Journal of diabetes science and technology

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ISSN 1932-2968

Publications in this journal

  • Jens J Holst · John B Buse · Helena W Rodbard · Sultan Linjawi · Vincent C Woo · Trine Welløv Boesgaard · Kajsa Kvist · Stephen C Gough
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    ABSTRACT: Objective: IDegLira is a novel, fixed-ratio combination of the long-acting basal insulin, insulin degludec, and the long-acting glucagon-like peptide-1 analog liraglutide. We studied the effect of IDegLira versus its components on postprandial glucose (PPG) in type 2 diabetes. Methods: In this substudy, 260 (15.6%) of the original 1663 patients with inadequate glycemic control participating in a 26-week, open-label trial (DUAL I) were randomized 2:1:1 to once-daily IDegLira, insulin degludec or liraglutide. Continuous glucose monitoring (CGM) for 72 hours and a meal test were performed. Results: At week 26, IDegLira produced a significantly greater decrease from baseline in mean PPG increment (normalized iAUC0-4h) than insulin degludec (estimated treatment difference [ETD] -12.79 mg/dl [95% CI: -21.08; -4.68], P = .0023) and a similar magnitude of decrease as liraglutide (ETD -1.62 mg/dl [95% CI: -10.09; 6.67], P = .70). CGM indicated a greater reduction in change from baseline in PPG increment (iAUC0-4h) for IDegLira versus insulin degludec over all 3 main meals (ETD -6.13 mg/dl [95% CI: -10.27, -1.98], P = .0047) and similar reductions versus liraglutide (ETD -1.80 mg/dl [95% CI: -2.52, 5.95], P = .4122). Insulin secretion ratio and static index were greater for IDegLira versus insulin degludec (P = .048 and P = .006, respectively) and similar to liraglutide (P = .45 and P = .895, respectively). Conclusions: Once-daily IDegLira provides significantly better PPG control following a mixed meal test than insulin degludec. The improvement is at least partially explained by higher endogenous insulin secretion and improved beta cell function with IDegLira. The benefits of liraglutide on PPG control are maintained across all main meals in the combination.
    Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815610124
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    ABSTRACT: In this article, we present several important contributions necessary for enabling an artificial endocrine pancreas (AP) system to better respond to exercise events. First, we show how exercise can be automatically detected using body-worn accelerometer and heart rate sensors. During a 22 hour overnight inpatient study, 13 subjects with type 1 diabetes wearing a Zephyr accelerometer and heart rate monitor underwent 45 minutes of mild aerobic treadmill exercise while controlling their glucose levels using sensor-augmented pump therapy. We used the accelerometer and heart rate as inputs into a validated regression model. Using this model, we were able to detect the exercise event with a sensitivity of 97.2% and a specificity of 99.5%. Second, from this same study, we show how patients' glucose declined during the exercise event and we present results from in silico modeling that demonstrate how including an exercise model in the glucoregulatory model improves the estimation of the drop in glucose during exercise. Last, we present an exercise dosing adjustment algorithm and describe parameter tuning and performance using an in silico glucoregulatory model during an exercise event.
    Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815609371
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    ABSTRACT: Background: Meal lipids (LIP) and proteins (PRO) may influence the effect of insulin doses based on carbohydrate (CHO) counting in patients with type 1 diabetes (T1D). We developed a smartphone application for CHO, LIP, and PRO counting in daily food and assessed its usability in real-life conditions and potential usefulness. Methods: Ten T1D patients used the android application for 1 week to collect their food intakes. Data included meal composition, premeal and 2-hour postmeal blood glucose, corrections for hypo- or hyperglycemia after meals, and time for entering meals in the application. Meal insulin doses were based on patients' CHO counting (application in blinded mode). Linear mixed models were used to assess the statistical differences. Results: In all, 187 meals were analyzed. Average computed CHO amount was 74.37 ± 31.78 grams; LIP amount: 20.26 ± 14.28 grams and PRO amount: 25.68 ± 16.68 grams. Average CHO, LIP, and PRO contents were significantly different between breakfast and lunch/dinner. The average time for meal entry in the application moved from 3-4 minutes to 2.5 minutes during the week. No significant impact of LIP and PRO was found on available blood glucose values. Conclusion: Our study shows CHO, LIP, and PRO intakes can be easily captured by an application on smartphone for meal entry used by T1D patients. Although LIP and PRO meal contents did not influence glucose levels when insulin doses were based on CHO in this pilot study, this application could be used for further investigation of this topic, including in closed-loop conditions.
    Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815607861
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    ABSTRACT: Regular physical activity (PA) promotes numerous health benefits for people living with type 1 diabetes (T1D). However, PA also complicates blood glucose control. Factors affecting blood glucose fluctuations during PA include activity type, intensity and duration as well as the amount of insulin and food in the body at the time of the activity. To maintain equilibrium with blood glucose concentrations during PA, the rate of glucose appearance (Ra) to disappearance (Rd) in the bloodstream must be balanced. In nondiabetics, there is a rise in glucagon and a reduction in insulin release at the onset of mild to moderate aerobic PA. During intense aerobic -anaerobic work, insulin release first decreases and then rises rapidly in early recovery to offset a more dramatic increase in counterregulatory hormones and metabolites. An "exercise smart" artificial pancreas (AP) must be capable of sensing glucose and perhaps other physiological responses to various types and intensities of PA. The emergence of this new technology may benefit active persons with T1D who are prone to hypo and hyperglycemia.
    Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815609370
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    ABSTRACT: Background: The aim of this study was to compare glycemic control between SMBG-continued and -discontinued subjects with type 2 diabetes in the SMBG-OHA study. Method: Of the 96 subjects from the SMBG-OHA study, 59 were recruited for the 24-week, comparison follow-up study. The study outcomes were the differences in change in HbA1c levels at 24 weeks between the 2 groups, and change in SMBG frequency in SMBG-continued subjects. Results: Although health insurance does not cover the cost of SMBG, 22.0% of subjects continued SMBG of their own will after the SMBG-OHA study was completed. HbA1c levels were maintained from 6.81 ± 0.55% to 6.64 ± 0.53% in SMBG-continued subjects. Conversely, HbA1c levels were increased from 7.18 ± 0.63% to 7.48 ± 0.84% in SMBG-discontinued subjects. HbA1c levels were significantly different by 0.83 ± 0.25% (95% CI: -1.33 to -0.36). The difference in change in HbA1c between the groups was -0.46% (95% CI: -0.78 to -0.15). SMBG frequency was decreased from 2.02 ± 1.06 to 1.53 ± 0.86 times a day. Conclusions: HbA1c levels were maintained in SMBG-continued subjects but increased in SMBG-discontinued subjects. The study implied that almost once daily SMBG is helpful to maintain glycemic control in non-insulin-treated type 2 diabetes.
    Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815608869
  • Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815608871
  • Journal of diabetes science and technology 10/2015; DOI:10.1177/1932296815609628
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    ABSTRACT: Purpose: This feasibility study was designed to examine if remote communication technology can be used in the technical training of an insulin pump in adults with diabetes who were familiar with insulin pump therapy. Methods: Surveys were emailed to 69 individuals who purchased an insulin pump and had been trained by the manufacturer's diabetes educators. In consultation with providers, participants were given the choice of receiving training in a face-to-face meeting or via remote communication technology. The survey consisted of 27 questions asking participants' characteristics, device proficiency, confidence, and their satisfaction with the insulin pump and the training method. Differences between the 2 groups were examined using bivariate analyses. Results: There were 17 participants in the remote group and 20 participants in the face-to-face group. Participants had a mean age of 40.9 ± 14.3 years, had diabetes for 24.3 ± 13.8 years, and used an insulin pump for 9.8 ± 4.9 years. The participants in both groups were not statistically different in age, diabetes history, years on insulin pump, device proficiency, confidence, or satisfaction with the training method. The remote group reported less graduate-level education (P < .05) and higher satisfaction scores with the insulin pump training (P < .05). Conclusion: Although this study has limitations associated with the small sample size and self-selection bias, the results suggest that remote communication technology may be an effective tool to provide technical training to adults who are familiar with insulin pump therapy. Additional research is required to determine the effectiveness of the remote insulin pump training.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815606917
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    ABSTRACT: Background: Elevated fasting intact proinsulin is a biomarker of late-stage ß-cell-dysfunction associated with clinically relevant insulin resistance. In this pilot investigation, we explored the potential value of measuring intact proinsulin as a functional predictor of ß-cell exhaustion during an oral glucose tolerance test (OGTT). Methods: The study was performed with 31 participants, 11 of whom were healthy subjects (7 female, age: 59 ± 20 years), 10 had impaired glucose tolerance (IGT, 6 female, 62 ± 10 years), and 10 had known type 2 diabetes (T2DM, 5 female, 53 ± 11 years, HbA1c: 7.0 ± 0.6%, disease duration: 8 ± 5 years). During OGTT, blood was drawn after 0 hours, 1 hour, and 2 hours for determination of glucose and intact proinsulin. Five years later, patients were again contacted to assess their diabetes status and the association to the previous OGTT results was analyzed. Results: The OGTT (0 hours/1 hour/2 hours) results were as follows: healthy subjects: glucose: 94 ± 8 mg/dL/140 ± 29 mg/dL/90 ± 24 mg/dL, intact proinsulin: 3 ± 2 pmol/L/10 ± 7 pmol/L/10 ± 5 pmol/L); IGT: glucose: 102 ± 9 mg/dL/158 ± 57 mg/dL/149 ± 34 mg/dL, intact proinsulin: 7 ± 4 pmol/L/23 ± 8 pmol/L/28 ± 6 pmol/L; T2DM: glucose: 121 ± 20 mg/dL/230 ± 51 mg/dL/213 ± 34 mg/dL; intact proinsulin: 7 ± 7 pmol/L/26 ± 9 pmol/L/27 ± 10 pmol/L). Five years later, all of the IGT and 2 of the healthy subjects had developed T2DM and one had devloped IGT. All of them had elevated 2-hour proinsulin values in the initial OGTT, while patients with normal intact proinsulin results did not develop diabetes. Conclusions: Elevated 2-hour intact proinsulin levels during OGTT were predictive for later type 2 diabetes development. Further studies need to confirm our findings in larger populations.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815607862
  • Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815607863
  • Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815606471
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    ABSTRACT: This article discusses the future direction of insulin pump technology and its relationship to the software update process. A user needs analysis revealed that respondents wanted an insulin pump software update process to function much in the same way as smartphone updates. Users of insulin pumps have the same expectations as with other ubiquitous technology such as smartphones, tablets, and laptops. The development of a software update system within a regulated environment that meets the needs of insulin pump users by allowing optional software updates that provide access to pump improvements, feature additions, or access to algorithms that provide therapy-changing technologies is a new way forward for the management of a complicated disease that affects more than 450,000 people using insulin pumps in the United States.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815604857
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    ABSTRACT: Background: Under controlled conditions, the Dose Safety artificial pancreas (AP) system controller, which utilizes "fuzzy logic" (FL) methodology to calculate and deliver appropriate insulin dosages based on changes in blood glucose, successfully managed glycemic excursions. The aim of this study was to show whether stressing the system with pizza (high carbohydrate/high fat) meals and exercise would reveal deficits in the performance of the Dose Safety FL controller (FLC) and lead to improvements in the dosing matrix. Methods: Ten subjects with type 1 diabetes (T1D) were enrolled and participated in 30 studies (17 meal, 13 exercise) using 2 versions of the FLC. After conducting 13 studies with the first version (FLC v2.0), interim results were evaluated and the FLC insulin-dosing matrix was modified to create a new controller version (FLC v2.1) that was validated through regression testing using v2.0 CGM datasets prior to its use in clinical studies. The subsequent 17 studies were performed using FLC v2.1. Results: Use of FLC v2.1 vs FLC v2.0 in the pizza meal tests showed improvements in mean blood glucose (205 mg/dL vs 232 mg/dL, P = .04). FLC v2.1 versus FLC v2.0 in exercise tests showed improvements in mean blood glucose (146 mg/dL vs 201 mg/dL, P = .004), percentage time spent >180 mg/dL (19.3% vs 46.7%, P = .001), and percentage time spent 70-180 mg/dL (80.0% vs 53.3%, P = .002). Conclusion: Stress testing the AP system revealed deficits in the FLC performance, which led to adjustments to the dosing matrix followed by improved FLC performance when retested.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815602098
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    ABSTRACT: Background: We assessed the impact of "almost daily" use of continuous glucose monitoring (CGM) in adults with type 1 diabetes who had at least 1 year of CGM experience. Methods: In this single-center survey, we utilized a 16-item questionnaire to assess changes hypoglycemia fear, incidence of emergency medical treatment and utilization of self-monitoring of blood glucose (SMBG) before and after 1 year of CGM use. Participation was restricted to individuals who used the same brand of CGM system to avoid confounding responses due to differences between commercial devices. Participants were recruited on an "as-seen" basis from a major, urban internal medicine clinic and associated diabetes education center. The questionnaire was completed during the clinic visit. Responses to the survey were analyzed by standard descriptive statistics. Results: Seventy-four patients completed the survey: 42.9 years (range: 23-71 years), 38 (51%) female, 59 current insulin pump users. Most (84%) reported wearing their devices "almost daily" (n = 58) or 3 weeks per month (n = 4). "Almost daily" users reported an 86% reduction in incidence of emergency medical treatment events (P = .0013) and >50% reduction in daily SMBG frequency (P < .0001). Reductions in hypoglycemia fear were apparent but not statistically significant (P = .7359). Conclusions: "Almost daily" use of CGM with the Dexcom G4 system reduced incidence of emergency treatment events and daily SMBG utilization among survey respondents and a trend toward reduced hypoglycemia fear. This may indicate cost savings in reduction of emergency medical intervention and likely improved quality of life without increasing safety concerns related to hypoglycemia.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815604633
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    ABSTRACT: Background: A baseline level of lipofuscin in the retinal pigment epithelium (RPE) is inevitable with age, but increased levels due to increased oxidative stress can result in deleterious vision loss at older ages. As earlier detection of differences in levels can lead to superior preventative management, we studied the relationship between lipofuscin accumulation and dietary lifestyle (vegetarian vs. nonvegetarian) in the younger, healthy South Asian population using retinal fundus autofluorescence (FAF) imaging. Methods: In this pilot study, we examined 37 healthy subjects (average age 23 years ± 1) all undergoing similar stress levels as medical students at Rutgers New Jersey Medical School. Levels of lipofuscin concentrations were imaged using a FAF retinal camera (Canon CX-1). Two images (color and FAF) were captured of the left eye and included in the analysis. FAF quantitative scoring was measured in 2 regions of the captured image, the papillo-macular region (P) and the macula (M), by determining the grayscale score of a 35.5 mm(2) rectangle in the respective regions. Standardized scores (corrected to remove baseline fluorescence) were then obtained. Means, standard deviations, and t tests were performed for comparisons. Results: Fundus autofluorescence scores of regions P and M were significantly different (P < .05) between groups. Region P was further standardized and results remained significant. Conclusions: Our preliminary results show that in this cohort, vegetarians had statistically significant lower levels of autofluorescence. These findings can have potential implications regarding long-term retinal health and risk for developing certain diseases over decades in subjects at risk for vision-threatening diseases.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815599003
  • Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815605338
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    ABSTRACT: Infusion sets for use with insulin pumps are recommended for use for 2 to 3 days to avoid local skin reactions, for example, to the insulin formulation and preservatives like meta-cresol. However, many patients use the catheters longer for economic reasons. We performed this study to investigate the tolerability of 2-day use of infusion sets in comparison to 4-day use in a real-world setting. This prospective randomized controlled crossover study with 2 × 3-month observation periods was performed with 24 type 1 patients. At baseline, patients were trained on the use of the infusion system (Medtronic /Mio® or inset™ II) and randomized to any of the 2 treatment sequences. Observation parameters included glycemic control, frequency and nature of device-related, and procedure-related adverse events and patient preference. The per-protocol analysis was performed with 22 patients (5 men, 17 women, age 39 ± 11 years, BMI 27.0 ± 3.5 kg/m2). The number of catheter related adverse events was 290 with 2-day use versus 495 with 4-day use (P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day use (P < .001). There was no difference in glycemic control between the treatment arms. Treatment satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < .05). Our results demonstrate that using the infusion sets for a longer usage period of 2-3 days resulted in a clinically relevant increase in treatment-related tolerability problems. Patients should be trained and encouraged not to use insulin pump infusion sets for a longer than the recommended time period. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 09/2015; DOI:10.1177/1932296815604438