Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2020
CompletedStudy Start
First participant enrolled
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2021
CompletedMay 12, 2022
May 1, 2022
1 year
July 16, 2020
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time in ranges
3 months
Interventions
Free living follow-up of meal handelling
Eligibility Criteria
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, GLP-1 mimetics, Amylin.
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
- Gastroparesis, uncontrolled thyroid disorder, Addison dis. , 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Medtroniccollaborator
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, Israel
Related Publications (1)
Shalit R, Minsky N, Laron-Hirsh M, Cohen O, Kurtz N, Roy A, Grosman B, Benedetti A, Tirosh A. Unannounced Meal Challenges Using an Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2023 Sep;25(9):579-588. doi: 10.1089/dia.2023.0139.
PMID: 37335759DERIVED
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
- Clinical Professor
Study Record Dates
First Submitted
July 16, 2020
First Posted
July 21, 2020
Study Start
July 16, 2020
Primary Completion
July 16, 2021
Study Completion
July 16, 2021
Last Updated
May 12, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share