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

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia; Device: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia

Study type: Interventional

Funder types: Other

Identifiers

NCT05574023

3142CESC

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Predictive Alarm (PA)

Experimental group

Description:

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.

Treatment:

Device: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia

Alarm on Threshold (AoT)

Active Comparator group

Description:

Patients use the CGM sensor with alarms on a threshold of 70 mg/dl for hypoglycemia and 250 mg/dl for hyperglycemia.

Treatment:

Device: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia