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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HLCL- Hybrid Logic Closed Loop System
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schneider Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed Loop System

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Event rate of Serious Adverse Events
Event rate of Serious Adverse Device Events
Event rate of unanticipated Adverse Device Effects
Incidence of Diabetic Ketoacidosis
Area under the curve of time in the hyperglycemia range
Area Under the curve of time in the hypoglycemic range
Incidence of Severe Hypoglycemia

Full Information

First Posted
January 7, 2016
Last Updated
December 29, 2019
Sponsor
Rabin Medical Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02651181
Brief Title
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety. The data collected in this study will be used to confirm/develop the HLCL System further. Secondary objectives of this study include evaluation of the HLCL system in a monitored setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy. Run-in Period: A total of up to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar. Study Period - Camp: Following the run-in period subjects will participate in a 5 day, 4 night study period in a camp setting during which the HLCL feature will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HLCL- Hybrid Logic Closed Loop System
Intervention Description
All subjects wearing the HLCL System and using it with the closed loop algorithm
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
Event rate of Serious Adverse Events
Time Frame
End of the study- day 5 of the camp
Title
Event rate of Serious Adverse Device Events
Time Frame
End of the study- day 5 of the camp
Title
Event rate of unanticipated Adverse Device Effects
Time Frame
End of the study-day 5 of the camp
Title
Incidence of Diabetic Ketoacidosis
Time Frame
End of the study-day 5 of the camp
Title
Area under the curve of time in the hyperglycemia range
Time Frame
End of the study-day 5 of the camp
Title
Area Under the curve of time in the hypoglycemic range
Time Frame
End of the study-day 5 of the camp
Title
Incidence of Severe Hypoglycemia
Time Frame
End of study -day 5 of the camp
Other Pre-specified Outcome Measures:
Title
Percentage of time in Closed Loop
Time Frame
End of study -day 5 of the camp
Title
Total insulin dose
Time Frame
End of study-day 5 of the camp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, MD, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Medical Center
City
Petach- Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

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

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