ABSTRACT Background The Omnipod 5 Automated Insulin Delivery (AID) System is safe and effective for individuals managing Type 1 diabetes (T1D). Longer‐term studies may provide additional evidence of sustained effectiveness and safety of AID system use in T1D. Methods This 12‐month extension study was conducted following a multicenter randomized controlled trial (RCT) where participants used either AID (Omnipod 5) or standard therapy (current non‐automated pump therapy) for 13 weeks. Participants in France (n = 76) could transition to or continue with AID for an additional 12 months. Glycemic, safety, and psychosocial outcomes during or at the end of the extension phase were compared with baseline or end of RCT, as appropriate. Results Seventy‐five participants enrolled in the extension phase. From RCT baseline to the end of the extension phase, time in range 70–180 mg/dL increased by 17.9% (p < 0.0001) or 4.3 h/day to 62.3%. Time above range > 180 mg/dL and mean sensor glucose decreased by 17.7% and 27.8 mg/dL (both p < 0.0001), respectively. HbA1c decreased from 8.33% to 7.18% (−1.14%; p < 0.0001). Glycemic improvements were maintained for those continuing with AID from the RCT intervention group and for those transitioning to AID from standard therapy. Diabetes Quality of Life‐brief and Hypoglycemia Confidence Scale scores were maintained or improved at 6 and 12 months compared to RCT baseline. Adverse events were infrequent (12 per 100 person‐years). Conclusions Findings support the RCT results, demonstrating safety and sustained improvements in glycemic and psychosocial outcomes with the Omnipod 5 System in adults in France with T1D over 12 months. Trial Registration: ClinicalTrials.gov NCT05409131
Éric Renard, Ruth S. Weinstock, A. Penfornis et al.· Endocrinology, Diabetes & Me...· 0 citations
Introduction Automated insulin delivery (AID) has been shown to be effective in routine care in type 1 diabetes (T1D). However, its effectiveness without prior insulin pump therapy lasting more than 6 months remains poorly investigated. Material and methods This prospective, multicenter study assessed the 6-month AID effectiveness in patients with T1D for more than one year, not previously treated with an insulin pump, with HbA1c level <10% and aged over 8 years (y). The primary study endpoint was the change in time in range (TIR, 70-180 mg/dl) from AID initiation to 6 months. Results A total of 43 patients with T1D (38 adults, 5 aged under 18y) were enrolled in 9 centers. Mean age was 37±16y, 56% were male, T1D duration was 14±12 years and baseline HbA1c level was 7.6±0.8%. Patients initiated AID (Medtronic® MiniMedTM 780G), after 2.9±1.0 months of non-automated pump therapy. After 6 months of AID (n=39), TIR increased by 17.6±11.2% (p<0.0001), % time >180 mg/dl decreased by 15.3±12.1% (p<0.0001), % time >250 mg/dl by 5.9±11.2% (p=0.0001), % time <70mg/dl by 1.5±3.4% (p<0.002), % time <54mg/dl by 0.6±2.3% (p=0.05). Mean HbA1c level decreased by 0.6±0.6% (p<0.0001) and mean sensor glucose by 20.3±37.5mg/dl (p= 0.0004). The INSPIRE questionnaire score was unchanged. Adverse events included 2 non-severe ketosis episodes and 2 local skin reactions. Conclusion AID initiation after a short period of pump therapy in T1D patients significantly improved glycemic control over 6 months, with no safety concerns but no measurable improvement in quality of life.
Éric Renard, M. Halbron, I. Banu et al.· Annales d'Endocrinologie· 0 citations
Achieving glucose targets without hypoglycaemia is the treatment goal in type 1 diabetes. Structured education, intensified insulin injection regimens, continuous glucose monitoring, automated insulin delivery, and ongoing support from a multidisciplinary team all support people with type 1 diabetes to achieve this goal. Despite these advances, significant barriers to achieving optimal management remain. Continuous intraperitoneal insulin infusion has comparable or better glucose outcomes to continuous subcutaneous insulin infusion and may reduce the frequency of hypoglycaemia, including severe episodes. Intraperitoneal insulin may be considered as a treatment modality for children and adults with type 1 diabetes using optimised intensive insulin therapy for whom subcutaneous insulin has failed due to lipoatrophy, -dystrophy or -hypertrophy, local allergy, subcutaneous insulin resistance or co-existing skin conditions. Failure of subcutaneous insulin may result in recurrent or unexplained severe hypoglycaemia or hyperglycaemia. Intraperitoneal insulin may also be considered as a treatment modality for people with type 1 diabetes with severe needle-phobia, and for those being considered for islet cell or pancreatic transplantation, or where transplantation is not available. This paper summarises current intraperitoneal insulin delivery technology, its potential risks and benefits, and an expert position statement. It is intended for use by diabetes specialist healthcare professionals, and as a reference for other healthcare professionals, commissioners, payors, people with diabetes, their carers, and advocates.
Nick S. Oliver, B. Gehr, R. Lal et al.· Diabetes, obesity and metabo...· 0 citations
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