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

NCT07614139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-05-29

No results posted yet for this study

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

Conditions

  • Glycogen Storage Disease
  • Congenital Hyperinsulinism (CHI)
  • Hypoglycemia

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • University Hospital Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614139 on ClinicalTrials.gov