34
Participants
Start Date
November 21, 2021
Primary Completion Date
June 30, 2022
Study Completion Date
August 31, 2022
Regular Protocol with advanced carbohydrate counting
"* Review 3 Days CGM data in Manual Mode~* Carb Ratio by formula 360 / TDD~* Finetune ICR~* Target 100 or 110 mg/dl~* AIT: 2-3 hour~* Insulin Bolus for meal (advanced carb counting)~* The parameters will be set using clinical assessment and fine-tuned if needed on F-up visits.~* Follow up visits will be scheduled Day 7, 14,28, 56 and 84 after enabling SmartGuard (AHCL use)."
Simplified Protocol with fixed carbohydrate content
"* Review 3 Days CGM data in Manual Mode~* Carb Ratio by formula 360 / TDD ICR 8-10 (TDD 40-60) ICR 5-7 (TDD \>60)~* Target 100 mg/dl~* AIT: 2 hours~* Insulin Bolus for meal (Thee sets of meal set of meals announcement carbs will be provided) Regular meal: Total Carbs per Day x 0.6 / 3 Large meal: Total Carbs per Day x 0.6 / 3 x 1.5 Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5~* Total carbs per day will be calculated as average on 7-days Food Logbook diary, provided by participant, one week before AHCL initiation.~* The parameters will be fixed and fine-tuned only in case of hypoglycemia on F-up visits."
Sidra Medicine, Doha
Sidra Medicine
OTHER