Meal Handling of Advanced Closed Loop Insulin Delivery.

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04901143
• Collaborator: Medtronic (Industry)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Device: Advanced hybrid closed loop system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Meal Handling of Advanced Closed Loop Insulin Delivery.
• Actual Study Start Date: Jul 17, 2021
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Jan 1, 2022

Outcome Measures

Primary Outcome Measures

1. Time in range [300 minutes]

   AUC glucose 300 minutes post meal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat gan		Israel	52662

Sponsors and Collaborators

• Sheba Medical Center
• Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Amir Tirosh, Prof. Amir Tirosh, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT04901143
• Other Study ID Numbers: Sheba-21-8159-at-ctil
• First Posted: May 25, 2021
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1

Study Results

No Results Posted as of May 12, 2022