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
- Diseases
- Type 1 diabetes
- 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
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campbelltown Hospital Coordinator of this site? Confirm its status | Campbelltown | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Canberra Hospital Coordinator of this site? Confirm its status | Garran | Australia | Unknown status |
| Royal Women's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| LAWSON Health Research Institute Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| University of Montreal - CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sunnybrook Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Women's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.