Control-IQ Technology for Type 2 Diabetes
(2IQP Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tandem Diabetes Care, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with type 2 diabetes in the U.S. or Canada, using basal-bolus insulin therapy for at least 3 months without recent changes. Participants must not start new glucose-lowering meds during the trial, change doses of current meds unless necessary, use concentrated or inhaled insulin, and must be able to complete study visits and tasks.

Inclusion Criteria

I am willing to follow the study's diet and exercise plan and have someone to help me if my blood sugar gets too low.

I understand the details of the clinical trial and can make informed decisions.

I am using birth control that contains progestogen only.

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Exclusion Criteria

I am not using and do not plan to use steroid pills or injections during the trial.

I am currently taking sulfonylurea or meglitinide medications.

You have a condition that may make it difficult to measure your HbA1c levels accurately.

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Treatment Details

Interventions

Standard Therapy plus continuous glucose monitoring (CGM) (Device)
t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM (Insulin Pump)

Trial OverviewThe trial is testing Control-IQ technology which includes a t:slim X2 insulin pump paired with Dexcom G6 CGM against standard therapy plus CGM alone. The goal is to see if this tech can better manage blood sugar levels in adults with type 2 diabetes on insulin therapy.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the Intervention group using t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM for 13 weeks.

Group II: Control groupActive Control1 Intervention

Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6).