NCT05951569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
Last Updated

October 12, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 11, 2023

Last Update Submit

October 10, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

LoopType 2 DiabetesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Measure of Loop Safety by Self-Report of Hospitalization Events

    Number of hospitalizations

    Up to 3 months

Other Outcomes (3)

  • Loop T2D Baseline General Data Collection

    Enrollment

  • Loop T2D Follow-up Survey

    Monthly up to 3 months

  • HbA1c

    Enrollment, Monthly up to 3 months

Interventions

Community-Derived Open-Source Automated Insulin Delivery Loop SystemDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Related Publications (2)

  • 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.

    PMID: 33226840RESULT

  • Bauza C, Kanapka LG, Greene E, Lal RA, Arbiter B, Beck RW. Use of the Community-Derived Open-Source Automated Insulin Delivery Loop System in Type 2 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):494-497. doi: 10.1089/dia.2023.0569. Epub 2024 Apr 8.

    PMID: 38386434DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Colleen Bauza, PhD, MPH

    Jaeb Center for Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

June 20, 2023

Primary Completion

September 8, 2023

Study Completion

September 8, 2023

Last Updated

October 12, 2023

Record last verified: 2023-07

Locations

US(1)