Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Primary Purpose
type1diabetes
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Advanced hybrid closed loop system
Sponsored by
About this trial
This is an interventional treatment trial for type1diabetes
Eligibility Criteria
- Subject is 20 to 70 years of age at time of screening
- Subject's weight is between 50 and 120 kg
- A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
- Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening
- Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
- Subject uses a rapid-acting analogue insulin in his/her pump
- Patient is willing to undergo all study procedures
- English proficiency
- Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
Exclusion:
- Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
- Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
- Subjects currently taking adjunct therapy with SGLT2-inhibitors, GLP-1 mimetics, Amylin.
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
- Gastroparesis, uncontrolled thyroid disorder, Addison dis. , Pituitary insufficiency
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
- Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
- Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
- Subject is actively participating in other investigational study (drug or device)
- Subjects who consume alcohol daily
Sites / Locations
- Sheba Medical Center
Outcomes
Primary Outcome Measures
Time in ranges
Secondary Outcome Measures
Full Information
NCT ID
NCT04479826
First Posted
July 16, 2020
Last Updated
May 9, 2022
Sponsor
Sheba Medical Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT04479826
Brief Title
Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Official Title
Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will follow participants for the periods of 3 months while using an advanced hybrid closed loop algorithm in free living conditions . Each period will have a different meal handling protocols. The objective is to identify the mitigation of the algorithm with different meal handling approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Advanced hybrid closed loop system
Intervention Description
Free living follow-up of meal handelling
Primary Outcome Measure Information:
Title
Time in ranges
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject is 20 to 70 years of age at time of screening
Subject's weight is between 50 and 120 kg
A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening
Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
Subject uses a rapid-acting analogue insulin in his/her pump
Patient is willing to undergo all study procedures
English proficiency
Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
Exclusion:
Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
Subjects currently taking adjunct therapy with SGLT2-inhibitors, GLP-1 mimetics, Amylin.
Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
Gastroparesis, uncontrolled thyroid disorder, Addison dis. , Pituitary insufficiency
Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
Subject is actively participating in other investigational study (drug or device)
Subjects who consume alcohol daily
Facility Information:
Facility Name
Sheba Medical Center
City
Tel-Hashomer
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
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