Closed-loop Insulin Delivery for Type 1 Diabetes during Pregnancy

(CIRCUIT Trial)

Recruiting at 13 trial locations

Overseen By Denice Feig, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Must be taking: Insulin therapy

Must not be taking: High dose corticosteroids

Disqualifiers: Non-type 1 diabetes, Nephropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks until delivery of neonate

94 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new insulin pump that automatically adjusts insulin levels for pregnant women with type 1 diabetes. The goal is to see if this pump can better control blood sugar compared to current methods. This could help reduce complications for both mothers and their babies.

Research Team

Denice Feig, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Lois Donovan, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for pregnant women aged 18-45 with type 1 diabetes, who are less than 14 weeks into their pregnancy and have been managing their condition with intensive insulin therapy. Participants should have an A1c level between 6.5% and <10%, be able to use email, and consent to using the study devices throughout the trial. Women with severe diabetes complications or on treatments affecting glucose metabolism cannot join.

Inclusion Criteria

Able to provide informed consent

I have been diagnosed with type 1 diabetes for over a year.

A1c ≥ 6.5% and <10% measured any time during pregnancy prior to enrollment

Exclusion Criteria

Current use of specific insulin management systems

Any reason likely to interfere with the normal conduct of the study and interpretation of study results

I have diabetes, but it's not type 1.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Tandem t:slim X2 insulin pump with Control IQ technology or standard insulin delivery (MDI or pump) with CGM

16 weeks until delivery of neonate

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks postpartum

4 visits (in-person or virtual)

Treatment Details

Interventions

• Tandem t:slim X2 insulin pump with Control IQ technology

Trial Overview The CIRCUIT trial is testing the effectiveness of a Tandem t:slim X2 insulin pump equipped with Control IQ technology in managing blood sugar levels during pregnancy compared to standard insulin delivery plus continuous glucose monitoring (CGM) in women with type 1 diabetes.

Participant Groups

Group I: Tandem t:slim X2 insulin pump with Control IQ technology plus CGM Experimental Treatment 1 Intervention

Participants randomized to the intervention group will be fitted with the Tandem t:slim X2 insulin pump with Control IQ technology and Dexcom G6 Continuous Glucose Monitor.

Group II: Standard insulin delivery (multiple daily injections (MDI) or pump) and CGM Active Control 1 Intervention

Participants randomized to the control group will be fitted with the Dexcom G6 Continuous Glucose Monitor. They will continue to use standard insulin delivery (MDI or pump) and CGM.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+