- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479826
Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
May 9, 2022 updated by: Prof. Amir Tirosh, Sheba Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel-Hashomer, Israel
- Sheba Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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
- 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
Exclusion:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time in ranges
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2020
Primary Completion (Actual)
July 16, 2021
Study Completion (Actual)
July 16, 2021
Study Registration Dates
First Submitted
July 16, 2020
First Submitted That Met QC Criteria
July 16, 2020
First Posted (Actual)
July 21, 2020
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sheba-19-5955-at-ctil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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