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

Más betegség

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

Laborértékek

• 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

Egyéb

• 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

• 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