Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
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About
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.
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
90 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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