NCT05574023

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

Impact of Continuous Glucose Monitoring (CGM) With Predictive Alarm for Hypoglycemia (Guardian Connect System) on Glycemic Control and Hypoglycemia Management in a Group of Adolescents With Type 1 Diabetes Mellitus Treated With Multiple Daily Insulin Injections (MDI).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The use of continuous glucose monitoring (CGM) is becoming the new standard in glycometabolic control in patients with Type 1 Diabetes Mellitus (T1DM) even in subjects in multiple daily insulin injections (MDI). Compared to self-monitoring of blood glucose (SMBG), the CGM systems allow continuous monitoring of the glycemic trends contributing to modify the therapeutic habits of adult and pediatric patients with T1DM and allowing to better managing of critical situations such as hypoglycemia. Recently, the accuracy and reliability performance of the latest generation of CGMs using predictive alarm for hypoglycaemia and hyperglycemia has been compared to other commercially available CGM systems, showing good levels of concordance. The use of this new technology, through the continuous monitoring of the pre-and post-prandial glucose levels and the evaluation of the glycemic trends, could influence the therapeutic habits of patients and could substantially contribute to modifying insulin therapy. Furthermore, the presence of the predictive alarm technology for hypoglycemia could lead to reduce the number of hypoglycemic episodes and to modify the way these hypoglycemic episodes are managed; moreover, the use of this technology could improve the time spent in the target glycemic range \[Time in Range (TIR), 70-180 mg/dl\] with possible improvement also in glycemic variability control.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-03-28
• Completion: 2022-06-10
• First posted: 2022-10-10
• Last updated: 2022-10-10

Locations

1 site across 1 country: Italy