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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02651181
• Date of registration: 07/01/2016
• Prospective Registration: Yes
• Primary sponsor: Rabin Medical Center
• Public title: Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail
• Scientific title: Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes -Single-arm, Single-center, in Clinic Study-The DREAMED Trail
• Date of first enrolment: June 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02651181
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Moshe Phillip, MD, Prof
• Affiliation: Rabin Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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 (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

- Any disease or condition that may influence the A1C testing e.g abnormal red blood
cell indices and iron deficiency, sickle cell disease, hemoglobinopathy



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: HLCL- Hybrid Logic Closed Loop System

Primary Outcome(s)

Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL, [Time Frame: 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) [Time Frame: 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) [Time Frame: End of the study- day 5 of the camp]

Secondary Outcome(s)

Event rate of Serious Adverse Device Events [Time Frame: End of the study- day 5 of the camp]

Incidence of Diabetic Ketoacidosis [Time Frame: End of the study-day 5 of the camp]

Area under the curve of time in the hyperglycemia range [Time Frame: End of the study-day 5 of the camp]

Event rate of Serious Adverse Events [Time Frame: End of the study- day 5 of the camp]

Area Under the curve of time in the hypoglycemic range [Time Frame: End of the study-day 5 of the camp]

Event rate of unanticipated Adverse Device Effects [Time Frame: End of the study-day 5 of the camp]

Incidence of Severe Hypoglycemia [Time Frame: End of study -day 5 of the camp]

Secondary ID(s)

RMC076215ctil

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic