IntroductionFor many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CGM), or insulin administration using insulin pump therapy represent optimised care in many regions. Through technological advances an advanced hybrid closed loop (AHCL) system has been developed; studies of incremental effects relative to MDI plus IS-CGM are lacking.Methods and analysisThe Advanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes (ADAPT) study is a multinational, prospective, open-label, confirmatory and exploratory randomised controlled trial to examine outcomes with the MiniMed 670G version 4.0 AHCL system (with an equivalent algorithm and commercialised as the MiniMed 780G system, referred to as AHCL) relative to MDI plus IS-CGM in adults with baseline HbA1c≥8.0%. An exploratory cohort will compare AHCL with MDI plus RT-CGM. The study will be conducted in approximately 124 adults on MDI plus either IS-CGM or RT-CGM for at least 3 months prior to screening. The primary endpoint will be the difference in mean HbA1c change from baseline to 6 months between the AHCL and the MDI plus IS-CGM arms. Secondary endpoints will include proportion of time spent in hypoglycaemic, euglycaemic and hyperglycaemic ranges.Ethics and disseminationThe ADAPT study will be conducted in accordance with the requirements of the Declaration of Helsinki and local laws and regulations, and has been approved by ethics committees. The trial will provide valuable information on the incremental benefits that may be provided by AHCL for patients failing to achieve glycaemic targets on MDI plus IS-CGM or RT-CGM and form a basis for health economic evaluations to support market access.Trial registration numberNCT04235504; Pre-results.
Background: This analysis reports the findings from a predefined exploratory cohort (cohort B) from the ADAPT (ADvanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes) study. Adults with type 1 diabetes (T1D) with suboptimal glucose control were randomly allocated to an advanced hybrid closed-loop (AHCL) system or multiple daily injections of insulin (MDI) plus real-time continuous glucose monitoring (RT-CGM). Methods: In this prospective, multicenter, exploratory, open-label, randomized controlled trial, 13 participants using MDI + RT-CGM and with HbA1c ≥8.0% were randomized to switch to AHCL (n = 8) or continue with MDI + RT-CGM (n = 5) for six months. Prespecified endpoints included the between-group difference in mean change from baseline in HbA1c, CGM-derived measures of glycemic control, and safety. Results: The mean HbA1c level decreased by 1.70 percentage points in the AHCL group versus a 0.60 percentage point decrease in the MDI + RT-CGM group, with a model-based treatment effect of −1.08 percentage points (95% confidence interval [CI] = −2.17 to 0.00 percentage points; P = .0508) in favor of AHCL. The percentage of time spent with sensor glucose levels between 70 and 180 mg/dL in the study phase was 73.6% in the AHCL group and 46.4% in the MDI + RT-CGM group; model-based between-group difference of 28.8 percentage points (95% CI = 12.3 to 45.3 percentage points; P = .0035). No diabetic ketoacidosis or severe hypoglycemia occurred in either group. Conclusions: In people with T1D with HbA1c ≥8.0%, the use of AHCL resulted in improved glycemic control relative to MDI + RT-CGM. The scale of improvement suggests that AHCL should be considered as an option for people not achieving good glycemic control on MDI + RT-CGM.
Objective: To assess whether TS & FoH improvements achieved with the MiniMed™ 780G AHCL system compared to MDI+isCGM therapy in adults with sub-optimally controlled type 1 diabetes participating in the ADAPT study phase (6 months) are maintained during the continuation phase (12 months) and reproduced in the MDI+isCGM control arm after cross over to AHCL.
Methods: TS was measured with the Diabetes Treatment Satisfaction Questionnaire status and change (DTSQs/c) and FoH with the Hypoglycemia Fear Survey (HFS). Endpoints were within-arm changes from 6 to 12 months.
Results: At 12 months, A1c (7.4%) and TS & FoH scores achieved with AHCL at 6 months were maintained (Fig). In the control arm switching to AHCL, improved A1c (7.5%) was reproduced. Mean DTSQs score increased significantly (21.9 to 29.9, P<0.0001) with significant improvements in perceived frequency of hyper (P<0.001) & hypoglycemia (P=0.0206). Results were consistent for DTSQc except no significant change in perceived frequency of hypo was observed. Median HFS score decreased by 6.5 points (P=0.0306).
Conclusion: At 12 months, improved TS & FoH observed in the AHCL arm were sustained, while substantial improvements in TS & reduced FoH were seen in the MDI+isCGM arm after switching to AHCL.
Disclosure
O.Cohen: Employee; Medtronic. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.Shin: Employee; Medtronic. R.Re: Employee; Medtronic. J.Castañeda: Employee; Medtronic. L.H.Vorrink - de groot: Employee; Medtronic. A.Ozdemir saltik: Employee; Medtronic. S.De portu: Employee; Medtronic, Stock/Shareholder; Medtronic.
Funding
Medtronic
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