Status:
COMPLETED
Closed-loop Insulin Delivery In Type 1 Diabetes Pregnancies (CIRCUIT)
Lead Sponsor:
University of Calgary
Conditions:
Type 1 Diabetes Mellitus
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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.
Detailed 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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Non-type 1 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- Known or suspected allergy to insulin
- 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
- Total daily insulin dose \<8 or \>250 units/day at screening
- Severe visual or hearing impairment, as judged by the investigator to impact treatment 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, 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
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04902378
Start Date
June 15 2021
End Date
May 23 2025
Last Update
June 5 2025
Active Locations (14)
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1
Campbelltown Hospital
Campbelltown, Australia, 2560
2
Royal Prince Alfred Hospital
Camperdown, Australia
3
Canberra Hospital
Garran, Australia
4
Royal Women's Hospital
Parkville, Australia