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Insulin Delivery Device

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

Q: What is the total capacity of participants for this medical experiment?

Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which was first posted on June 15th 2021, is presently recruiting participants. 66 patients are required from two sites.

Q: Are any additional participants being welcomed into this clinical trial at present?

Affirmative. As indicated by clinicaltrials.gov, this experiment is recruiting volunteers at the present time. The trial was initially posted on June 15th 2021 and freshly modified on August 4th 2022; it requires 66 participants from 2 distinct sites to take part in the research.

Q: Does this investigation permit individuals above the age of sixty to enroll?

Per the clinical trial's eligibility criteria, individuals between 18 and 45 years old are qualified to apply. Additionally, there exists 286 trials accepting minors as participants while 1100 studies target senior citizens who exceed 65 years of age.

Q: Can I join this clinical research project given my circumstances?

This clinical trial requires 66 participants with glucose metabolism issues who are between 18 and 45 years old. In addition, they must meet the following conditions: willingness to use assigned devices during the course of study, A1c ≥ 6.5% on a pre-enrollment blood test, have given informed consent prior to enrolment, possess email access , <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> diagnosis according to Diabetes Canada standards for at least 12 months, regular insulin treatment (either 3 injections or Continuous subcutaneous infusion therapy), singleton <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> confirmed by ultrasound below 14 weeks gestation.

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CIRCUIT Trial Summary

This trial will assess how well the Tandem t:slim X2 insulin pump with Control IQ technology works compared to standard insulin delivery plus a continuous glucose monitor (CGM) in pregnant women with type 1 diabetes.

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.Check my eligibility

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.See study design

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.

CIRCUIT Trial 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.

CIRCUIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycemic control as reflected by percent glucose time-in-range

Secondary outcome measures

Comparison of birthweight z-score

Diabetes-related distress to the participant

Complications of Diabetes Mellitus

+24 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241

21%

Hypoglycemia

100%

80%

60%

40%

20%

Study treatment Arm

NPH With Corticosteroid

Control

CIRCUIT 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,064 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total capacity of participants for this medical experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which was first posted on June 15th 2021, is presently recruiting participants. 66 patients are required from two sites."

Answered by AI

Are any additional participants being welcomed into this clinical trial at present?

"Affirmative. As indicated by clinicaltrials.gov, this experiment is recruiting volunteers at the present time. The trial was initially posted on June 15th 2021 and freshly modified on August 4th 2022; it requires 66 participants from 2 distinct sites to take part in the research."

Answered by AI

Does this investigation permit individuals above the age of sixty to enroll?

"Per the clinical trial's eligibility criteria, individuals between 18 and 45 years old are qualified to apply. Additionally, there exists 286 trials accepting minors as participants while 1100 studies target senior citizens who exceed 65 years of age."

Answered by AI

Can I join this clinical research project given my circumstances?

"This clinical trial requires 66 participants with glucose metabolism issues who are between 18 and 45 years old. In addition, they must meet the following conditions: willingness to use assigned devices during the course of study, A1c ≥ 6.5% on a pre-enrollment blood test, have given informed consent prior to enrolment, possess email access , type 1 diabetes diagnosis according to Diabetes Canada standards for at least 12 months, regular insulin treatment (either 3 injections or Continuous subcutaneous infusion therapy), singleton pregnancy confirmed by ultrasound below 14 weeks gestation."

Answered by AI