Clinical trial NCT04479826: Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Official title: Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: type1diabetes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2020-07-21
Enrollment: 15
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 follow participants for the periods of 3 months while using an advanced hybrid closed loop algorithm in free living conditions . Each period will have a different meal handling protocols. The objective is to identify the mitigation of the algorithm with different meal handling approaches.


Eligibility 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. Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
6. Subject uses a rapid-acting analogue insulin in his/her pump
7. Patient is willing to undergo all study procedures
8. English proficiency
9. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

Exclusion:

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, GLP-1 mimetics, Amylin.
5. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
6. Gastroparesis, uncontrolled thyroid disorder, Addison dis. , 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

Primary outcomes:
measure: Time in ranges
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: