search
Back to results

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
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for type1diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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. Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
  6. Subject uses a rapid-acting analogue insulin in his/her pump
  7. Patient is willing to undergo all study procedures
  8. English proficiency
  9. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

Exclusion:

  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, GLP-1 mimetics, Amylin.
  5. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
  6. Gastroparesis, uncontrolled thyroid disorder, Addison dis. , 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

Sites / Locations

  • Sheba Medical Center

Outcomes

Primary Outcome Measures

Time in ranges

Secondary Outcome Measures

Full Information

First Posted
July 16, 2020
Last Updated
May 9, 2022
Sponsor
Sheba Medical Center
Collaborators
Medtronic
search

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

We'll reach out to this number within 24 hrs