The Onduo Virtual Diabetes Clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists. Adults with T2D (
Abstract Aim To compare open‐source AndroidAPS (AAPS) and commercially available Control‐IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open‐label, single‐arm clinical trial. Methods Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3‐month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3‐month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70‐80 mg/dL). Results Twenty‐five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. Conclusions The CODIAC study is the first prospective study investigating the switch between open‐source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.
Background The relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations. Objective The objective of this study is to assess the impact of frequent and persistent BA use on glycemic control among pediatric type 1 diabetes patients. Methods In this 6-month, single-center, retrospective cohort study, 104 children [61 girls, mean age: 12.7 yr, mean HbA1c 8.0 (1.6)% [64 (17.5) mmol/mol]], treated with the Accu-Chek Aviva Combo insulin pump, were observed. Frequency of BA use, HbA1c, hypoglycemia (<70 mg/dL), therapy changes, mean blood glucose, and glycemic variability (standard deviation) was assessed at baseline and month 6. Sub-analyses of the adolescent patient use (12 months) and longitudinal use (24 months) were also conducted. Results Seventy-one patients reported high frequency (HF) device use (≥50%); 33 reported low frequency (LF) use (<50%) during the study. HF users achieved lower mean (SE) HbA1c levels than LF users: 7.5 (0.1)% [59 (1.1) mmol/mol] vs. 8.0 (0.2)% [64 (2.2) mmol/mol], p = 0.0252. No between-group differences in the percentage of hypoglycemia values were seen at 6 months. HF users showed less glycemic variability (84.0 vs. 94.7, p = 0.0045) than LF users. More HF patients reached HbA1c target of <7.5 at 6 months 66.2% (+16.9) vs. 27.3% (−9.1), p = 0.0056. Similar HbA1c results were seen in adolescents and BA users at 24 months. Conclusion Frequent use of the Accu-Chek Aviva Combo insulin pump BA feature was associated with improved and sustained glycemic control with no increase in hypoglycemia in this pediatric population.
Background:Many branded analog insulins will lose patent protection during the next few years. In response, a number of companies are developing biosimilar insulins, which have the potential to lower healthcare costs and increase patient access. Although these products are not yet available in the US, it is important that patients, payers and clinicians be aware of the potential benefits as well as concerns associated with biosimilar insulins.Scope:This report provides information about these new products and discusses key questions clinicians should consider regarding biosimilar insulin.Conclusion:The biosimilar insulins being developed have the potential to provide clinical benefits that are similar to current insulin analogs at a more affordable price, thereby allowing more patients greater access to these effective therapies. However, industry and regulatory agencies must proceed with caution in bringing these new insulins to market. Clinicians must be aware of how availability of these new medications may impact patients’ adherence to their treatment regimens and begin taking steps now to address these potential issues.
Glucagon-like peptide-1 (GLP-1) has been the focus of considerable research activity in the treatment of type 2 diabetes mellitus (T2DM) because the incretin effect is significantly reduced or absent in individuals with T2DM. Thus, pharmacologic efforts to develop medications that mimic the actions of GLP-1 have become a target for improving or reversing chronic hyperglycemia. Two GLP-1 receptor agonists are commercially available: exenatide twice daily (b.i.d.) and liraglutide once daily (q.d.). Targeted and individualized intensification of diabetes management can best be accomplished with a thorough understanding of these new medications. Information was gathered through a search of MEDLINE and PubMed for GLP-1 and glycemic management in patients with type 2 diabetes. Activation of the GLP-1 receptors on the β-cells results in enhanced levels of insulin biosynthesis, β-cell proliferation, resistance to β-cell apoptosis, and enhanced β-cell survival in both humans and rodents; yet, the risk of hypoglycemia is minimized because insulin production and exocytosis occurs in a glucose-dependent manner. The efficacy and safety of the two commercially available GLP-1 receptor agonists, liraglutide and exenatide, in managing postprandial glycemia have been well documented in numerous clinical trials, in which reductions in glycosylated hemoglobin (HbA1c) levels of −0.79% to −1.12% have been demonstrated. Weight reduction/maintenance and improvements in blood pressure and lipidemia have also been reported. Because GLP-1 receptor agonists work in a glucose-dependent manner, they are likely to reduce hyperglycemia safely, without a marked fluctuation toward hypoglycemia. In the process of acutely restoring β-cell function, GLP-1 agonists may allow patients to achieve HbA1c <7% without experiencing weight gain or hypoglycemia. The ability of GLP-1 receptor agonists to improve blood pressure and postprandial lipidemia in the context of weight neutrality or weight loss may have the potential to ameliorate some of the cardiovascular risks observed in patients with T2DM.
Use of automated bolus advisors is associated with improved glycemic control in patients treated with insulin pump therapy. We conducted a study to assess the impact of using an insulin bolus advisor embedded in a blood glucose (BG) meter on glycemic control and treatment satisfaction in patients treated with multiple daily insulin injection (MDI) therapy. The study goal was to achieve >0.5% A1C reduction in most patients.This was a 26-week, prospective, randomized, controlled, multinational study that enrolled 218 MDI-treated patients with poorly controlled diabetes (202 with type 1 diabetes, 16 with type 2 diabetes) who were 18 years of age or older. Participants had mean baseline A1C of 8.9% (SD, 1.2 [74 mmol/mol]), mean age of 42.4 years (SD, 14.0), mean BMI of 26.5 kg/m(2) (SD, 4.2), and mean diabetes duration of 17.7 years (SD, 11.1). Control group (CNL) patients used a standard BG meter and manual bolus calculation; intervention group (EXP) patients used the Accu-Chek Aviva Expert meter with an integrated bolus advisor to calculate insulin dosages. Glucose data were downloaded and used for therapy parameter adjustments in both groups.A total of 193 patients (CNL, n = 93; EXP, n = 100) completed the study. Significantly more EXP than CNL patients achieved >0.5% A1C reduction (56.0% vs. 34.4%; P < 0.01). Improvement in treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire scale) was significantly greater in EXP patients (11.4 [SD, 6.0] vs. 9.0 [SD, 6.3]; P < 0.01). Percentage of BG values <50 mg/dL was <2% in both groups during the study.Use of an automated bolus advisor resulted in improved glycemic control and treatment satisfaction without increasing severe hypoglycemia.
Coordinated health coaching is associated with improved diabetes outcomes with lower cost vs. traditional diabetes management. Diabetes Health Partnership (DHP) is a telephonic coaching program designed to empower individuals with diabetes. This 12-month, observational, self-controlled multi-site study combined retrospective (6 mth pre-baseline) and prospective (6 mth post-baseline) data to assess the impact of the DHP program on A1C among 57 individuals with type 1 and type 2 diabetes. Mean change from baseline A1C (8.4±1.1%) was significant (-0.5 ± 0.9%, <0.0001) within the full cohort (n=54) but notable differences in A1C between Responders (n=27, ≥0.5% reduction) vs. Non-Responders (n=27, <0.5% reduction) were observed (Figure 1), with comparable medication changes with the exception of insulin. Differences in A1C between Responders and Non-Responders may be explained by a combination of differences in baseline A1C (8.5 ± 0.8% vs. 8.3 ± 1.2%), baseline body weight (191.2 ± 36.6 lbs vs. 201 ± 42.9 lbs) and change in body weight (-5.0 ± 10.1 lbs vs. 0.6 ± 6.7 lbs). Notably more Responders than Non-Responders had >3 coaching sessions focused on diet/nutrition (9 vs. 3, respectively). Participation in the DHP program was associated with clinically-significant improvements in glycemic control in many individuals with suboptimally controlled diabetes. Disclosure W.C. Biggs: Consultant; Self; Roche Diabetes Care. Research Support; Self; Dexcom, Inc., Gan & Lee Pharmaceuticals, Mylan, Novo Nordisk A/S, Sanofi US. A. Buskirk: Employee; Self; Roche Diabetes Care. L. Borsa: None. M.R. Lyden: None. C. Parkin: Consultant; Self; Abbott, CeQur Corporation, Dexcom, Inc., DreaMed Diabetes, Novo Nordisk Inc., Onduo, Roche Diabetes Care, Valeritas, Inc. B. Petersen: Employee; Self; Roche Diabetes Care.
We thank Telliam and Thivolet (1) for their interest in our study of the use of real-time continuous glucose monitoring (rtCGM) versus self-monitoring of blood glucose with insulin pumps and multiple daily insulin injection (MDI) therapy. However, we have some questions about their study findings.
First, it is impossible to assess the significance of their findings because they have not provided baseline values for comparison. Was there an increase or decrease in time spent with blood glucose <70 mg/dL?
Second, as shown in their Fig. 1, the time below range (TBR) ( 200 mg/dL). This suggests that while these MiniMed 640G users may have experienced less TBR, their percentage of time spent above range remained suboptimal. The recent CGM consensus report recommends a composite …
