Clinical trial NCT04901143: Meal Handling of Advanced Closed Loop Insulin Delivery.
Official title: Meal Handling of Advanced Closed Loop Insulin Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2021-05-25
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time in range
timeFrame: 300 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: