Meal Handling of Advanced Closed Loop Insulin Delivery.

May 9, 2022 updated by: Prof. Amir Tirosh, Sheba Medical Center

The study will Compare meal related glycemic indices following 2 types of meal announcement:

  1. Conventional assessment of carb content plus carb equivalence of proteins and fat
  2. Algorithm device optimal universal meal announce equivalent

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat gan, Israel, 52662
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 300 minutes
AUC glucose 300 minutes post meal
300 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sheba-21-8159-at-ctil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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