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Insulin Delivery Device

Closed-loop Insulin Delivery for Type 1 Diabetes during Pregnancy (CIRCUIT Trial)

N/A
Waitlist Available
Led By Lois Donovan, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 45 years of age (inclusive)
Diagnosis of type 1 diabetes for at least 12 months as defined by Diabetes Canada
Must not have
Non-type 1 diabetes
Total daily insulin dose <8 or >250 units/day at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-13 weeks + 6 days gestation until delivery of neonate
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include skin irritation at the infusion site, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), or allergic reactions to components of the pump system. The device's automated features could also malfunction leading to incorrect insulin dosing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I have been diagnosed with type 1 diabetes for over a year.
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I use intensive insulin therapy, either through injections or a pump.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes, but it's not type 1.
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My daily insulin dose is either less than 8 units or more than 250 units.
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I cannot effectively communicate in English or French.
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I am not taking high dose steroids or medications that affect blood sugar.
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I am a woman with severe kidney issues, nerve damage, uncontrolled stomach paralysis, or advanced eye disease due to diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glycemic control as reflected by percent glucose time-in-range
Secondary study objectives
Diabetes-related distress to the participant
Complications of Diabetes Mellitus
Fear of hyperglycemia
+18 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tandem t:slim X2 insulin pump with Control IQ technology plus CGMExperimental Treatment1 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 CGMActive Control1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Type 1 Diabetes is insulin therapy, which involves administering insulin to manage blood glucose levels. Automated insulin delivery systems, such as the Tandem t:slim X2 insulin pump with Control IQ technology, use continuous glucose monitoring (CGM) data to automatically adjust insulin delivery. This technology mimics the body's natural insulin response, providing more precise and timely insulin administration. For Type 1 Diabetes patients, this results in better glycemic control, reduced risk of hypoglycemia and hyperglycemia, and overall improved quality of life by minimizing the burden of constant blood glucose monitoring and manual insulin adjustments.
Assessing the effectiveness of a 3-month day-and-night home closed-loop control combined with pump suspend feature compared with sensor-augmented pump therapy in youths and adults with suboptimally controlled type 1 diabetes: a randomised parallel study protocol.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
806 Previous Clinical Trials
883,978 Total Patients Enrolled
Lois Donovan, MDPrincipal InvestigatorUniversity of Calgary
Denice Feig, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
4 Previous Clinical Trials
1,332 Total Patients Enrolled

Media Library

Tandem t:slim X2 insulin pump with Control IQ technology (Insulin Delivery Device) Clinical Trial Eligibility Overview. Trial Name: NCT04902378 — N/A
Type 1 Diabetes Research Study Groups: Tandem t:slim X2 insulin pump with Control IQ technology plus CGM, Standard insulin delivery (multiple daily injections (MDI) or pump) and CGM
Type 1 Diabetes Clinical Trial 2023: Tandem t:slim X2 insulin pump with Control IQ technology Highlights & Side Effects. Trial Name: NCT04902378 — N/A
Tandem t:slim X2 insulin pump with Control IQ technology (Insulin Delivery Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902378 — N/A
~4 spots leftby Jan 2025