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

Type 2 Diabetes Treated With Insulin Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology 1.5 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. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05785832
Study type Interventional
Source Tandem Diabetes Care, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2023
Completion date September 30, 2024
View Details
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