Meal Handling of Advanced Closed Loop Insulin Delivery.

NCT04901143 | Completed

• 1 other identifier: Sheba-21-8159-at-ctil
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in range

  AUC glucose 300 minutes post meal

  300 minutes

Interventions

Advanced hybrid closed loop system DEVICE

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52662, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Amir Tirosh

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 25, 2021
• Study Start: July 17, 2021
• Primary Completion: December 30, 2021
• Study Completion: January 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

IL (1)