Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
NCT ID: NCT02776696
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2016-06-30
2019-08-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Advanced HybridClosed Loop System (AHCL)
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.
Advanced Hybrid Closed Loop System
Hybrid Closed Loop System (HCL)
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
Hybrid Closed Loop System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Advanced Hybrid Closed Loop System
Hybrid Closed Loop System
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
10 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rabin Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Schneider Children's Medical Center
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rmc082315ctil
Identifier Type: -
Identifier Source: org_study_id