Simple Initiation of Advanced Hybrid Closed Loop System

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 21, 2021

Primary Completion Date

June 30, 2022

Study Completion Date

August 31, 2022

Conditions
Diabetes type1
Interventions
PROCEDURE

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)."

PROCEDURE

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."

Trial Locations (1)

26999

Sidra Medicine, Doha

All Listed Sponsors
lead

Sidra Medicine

OTHER

NCT05069727 - Simple Initiation of Advanced Hybrid Closed Loop System | Biotech Hunter | Biotech Hunter