NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems

Korábbi kezelés

• Anticipated therapeutic change (including change of CGM sensor [other than Dexcom sensors] or AID system type, new antidiabetic drug initiation) between admission and end of the study
• Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment).

Más betegség

• Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
• Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
• Known or suspected allergies to study products (e.g., Dexcom adhesive)
• Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator

Laborértékek

• Participant-reported clinically significant nephropathy (eGFR < 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator

Egyéb

• Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
• % of time spent out of automated mode exceeding 10% in last month's trial start
• Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings)
• Pregnancy (ongoing or current attempt to become pregnant)
• Breastfeeding
• Plan to go abroad in a foreign country during the study period
• Severe hypoglycemic episode within one month of screening
• Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months
• Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)
• Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)
• In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device.

• Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)
• Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
• Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM.
• If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage).
• Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period.