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

NCT02776696 | Completed

• 1 other identifier: rmc082315ctil
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Closed Loop; Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of glucose sensor readings within 70 to 180 mg/dl

  Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion

Secondary Outcomes (25)

• Area Under the Curve of glucose sensor readings below 70 mg/dl

  Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion

• Percentage of glucose sensor readings below 70 mg/dl

  Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion

• Area Under the Curve of glucose sensor readings above 180 mg/dl

  Day 21 for segments 1-3 and day 31 for segment 4

• Percentage of glucose sensor readings above 180 mg/dl

  Day 20

• Average of glucose sensor readings

  Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion

Study Arms (2)

Advanced HybridClosed Loop System (AHCL)

EXPERIMENTAL

Advanced Hybrid Closed Loop System (AHCL) - all subjects wearing the study system during 36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3 or 5 days in a camp setting and 21 days at home during segment 4.

Device: Advanced Hybrid Closed Loop System

Hybrid Closed Loop System (HCL)

EXPERIMENTAL

Hybrid Closed Loop System (HCL) - all subjects wearing the study system during: 36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3

Device: Hybrid Closed Loop System

Interventions

Advanced Hybrid Closed Loop System DEVICE

Also known as: AHCL

Advanced HybridClosed Loop System (AHCL)

Hybrid Closed Loop System DEVICE

Also known as: HCL

Hybrid Closed Loop System (HCL)

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Prof

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: December 27, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)