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Meal Handling of Advanced Closed Loop Insulin Delivery.

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Advanced hybrid closed loop system
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is 20 to 70 years of age at time of screening
  2. Subject's weight is between 50 and 120 kg
  3. A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
  4. Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening
  5. current use of 670G 4.0 pump
  6. Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
  7. Subject uses a rapid-acting analogue insulin in his/her pump
  8. Patient is willing to undergo all study procedures
  9. English proficiency
  10. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

Exclusion Criteria:

  1. Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
  2. 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)
  3. Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
  4. Subjects currently taking adjunct therapy with SGLT2-inhibitors, Amylin.
  5. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
  6. Gastroparesis, uncontrolled thyroid disorder, Addison disease,. , Pituitary insufficiency
  7. 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
  8. Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
  9. 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
  10. Subject is actively participating in other investigational study (drug or device)
  11. Subjects who consume alcohol daily
  12. Use of CGM (other than per protocol) throughout the duration of the study
  13. Use of Hydroxyurea medication

Sites / Locations

  • Sheba Medical Center

Outcomes

Primary Outcome Measures

Time in range
AUC glucose 300 minutes post meal

Secondary Outcome Measures

Full Information

First Posted
May 24, 2021
Last Updated
May 9, 2022
Sponsor
Sheba Medical Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04901143
Brief Title
Meal Handling of Advanced Closed Loop Insulin Delivery.
Official Title
Meal Handling of Advanced Closed Loop Insulin Delivery.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (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

5. Study Description

Brief Summary
The study will Compare meal related glycemic indices following 2 types of meal announcement: Conventional assessment of carb content plus carb equivalence of proteins and fat Algorithm device optimal universal meal announce equivalent

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
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Advanced hybrid closed loop system
Intervention Description
Phase 1: meals in open loop- 3 weeks Phase 2: closed loop conventional meal announcement- 3 weeks Phase 3: closed loop, pre define universal bolus- 3 weeks
Primary Outcome Measure Information:
Title
Time in range
Description
AUC glucose 300 minutes post meal
Time Frame
300 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 current use of 670G 4.0 pump 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 Criteria: 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, Amylin. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months Gastroparesis, uncontrolled thyroid disorder, Addison disease,. , 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 Use of CGM (other than per protocol) throughout the duration of the study Use of Hydroxyurea medication
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat gan
ZIP/Postal Code
52662
Country
Israel

12. IPD Sharing Statement

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Meal Handling of Advanced Closed Loop Insulin Delivery.

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