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Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
Sponsor: University Hospital Padova
Summary
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
Official title: Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders Prone to Hypoglycemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2025-01-08
Completion Date
2025-09-30
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
Continuous glucose monitor with threshold and predictive alerts (Dexcom G7)
The Dexcom G7 is a CE-marked continuous glucose monitoring (CGM) device worn for 30 days. It provides real-time interstitial glucose readings every 5 minutes. The device offers both threshold-based alerts, activated when glucose levels fall below or rise above pre-set values, and predictive alerts, activated when glucose levels are predicted to reach a threshold within 20 minutes. The low glucose alert threshold was set at 70 mg/dL for all participants.
Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
The Dexcom ONE+ is a CE-marked continuous glucose monitoring (CGM) device worn for 30 days. It provides real-time interstitial glucose readings every 5 minutes. The device offers threshold-based alerts only, activated when glucose levels fall below or rise above pre-set values, without predictive alert functionality. The low glucose alert threshold was set at 70 mg/dL for all participants.
Locations (1)
University Hospital of Padova
Padova, Padova, Italy