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NCT04902378Completed

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

Closed-loop Insulin Delivery by Glucose Responsive Computer Algorithms In Type 1 Diabetes Pregnancies (CIRCUIT)

Source: ClinicalTrials.gov · Last updated 5 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
94 (actual)
First submitted
28 Apr 2021
Start date
15 Jun 2021
Primary completion date
23 May 2025
Lead sponsor
University of Calgary
NCT number
NCT04902378

What you commit to

  • Study type: Interventional
  • Participants enrolled: 94
  • From 15 Jun 2021 to the primary completion date, 23 May 2025
  • 14 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Non-type 1 diabetes
  • Known or suspected allergy to insulin
  • Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance

Lab values

  • Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
  • Women with nephropathy (estimated glomerular filtration rate \[eGFR\] \<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results

Other

  • Total daily insulin dose \<8 or \>250 units/day at screening
  • 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, or alternate closed-loop system as judged by the investigator
  • Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results

Who the study is looking for

  • Between 18 and 45 years of age (inclusive)
  • A diagnosis of type 1 diabetes, as defined by Diabetes Canada, for at least 12 months
  • A viable singleton pregnancy confirmed by ultrasound, less than 14 weeks gestation
  • Currently on intensive insulin therapy (≥ 3 injections, or Continuous subcutaneous insulin 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

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Campbelltown Hospital
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CampbelltownAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Canberra Hospital
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GarranAustraliaUnknown status
Royal Women's Hospital
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ParkvilleAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
IWK Health Centre
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HalifaxCanadaUnknown status
LAWSON Health Research Institute
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LondonCanadaUnknown status
University of Montreal - CHUM
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MontrealCanadaUnknown status
Universite Laval
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QuébecCanadaUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
Sunnybrook
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TorontoCanadaUnknown status
BC Women's Hospital
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VancouverCanadaUnknown status
University of Manitoba
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WinnipegCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.