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

  • United States
    • 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

Jaeb Center for Health Research

Collaborators

Tidepool Project
Embecta Medical

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.

General Publications

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.

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