Trials / Completed
CompletedNCT05111301
Control-IQ Technology in Individuals With Type 2 Diabetes
Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Tandem Diabetes Care, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
Detailed description
The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Control-IQ technology 1.5 | All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level. |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2022-08-10
- Completion
- 2022-08-18
- First posted
- 2021-11-08
- Last updated
- 2024-03-06
- Results posted
- 2024-03-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05111301. Inclusion in this directory is not an endorsement.