Clinical trial NCT02776696: Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
Official title: Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Closed Loop
Artificial Pancreas
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: segment 1 part 1 is a single arm study, segment 1 part 2 is a is a crossover study, segment 2 is a randomized crossover study , segment 3 is a parallel study and segment 4 is a single arm study
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: Percentage of glucose sensor readings within 70 to 180 mg/dl
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Secondary outcomes:
measure: Area Under the Curve of glucose sensor readings below 70 mg/dl
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of glucose sensor readings below 70 mg/dl
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Area Under the Curve of glucose sensor readings above 180 mg/dl
timeFrame: Day 21 for segments 1-3 and day 31 for segment 4
measure: Percentage of glucose sensor readings above 180 mg/dl
timeFrame: Day 20
measure: Average of glucose sensor readings
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Standard Deviation of glucose sensor readings
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Time in glucose range of 70-180 mg/dl during day time (6am-12am)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Time in glucose range of 70-180 mg/dl during night time (12am-6am)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Area Under the Curve of glucose sensor readings above 250 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Area Under the Curve of glucose sensor readings above 300 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of glucose sensor readings above 250 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of glucose sensor readings above 300 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Area Under the Curve of glucose sensor readings below 50 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Area Under the Curve of glucose sensor readings below 60 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of glucose sensor readings below 50 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of glucose sensor readings below 60 mg/dL
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Percentage of time in Closed Loop
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Sensor mean absolute relative difference (MARD)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Total insulin dose
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Serious Adverse Events (SAE)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Serious Adverse Device Events (SADE)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Unanticipated Adverse Device Effects (UADE)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Incidence of Severe Hypoglycemia
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Incidence of Diabetic Ketoacidosis (DKA)
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
measure: Closed-loop acceptance questionnaire
timeFrame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: