Loop T2D Observational Study
October 10, 2023 updated by: Jaeb Center for Health Research
An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys.
Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
Study Type
Observational
Enrollment (Actual)
8
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
-
-
Florida
-
Tampa, Florida, United States, 33647
- Jaeb Center for Health Research
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.
Description
Inclusion Criteria:
- Type 2 diabetes
- Age ≥18 years old
- Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days
- Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol
- Resident of the US
- English speaking/reading
- Access to email/phone
Exclusion Criteria:
- None
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
Time Frame: Up to 3 months
|
Number of DKA events and event outcomes.
DKA events are defined as hospitalization with documentation of arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate (or CO2) <15.
|
Up to 3 months
|
|
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
Time Frame: Up to 3 months
|
Number of severe hypoglycemic events and event outcomes.
Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else.
The individual may or may not have lost consciousness.
|
Up to 3 months
|
|
Measure of Loop Safety by Self-Report of Hospitalization Events
Time Frame: Up to 3 months
|
Number of hospitalizations
|
Up to 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loop T2D Baseline General Data Collection
Time Frame: Enrollment
|
Self-report participant's basic information.
No scale provided, variable responses.
|
Enrollment
|
|
Loop T2D Follow-up Survey
Time Frame: Monthly up to 3 months
|
Self-report of participant's use of Loop and Loop related features.
No scale provided, variable responses.
|
Monthly up to 3 months
|
|
HbA1c
Time Frame: Enrollment, Monthly up to 3 months
|
Self-report
|
Enrollment, Monthly up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colleen Bauza, PhD, MPH, Jaeb Center for Health Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 20, 2023
Primary Completion (Actual)
September 8, 2023
Study Completion (Actual)
September 8, 2023
Study Registration Dates
First Submitted
July 11, 2023
First Submitted That Met QC Criteria
July 11, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T2D Loop
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.