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OpenTrials
Completed

NCT Number: NCT05951569

Loop T2D Observational Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-Derived Open-Source Automated Insulin Delivery Loop System

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • Embecta Medical
  • Tidepool Project

Registry information

Official study title

An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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