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Loop T2D Observational Study

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ClinicalTrials.gov Identifier: NCT05951569
Recruitment Status : Completed
First Posted : July 19, 2023
Last Update Posted : October 12, 2023
Sponsor:
Collaborators:
Embecta Medical
Tidepool Project
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Device: Community-Derived Open-Source Automated Insulin Delivery Loop System

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 Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
Actual Study Start Date : June 20, 2023
Actual Primary Completion Date : September 8, 2023
Actual Study Completion Date : September 8, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Community-Derived Open-Source Automated Insulin Delivery Loop System
    The Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Measure of Loop Safety by Self-Report of Hospitalization Events [ Time Frame: Up to 3 months ]
    Number of hospitalizations


Other Outcome Measures:
  1. Loop T2D Baseline General Data Collection [ Time Frame: Enrollment ]
    Self-report participant's basic information. No scale provided, variable responses.

  2. 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.

  3. HbA1c [ Time Frame: Enrollment, Monthly up to 3 months ]
    Self-report


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951569


Locations
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United States, Florida
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Sponsors and Collaborators
Jaeb Center for Health Research
Embecta Medical
Tidepool Project
Investigators
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Principal Investigator: Colleen Bauza, PhD, MPH Jaeb Center for Health Research
More Information
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Publications of Results:

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT05951569    
Other Study ID Numbers: T2D Loop
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaeb Center for Health Research:
Loop
Type 2 Diabetes
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs