Loop T2D Observational Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951569
• Other study ID #: T2D Loop
• Status: Completed
• Start date: June 20, 2023
• Est. completion date: September 8, 2023

Study information

• Verified date: July 2023
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Embecta Medical, Tidepool Project

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Diabete — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loop T2D Baseline General Data Collection	Self-report participant's basic information. No scale provided, variable responses.	Enrollment
Other	Loop T2D Follow-up Survey	Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses.	Monthly up to 3 months
Other	HbA1c	Self-report	Enrollment, Monthly up to 3 months
Primary	Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events	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
Primary	Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events	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
Primary	Measure of Loop Safety by Self-Report of Hospitalization Events	Number of hospitalizations	Up to 3 months