Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders

University Hospital Padova

Status: Completed

Conditions: Hypoglycemia; Congenital Hyperinsulinism (CHI); Glycogen Storage Disease

Treatments: Device: Continuous glucose monitor with threshold-only alerts (Dexcom ONE+); Device: Continuous glucose monitor with threshold and predictive alerts (Dexcom G7)

Study type: Interventional

Funder types: Other

Identifiers

NCT07614139

CET 6104/AO/24, URC AOP3544

Details and patient eligibility

About

The goal of this clinical trial is to learn if a continuous glucose monitor (CGM) with predictive alerts works better than a CGM with standard alerts to prevent low blood sugar (hypoglycemia) in adults with inherited metabolic disorders (IMDs), such as glycogen storage disorders (GSDs) and congenital hyperinsulinism (CH).

The main questions it aims to answer are:

Does a CGM with predictive alerts lower the time spent with low blood sugar compared to a CGM with standard alerts? Do participants feel better and behave differently when using a CGM with predictive alerts? How accurate are the two CGM devices in this group of people? Researchers will compare two CGM devices - Dexcom G7 (with predictive and standard alerts) and Dexcom ONE+ (with standard alerts only) - to see if predictive alerts help reduce low blood sugar episodes and improve quality of life.

Participants will:

Wear each CGM device for 30 days Have a 30-day break between the two devices Check blood sugar levels and record food intake Complete questionnaires about their experience with each device

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Genetic or biochemical diagnosis of Glycogen Storage Disease (GSD) or Congenital Hyperinsulinism (CH)
• At least one clinical and biochemical follow-up at the hospital outpatient service within the last one or two years
• Ability to sign informed consent and comply with study procedures

Exclusion criteria

• Inability to sign informed consent or comply with study procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Dexcom G7 (Threshold + Predictive Alerts)

Active Comparator group

Treatment:

Device: Continuous glucose monitor with threshold and predictive alerts (Dexcom G7)

Dexcom ONE+ (Threshold-Only Alerts)

Active Comparator group

Treatment:

Device: Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)