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ABSTRACT: 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.
The Journal of clinical endocrinology and metabolism 10/2011; 96(10):2968-79. · 6.50 Impact Factor
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Darrell M Wilson,
Dongyuan Xing,
Jing Cheng,
Roy W Beck,
Irl Hirsch,
Craig Kollman,
Lori Laffel,
Jean M Lawrence,
Nelly Mauras,
Katrina J Ruedy,
Eva Tsalikian, Howard Wolpert
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ABSTRACT: To determine the individual persistence of the relationship between mean sensor glucose (MG) concentrations and hemoglobin A(1c) (A1C) from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring (CGM) Randomized Trial.
MG was calculated using CGM data for 3 months before A1C measurements at 3, 6, 9, and 12 months for the CGM group and at 9 and 12 months for the control group. An MG-to-A1C ratio was included in analysis for subjects who averaged ≥4 days/week of CGM use.
Spearman correlations of the MG-to-A1C ratio between consecutive visits 3 months apart ranged from 0.70 to 0.79. The correlations for children and youth were slightly smaller than those for adults. No meaningful differences were observed by device type or change in A1C.
Individual variations in the rate of hemoglobin glycation are persistent and contribute to the inaccuracy in estimating MGs calculated from A1C levels.
Diabetes care 06/2011; 34(6):1315-7. · 8.09 Impact Factor
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Rosanna Fiallo-Scharer,
Jing Cheng,
Roy W Beck,
Bruce A Buckingham,
H Peter Chase,
Craig Kollman,
Lori Laffel,
Jean M Lawrence,
Nelly Mauras,
William V Tamborlane,
Darrell M Wilson, Howard Wolpert
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ABSTRACT: Identify factors predictive of severe hypoglycemia (SH) and assess the clinical utility of continuous glucose monitoring (CGM) to warn of impending SH.
In a multicenter randomized clinical trial, 436 children and adults with type 1 diabetes were randomized to a treatment group that used CGM (N = 224), or a control group that used standard home blood glucose monitoring (N = 212) and completed 12 months of follow-up. After 6 months, the original control group initiated CGM while the treatment group continued use of CGM for 6 months. Baseline risk factors for SH were evaluated over 12 months of follow-up using proportional hazards regression. CGM-derived indices of hypoglycemia were used to predict episodes of SH over a 24-h time horizon.
The SH rate was 17.9 per 100 person-years, and a higher rate was associated with the occurrence of SH in the prior 6 months and female sex. SH frequency increased eightfold when 30% of CGM values were ≤ 70 mg/dL on the prior day (4.5 vs. 0.5%; P < 0.001), but the positive predictive value (PPV) was low (<5%). Results were similar for hypoglycemic area under the curve and the low blood glucose index calculated by CGM.
SH in the 6 months prior to the study was the strongest predictor of SH during the study. CGM-measured hypoglycemia over a 24-h span is highly associated with SH the following day (P < 0.001), but the PPV is low.
Diabetes care 03/2011; 34(3):586-90. · 8.09 Impact Factor
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ABSTRACT: In recent years continuous subcutaneous insulin infusion pumps have become widely adopted in many parts of the world in the treatment of type 1 diabetes in adults. A comprehensive summary of all aspects of pump therapy is beyond the scope of this article, and in this review we will focus on several practical issues that in our experience are of clinical importance in the care of patients using insulin pumps. These include: benefits and risks of pump therapy, including the use of pumps to limit hypoglycemia; individual patient considerations in choosing between pump therapy and multiple daily injections; common pump-specific etiologies of erratic glucose control, including routine clinical practices that can assist with the detection of these problems; and the use of different pump bolus types for prandial insulin coverage.
Diabetes Technology & Therapeutics 06/2010; 12 Suppl 1:S11-6. · 1.93 Impact Factor
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Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group,
William V. Tamborlane,
Roy W. Beck,
Bruce W. Bode,
Bruce Buckingham,
Peter H. Chase,
Robert Clemons,
Rosanna Fiallo-Scharer,
Larry A. Fox,
Lisa K. Gilliam, [......],
Nelly Mauras,
Michael O'Grady,
Katrina J. Ruedy,
Michael Tansey,
Eva Tsalikian,
Stuart Weinzimer,
Darrell M. Wilson, Howard Wolpert,
Tim Wysocki,
Dongyuan Xing
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ABSTRACT: BACKGROUND: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. METHODS: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. RESULTS: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. CONCLUSIONS: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)
The New England journal of medicine. 10/2008; 359(14):1464-1476.
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ABSTRACT: Continuous glucose monitoring (CGM) is an evolving technology poised to redefine current concepts of glycemic control and optimal diabetes management. To date, there are few randomized studies examining how to most effectively use this new tool. Therefore, a group of eight diabetes specialists heard presentations on continuous glucose sensor technology and then discussed their experience with CGM in order to identify fundamental considerations, objectives, and methods for applying this technology in clinical practice. The group concluded that routine use of CGM, with real-time data showing the rate and direction of glucose change, could revolutionize current approaches to evaluating and managing glycemia. The need for such progress is indicated by the growing prevalence of inadequately treated hyperglycemia. Coordinating financial and educational resources and developing clear protocols for using glucose sensor technology are urgent priorities in promoting wide adoption of CGM by patients and health care providers. Finally, researchers, manufacturers, payers, and advocacy groups must join forces on the policy level to create an environment conducive to managing continuous data, measuring outcomes, and formalizing best practices.
Diabetes Technology & Therapeutics 09/2008; 10(4):232-44; quiz 245-6. · 1.93 Impact Factor
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Howard Wolpert
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ABSTRACT: Real-time continuous glucose monitoring (RT-CGM) devices provide detailed information on glucose patterns and trends, and alarms that alert the patient to both hyper- and hypoglycemia. This technology can dramatically improve the day-to-day management of patients with diabetes and promises to be a major advance in diabetes care. The safe and effective use of RT-CGM in diabetes management rests on an understanding of several physiological as well as technological issues. This article outlines the key issues that should be addressed in the training curriculum for patients starting on RT-CGM: (1) physiologic lag between interstitial and blood glucose levels and the implications for device calibration, and interpretation and use of data in diabetes management; (2) practical considerations with the use of sensor alarms and caveats in the setting of alarm thresholds; and (3) potential risk for hypoglycemia related to excessive postprandial bolusing by RT-CGM users, and the practical implications for patient training.
Journal of diabetes science and technology 03/2008; 2(2):307-10.
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ABSTRACT: The purpose of this study was to identify psychosocial issues related to diabetes, approaches to self-care, self-perceptions, and social interactions among insulin pump users with type 1 diabetes.
Adult insulin pump users participated in focus groups loosely formed on the basis of A1C level. Transcripts of focus group meetings were coded into themes by five reviewers using NVivo2 qualitative software.
Thirty adults with long-term diabetes participated in five focus groups: two with low mean +/-SD A1C (6.8 +/- 0.4%), one with mid A1C (7.80 +/- 0.3%), and two with high A1C (9.1 +/- 0.5%). Three major themes were identified: impact on diabetes self-care, emotional reactions to the insulin pump, body image, and social acceptance. Participants who described the pump as a tool to meet glycemic goals also described a more active approach to diabetes and had better glycemic control; those who discussed the pump as a panacea described more passive self-care and had poorer glycemic control. Low A1C groups reported that starting the insulin pump reminded them of feelings they experienced at their initial diabetes diagnosis, whereas the high A1C groups did not report these feelings. Women were more concerned than men about body image and social acceptance with pump use.
Active participation in self-care, realistic expectations of pump use, and emotional recall of diabetes diagnosis were associated with better glycemic control. Interventions to improve diabetes management with pump use should include evaluation and discussion of active versus passive approaches to self-care, recall of diabetes diagnosis, expectations of the pump, and pump-related self-consciousness and body image concerns. The roles of these factors in optimal diabetes management warrant further investigation.
Diabetes care 04/2007; 30(3):549-54. · 8.09 Impact Factor
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Diabetes Technology & Therapeutics 11/2005; 7(5):845-8. · 1.93 Impact Factor
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Diabetes Technology & Therapeutics 11/2005; 7(5):840-4. · 1.93 Impact Factor
