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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia; Device: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia

• Registration Number: NCT05574023
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Primary Completion: 2022-03-28
• Study Completion: 2022-06-10
• Status Verified: 2022-07
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Last Update Submitted: 2022-10-07
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• T1DM for at least 12 months [assessed by positivity of at least one of the antibodies against islet cells (ICA), insulin (IAA), glutamate dehydroxylase (GADA), islet antigen 2 (IA2A), or Zinc Transporter 8 Antibodies (ZnT8)];
• MDI therapy from at least 6 months with basal-bolus treatment (long acting insulin analog plus rapid acting insulin analogue);
• HbA1c < 9.0%
• normal weight (BMI <85th percentile for age and gender);
• no other chronic diseases (thyroiditis, celiac disease, etc) or eating behavior disorders (DCA);
• signed informed consent from parents or legal guardians and patients (<18 y).

Exclusion Criteria

• T1DM for less than 12 months;
• CSII therapy
• Previous usage of CGM with predictive alarm for hypoglycemia or hyperglycemia
• MDI therapy from less than 6 months
• use of regular insulin instead of rapid acting insulin analogue;
• other chronic diseases (thyroiditis, celiac disease, etc.) or eating behavior disorders (DCA).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Predictive Alarm (PA)	Use of Predictive Alarm for hypoglycaemia or hyperglycaemia	Patients use the CGM sensor with Predictive Alarm on set at 70 mg/dl in 20 minutes for hypoglycemia and at 250 mg/dl in 20 minutes for hyperglycemia.
Alarm on Threshold (AoT)	Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia	Patients use the CGM sensor with alarms on a threshold of 70 mg/dl for hypoglycemia and 250 mg/dl for hyperglycemia.

Primary Outcome Measures

Name	Time	Method
Less time spent in hypoglycaemia using Predictive Alarm vs Alarm on Threshold	2 weeks CGM data with PA vs 2 weeks CGM data with AoT	the difference in the percentage of time spent below 70 mg/dl (TBR \< 70 mg/dl) between the Alarm on Threshold (AoT) and the Predictive Alarm (PA) arms after 2 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Better glycemic metrics using Predictive Alarm vs Alarm on Threshold	2 weeks CGM data with PA vs 2 weeks CGM data with AoT	the difference in the percentage of time spent in 70-180 mg/dl range (TIR) between the Alarm on Threshold (AoT) and Predictive Alarm (PA) arms after 2 weeks of treatment (V2 vs V1 and V4 vs V3); the difference in the percentage of time spent above 250 mg/dl (TAR \> 250 mg/dl) between the Alarm on Threshold and Predictive Alarm arms after 2 weeks of treatment (V2 vs V1 and V4 vs V3).; the difference in main glucose metrics (%TIR, %TBR, %TAR) and glucose variability measures (SD, %CV, MAG, MAGE, HBGI, LBGI, ADRR, CONGA, MODD) between Group A (PA/AoT) and Group B (AoT/PA) at the end of the treatment period (V4) vs baseline (V1)

Trial Locations

Locations (1)

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