DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home.

AIMS: Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes. METHODS: This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via a tablet computer. The primary endpoint was percentage of glucose values between 70 and 180 mg/dL. RESULTS: The ITT population comprised 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180 mg/dL) (66.6% vs 59.9%, P = 0.002) was observed with the closed-loop system vs control weekends with unchanged percentage of time below 70 mg/dL (2.3% vs 1.5%, P = 0.369). Mean weekend glucose level per participant was significantly lower (153 [142-175] vs 164 [150-186] mg/dL, P = 0.003). No safety signals were observed. CONCLUSIONS: The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use. The absence of remote monitoring did not lead to safety signals in adapting basal rates nor in administration of automated bolus corrections.

Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.