Effect of CGM With Predictive Alarm on Hypoglycemia in Young Patients With T1D.

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

March 28, 2022

Study Completion Date

June 10, 2022

Conditions
Type 1 Diabetes
Interventions
DEVICE

Use of Predictive Alarm for hypoglycaemia or hyperglycaemia

"Patients use CGM sensor with Predictive Alarm set at 70 mg/dl in 20 minutes for hypoglycemia and at 250 mg/dl in 20 minutes for hyperglycemia.~1. in case of alarm from the hypoglycemia predictive algorithm, the indicated treatment was 0.1g of sugar/kg of body weight;~2. in case of alarm from the hyperglycemia predictive algorithm, the indication was to give an extra shot of rapid-acting insulin. The dose will be calculated on the basis of personal insulin sensitivity factor (ISF), considering as target a blood glucose of 120 mg/dl and 250 mg/dl as the projected blood glucose level that will be reached in 20 minutes. This could be done only if there is no active insulin on-board, after at least 3 hours from the last rapid-acting insulin injection."

DEVICE

Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia

"in case of alarm of hypoglycemia, the indicated treatment was 0.3g of sugar/kg of body weight, max 15g.~in case of alarm of hyperglycemia, the indication will be to give an extra shot of rapid-acting insulin. The dose will be calculated on the basis of personal insulin sensitivity factor (ISF), considering as target a blood glucose of 120 mg/dl and 250 mg/dl as blood glucose level to correct. This could be done only if there is no active insulin on-board, after at least 3 hours from the last rapid-acting insulin injection."

Trial Locations (1)

37126

Pediatric Diabetes and Metabolic Disorders Unit, Surgery, Dentistry, Paediatrics and Gynaecology, University of Verona, 1 Piazzale Stefani, Verona

All Listed Sponsors
lead

Azienda Ospedaliera Universitaria Integrata Verona

OTHER