Clinical trial NCT05951569: Loop T2D Observational Study
Official title: An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Loop
Type 2 Diabetes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Embecta Medical
name: Tidepool Project
First posted: 2023-07-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.

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.

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.

Eligibility 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

Primary outcomes:
measure: Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
timeFrame: Up to 3 months
measure: Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
timeFrame: Up to 3 months
measure: Measure of Loop Safety by Self-Report of Hospitalization Events
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
measure: Loop T2D Baseline General Data Collection
timeFrame: Enrollment
measure: Loop T2D Follow-up Survey
timeFrame: Monthly up to 3 months
measure: HbA1c
timeFrame: Enrollment, Monthly up to 3 months
Locations:
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
Study officials:
affiliation: Jaeb Center for Health Research
name: Colleen Bauza, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, Arbiter B, Brown AS, DeSalvo DJ, Pettus J, Calhoun P, Beck RW. A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther. 2021 May;23(5):367-375. doi: 10.1089/dia.2020.0535. Epub 2021 Apr 12.