Meal Handling of Advanced Closed Loop Insulin Delivery.

NCT ID: NCT04901143

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-17
• Study Completion Date: 2022-01-01

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

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Advanced hybrid closed loop system

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Amir Tirosh

Prof. Amir Tirosh

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

Sheba-21-8159-at-ctil

Identifier Type: -

Identifier Source: org_study_id