Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2

Rabin Medical Center90 enrolled

Overview

The purpose of the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting. The proposed study is a four-segment feasibility study. One segment is a proof of concept study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms, cross-over, randomized and single-center and the third segment is four-arms, parallel, randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home. Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over (two arms) in-patient study: A total of 12 patients will participate in this part of the study. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 36 hours in hospital setting. During the first period, glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned. Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 2days in a camp setting, the total duration of the camp will be up to 6 days. In one period, glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned. Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients. Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings. The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL). Segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three week period at home. After the completion of segments 1-3, the AHCL system will be optimized and a new version of the system will be created for use in segment 4. Up to 20 subjects will participate in this part of the study. Following a minimum of 5 days run-in period, subjects will be placed in a camp setting and closed loop will be initiated. Subjects will remain in closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late meal bolus and moderate-intensity exercise. At the conclusion of the camp, subjects will continue to use the system at home in Auto Mode for a period of 21 days.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes duration \> 1 year since diagnosis * Pump therapy for at least 6 months and experience with sensor use * Age10-40 years: Age 10-30 for segments 1-3, Age 14-40 for segment 4. * 7\>HbA1c \<10.0 at time of screening visit for segments 1 and 2, \<10.0 at segments 3 and 4. * Willing to follow study instructions * Willing to perform ≥ 3 finger stick blood glucose measurements daily * Willing to perform required sensor calibrations * Patient capable of reading and understand instructions in English * Willing to have an adult experienced in the management of diabetes to live with during the outpatient phase of the protocol. Exclusion Criteria: * Subject is unable to tolerate tape adhesive in the area of sensor placement * Subject has any unresolved adverse skin condition in the area of sensor or device placement * Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks * Subject has a positive pregnancy screening test * Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception * Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit * Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit * Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit * Subject has a history of a seizure disorder * Subject has central nervous system or cardiac disorder resulting in syncope * Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease * Subjects with hematocrit lower than the normal reference range per local lab testing * Subjects with a history or findings on screening electrocardiogram of any cardiac arrhythmia * Subjects with a history of adrenal insufficiency * Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment * Any disease or condition that may influence the HbA1c testing * Subject needs to travel by air during the study duration.