outcomes frequently described in this population; however, evidence for causality is lacking. Variations in definitions and treatment approaches have complicated the understanding and the implications of hyperglycemia on the immediate and long-term effects outcomes. This review describes the relationship between hyperglycemia and organ development, outcomes, treatment options, and potential gaps in knowledge that need further research.
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Objective: The aim of this study was to determine the accuracy of the Guardian RT system (Medtronic Minimed, Northridge, CA) in young children and adolescents with type 1 diabetes (T1D) during different scenarios of glucose levels and sensor age. Methods: At five clinical centers, 30 subjects between 4 and 17 years old with T1D were recruited. All subjects had a glycosylated hemoglobin level of <or=10.0% and were using an insulin pump. Subjects initially used a Guardian RT for approximately 1 week at home. Each subject was then hospitalized overnight for about 18 h in a clinical research center, during which time insulin-induced hypoglycemia occurred, along with frequently sampled glucose. Results: There were 1,511 laboratory glucose measurements paired with glucose measurements from 48 Guardian RT sensors. Overall, the median absolute difference (AD) was 21 mg/dL, and the median relative AD (RAD) was 14%, with 64% of sensor values meeting International Organization for Standardization home glucose meter criteria. The median AD was 27 mg/dL for reference glucose values<or=60 mg/dL and 25 mg/dL for reference glucose values<or=70 mg/dL. The median RAD was 19% for reference glucose values 71-120 mg/dL, 14% for reference glucose values 121-180 mg/dL, and 10% for reference glucose values>180 mg/dL. Conclusions: The Guardian RT appears to perform as well in children with T1D as it has been reported to perform in adults with diabetes. The Guardian RT has an accuracy similar to that of other available continuous glucose monitors and can give important and useful clinical information.
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Objective: To evaluate long-term effects of continuous glucose monitoring (CGM) in intensively treated adults with type 1 diabetes. Research design and methods: We studied 83 of 86 individuals >or=25 years of age with type 1 diabetes who used CGM as part of a 6-month randomized clinical trial in a subsequent 6-month extension study. RESULTS After 12 months, median CGM use was 6.8 days per week. Mean change in A1C level from baseline to 12 months was -0.4 +/- 0.6% (P < 0.001) in subjects with baseline A1C >or=7.0%. A1C remained stable at 6.4% in those with baseline A1C <7.0%. The incidence rate of severe hypoglycemia was 21.8 and 7.1 events per 100 person-years in the first and last 6 months, respectively. Time per day with glucose levels in the range of 71-180 mg/dl increased significantly (P = 0.02) from baseline to 12 months. Conclusions: In intensively treated adults with type 1 diabetes, CGM use and benefit can be sustained for 12 months.
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Objective: To evaluate factors associated with successful use of continuous glucose monitoring (CGM) among participants with intensively treated type 1 diabetes in the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Clinical Trial. Research design and methods: The 232 participants randomly assigned to the CGM group (165 with baseline A1C >or=7.0% and 67 with A1C <7.0%) were asked to use CGM on a daily basis. The associations of baseline factors and early CGM use with CGM use >or=6 days/week in the 6th month and with change in A1C from baseline to 6 months were evaluated in regression models. Results: The only baseline factors found to be associated with greater CGM use in month 6 were age >or=25 years (P < 0.001) and more frequent self-reported prestudy blood glucose meter measurements per day (P < 0.001). CGM use and the percentage of CGM glucose values between 71 and 180 mg/dl during the 1st month were predictive of CGM use in month 6 (P < 0.001 and P = 0.002, respectively). More frequent CGM use was associated with a greater reduction in A1C from baseline to 6 months (P < 0.001), a finding present in all age-groups. Conclusions: After 6 months, near-daily CGM use is more frequent in intensively treated adults with type 1 diabetes than in children and adolescents, although in all age-groups near-daily CGM use is associated with a similar reduction in A1C. Frequency of blood glucose meter monitoring and initial CGM use may help predict the likelihood of long-term CGM benefit in intensively treated patients with type 1 diabetes of all ages.
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Aim: In postcardiac surgery patients, we assessed the performance of a system for intensive intravenous insulin therapy using continuous glucose monitoring (CGM) and enhanced model predictive control (eMPC) algorithm. Methods: Glucose control in eMPC-CGM group (n = 12) was compared with a control (C) group (n = 12) treated by intravenous insulin infusion adjusted according to eMPC protocol with a variable sampling interval alone. In the eMPC-CGM group glucose measured with a REAL-Time CGM system (Guardian RT) served as input for the eMPC adjusting insulin infusion every 15 minutes. The accuracy of CGM was evaluated hourly using reference arterial glucose and Clarke error-grid analysis (C-EGA). Target glucose range was 4.4-6.1 mmol/L. Results: Of the 277 paired CGM-reference glycemic values, 270 (97.5%) were in clinically acceptable zones of C-EGA and only 7 (2.5%) were in unacceptable D zone. Glucose control in eMPC-CGM group was comparable to C group in all measured values (average glycemia, percentage of time above, within, and below target range,). No episode of hypoglycemia (<2.9 mmol) occurred in eMPC-CGM group compared to 2 in C group. Conclusion: Our data show that the combination of eMPC algorithm with CGM is reliable and accurate enough to test this approach in a larger study population.
Article
background Intensive diabetes therapy aimed at achieving near normoglycemia reduces the risk of microvascular and neurologic complications of type 1 diabetes. We studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term inci- dence of cardiovascular disease. methods The DCCT randomly assigned 1441 patients with type 1 diabetes to intensive or conventional therapy, treating them for a mean of 6.5 years between 1983 and 1993. Ninety-three percent were subsequently followed until February 1, 2005, during the observational Epidemiology of Diabetes Interventions and Complications study. Cardiovascular disease (defined as nonfatal myocardial infarction, stroke, death from cardiovascular disease, confirmed angina, or the need for coronary-artery revascularization) was assessed with standardized measures and classified by an in- dependent committee. results During the mean 17 years of follow-up, 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment. Intensive treat- ment reduced the risk of any cardiovascular disease event by 42 percent (95 percent confidence interval, 9 to 63 percent; P = 0.02) and the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 57 percent (95 percent confidence interval, 12 to 79 percent; P = 0.02). The decrease in glycosylated hemo- globin values during the DCCT was significantly associated with most of the posi- tive effects of intensive treatment on the risk of cardiovascular disease. Microalbu- minuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease, but differences between treatment groups remained signifi- cant (P≤0.05) after adjusting for these factors. conclusions Intensive diabetes therapy has long-term beneficial effects on the risk of cardiovas- cular disease in patients with type 1 diabetes.