Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes (DREAMED)
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hybrid-logic closed loop system
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Diabetes duration > 1 year since diagnosis
- Sensor augmented Pump for at least 6 months
- Age 18-25
- 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 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 POC 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hybrid-logic closed loop system
Arm Description
All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump.
Outcomes
Primary Outcome Measures
Descriptive endpoints
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
Secondary Outcome Measures
Descriptive endpoints
Serious Adverse Events (SAE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02692547
Brief Title
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Acronym
DREAMED
Official Title
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study Cancelled
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Detailed Description
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 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (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 an camp setting during which the CL feature will be studied.
Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates.
Subjects will be asked to exercise for up to 60 minutes on one day during their study period.
Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)
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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid-logic closed loop system
Arm Type
Other
Arm Description
All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump.
Intervention Type
Device
Intervention Name(s)
Hybrid-logic closed loop system
Intervention Description
All patients get to wear the pump
Primary Outcome Measure Information:
Title
Descriptive endpoints
Description
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
Time Frame
after 4 days of camp
Secondary Outcome Measure Information:
Title
Descriptive endpoints
Description
Serious Adverse Events (SAE)
Time Frame
after 4 days of camp
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes duration > 1 year since diagnosis
Sensor augmented Pump for at least 6 months
Age 18-25
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 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 POC 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Philip, MD
Organizational Affiliation
National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
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