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Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition

Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04479826
Enrollment
15
Registered
2020-07-21
Start date
2020-07-16
Completion date
2021-07-16
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type1diabetes

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.

Interventions

Free living follow-up of meal handelling

Sponsors

Medtronic
CollaboratorINDUSTRY
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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. 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

Design outcomes

Primary

MeasureTime frame
Time in ranges3 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026