What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes include multiple daily injections (MDI) of insulin and the use of insulin pumps, often combined with continuous glucose monitoring (CGM) systems. Automated insulin delivery systems, such as the Tandem t:slim X2 insulin pump with Control IQ technology, use CGM data to adjust insulin delivery. Known side effects of these treatments can include hypoglycemia, hyperglycemia, skin irritation or infection at the infusion site, and the potential for diabetic ketoacidosis if the pump malfunctions. Additionally, users may experience challenges related to the complexity and maintenance of the devices.

What prior FDA approvals exist?

The FDA has approved several advanced insulin delivery systems for the treatment of Type 1 Diabetes, focusing on automated insulin delivery based on continuous glucose monitoring (CGM) data. Notable approvals include the Medtronic MiniMed 670G system, which was the first hybrid closed-loop system approved in 2016. This system automatically adjusts basal insulin delivery based on CGM readings. Another significant approval is the Tandem t:slim X2 insulin pump with Control-IQ technology, which was approved in 2019. This system uses an advanced algorithm to adjust insulin delivery based on CGM data, aiming to improve glycemic control and reduce the burden of diabetes management.

What other types of research exist?

Promising alternatives to the Tandem t:slim X2 insulin pump with Control IQ technology for Type 1 Diabetes patients include the Medtronic hybrid closed-loop system with the proportional-integral-derivative with insulin feedback (PID-IFB) algorithm, as it has been tested in both adults and adolescents and shown to improve time in range. Another option is the Minimed 670G hybrid closed-loop system, which has been used to improve glucose control and quality of life in patients.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-13 weeks + 6 days gestation, 24 weeks gestation, 34 weeks gestation, 6 weeks postpartum

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met

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.