Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)

Last updated: August 13, 2024
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Treatment

Tandem t:slim X2 insulin pump with Control IQ technology

Clinical Study ID

NCT04902378
REB20-1266
  • Ages 18-45
  • Female

Study Summary

This trial will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant women with type 1 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 18 and 45 years of age (inclusive)

  • A diagnosis of type 1 diabetes, as defined by Diabetes Canada, for at least 12months

  • A viable singleton pregnancy confirmed by ultrasound, less than 14 weeks gestation

  • Currently on intensive insulin therapy (≥ 3 injections, or Continuous subcutaneousinsulin infusion (CSII)

  • Willingness to use the study devices throughout the trial

  • A1c ≥ 6.2% and <10% measured any time during pregnancy prior to enrollment

  • Able to provide informed consent

  • Have access to email

Exclusion

Exclusion Criteria:

  • Non-type 1 diabetes

  • Current treatment with drugs known to interfere with glucose metabolism as judged bythe investigator such as high dose systemic corticosteroids

  • Known or suspected allergy to insulin

  • Women with nephropathy (estimated glomerular filtration rate [eGFR] <45), severeautonomic neuropathy, uncontrolled gastroparesis or severe proliferativeretinopathy, as judged by the investigator, that is likely to interfere with thenormal conduct of the study and interpretation of study results

  • Total daily insulin dose <8 or >250 units/day at screening

  • Severe visual or hearing impairment, as judged by the investigator to impacttreatment compliance

  • Unable to communicate effectively in English or French as judged by the investigator

  • Current use of Tandem Control IQ, DIY looping system, 670G in Auto Mode, oralternate closed-loop system as judged by the investigator

  • Any reason judged by the investigator that would likely interfere with the normalconduct of the study and interpretation of study results

Study Design

Total Participants: 94
Treatment Group(s): 1
Primary Treatment: Tandem t:slim X2 insulin pump with Control IQ technology
Phase:
Study Start date:
June 15, 2021
Estimated Completion Date:
March 21, 2025

Study Description

Pregnant women with type 1 diabetes (T1D) require normal or near normal glucose in order to reduce the risks of birth defects, stillbirth, increased birthweight, neonatal hypoglycemia, neonatal death, preterm delivery and preeclampsia. Reducing maternal glucose is extremely difficult due to an increased risk of maternal hypoglycemia. Only 14% of T1D pregnancies achieve pregnancy guideline recommended glucose control, leading to complications related to high maternal glucose exposure in roughly half of newborns.

Maintaining recommended maternal glucose levels during pregnancy reduces the risk of adverse neonatal outcomes to those similar in pregnancies unaffected by T1D. Most insulin pumps in use today are open-loop systems, which means that the user must program the pump to deliver a pre-set amount of insulin. These insulin delivery methods (MDI and open-loop pumps) are usually inadequate to achieve the optimal glucose control necessary for T1D pregnancies and they impart a large time, effort and emotional burden.

Closed-loop systems have been found to be effective in improving glucose control outside of pregnancy when studied in children and adults. A new hybrid closed-loop system, the Tandem t:slim X2 insulin pump with Control IQ technology, recently became commercially available. Trials have demonstrated the efficacy of the Control IQ algorithm for non-pregnant adults and children. Pregnant women were not included in these trials.

The investigators propose the first randomized controlled trial to evaluate the Tandem t:slim X2 insulin pump with Control IQ technology versus standard insulin delivery (MDI or pump) and CGM in pregnant women with T1D. In this trial, the investigators will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant women with type 1 diabetes.

We are grateful to Tandem Diabetes Care and Dexcom for in-kind donations to this investigator initiated study.

Connect with a study center

  • Campbelltown Hospital

    Campbelltown, 2560
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown,
    Australia

    Site Not Available

  • Canberra Hospital

    Garran,
    Australia

    Site Not Available

  • Royal Women's Hospital

    Parkville,
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead,
    Australia

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2T 5C7
    Canada

    Site Not Available

  • BC Women's Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6C 2R5
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5T 3L9
    Canada

    Site Not Available

  • Sunnybrook

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University of Montreal - CHUM

    Montréal, Quebec H2X 3J4
    Canada

    Site Not Available

  • Université Laval

    Quebec City, Quebec G1V 4G2
    Canada

    Site Not Available

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