NCT05422053

Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate \> 3 units/hr.

Detailed description

The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate \> 3 units/hr. Up to 60 participants may be recruited.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	t:slim X2 insulin pump with Control-IQ technology 1.5	t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2022-06-16
• Last updated: 2025-04-03
• Results posted: 2024-04-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study