NCT05785832

A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes

A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy.

Detailed description

A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ+ technology in adults with type 2 diabetes age 18 and older using basal-bolus insulin therapy compared with continuation of pre-study insulin delivery plus continuous glucose monitoring (CGM). At least 300 participants will complete the trial at up to 25 clinical sites, across the United States and Canada. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the intervention group using the t:slim X2 insulin pump with Control-IQ+ technology or to continue their pretrial insulin-delivery method for 13 weeks. Both arms used the Dexcom G6 CGM. The primary outcome is change in hemoglobin A1c (HbA1c) compared between the intervention and control group. The secondary endpoints will be tested for superiority, with a hierarchical testing approach. Additional outcomes are exploratory.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DEVICE	t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM	The t:slim X2 insulin pump with Control-IQ+ technology, used with the Dexcom G6 CGM.
DEVICE	Standard Therapy plus continuous glucose monitoring (CGM)	Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2023-03-27
• Last updated: 2026-02-19
• Results posted: 2025-06-03

Locations

21 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study