Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail

NCT02651181 | Completed

• 1 other identifier: RMC076215ctil
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp. The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark. The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,

  End of the study- day 5 of the camp

• Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during night time (12am-6am)

  End of the study- day 5 of the camp

• Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during day time (6am-12am)

  End of the study- day 5 of the camp

Secondary Outcomes (7)

• Event rate of Serious Adverse Events

  End of the study- day 5 of the camp

• Event rate of Serious Adverse Device Events

  End of the study- day 5 of the camp

• Event rate of unanticipated Adverse Device Effects

  End of the study-day 5 of the camp

• Incidence of Diabetic Ketoacidosis

  End of the study-day 5 of the camp

• Area under the curve of time in the hyperglycemia range

  End of the study-day 5 of the camp

Other Outcomes (2)

• Percentage of time in Closed Loop

  End of study -day 5 of the camp

• Total insulin dose

  End of study-day 5 of the camp

Study Arms (1)

Closed Loop System

EXPERIMENTAL

Device: HLCL- Hybrid Logic Closed Loop System

Interventions

HLCL- Hybrid Logic Closed Loop System DEVICE

All subjects wearing the HLCL System and using it with the closed loop algorithm

Closed Loop System

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• Age 18-40
• A1C \<10.0 at time of screening visit
• Willing to follow study instructions
• Willing to perform ≥ 5 finger stick blood glucose measurements daily
• Willing to perform required sensor calibrations
• Patient capable of reading and understand instructions in English

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 (e.g., psoriasis, rash, Staphylococcus infection)
• 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 5 months prior to screening visit
• Subject has had hypoglycemia resulting in loss of consciousness within the past 5 months prior to screening visit
• Subject has had an episode of diabetic ketoacidosis 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 or local lab testing
• Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
• 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
• Medtronic: collaborator

Study Sites (1)

Schneider 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, MD, Prof

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: June 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: January 2, 2020

Record last verified: 2017-01

Locations

IL (1)