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

NCT07614139 | Completed

• 1 other identifier: CET 6104/AO/24, URC AOP3544
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time Below Range (TBR)

  Percentage of time spent with interstitial glucose levels below 70 mg/dL, as measured by continuous glucose monitoring (CGM). TBR is reported at two thresholds: TBR1 (54-69 mg/dL) and TBR2 (\<54 mg/dL), both expressed as percentage of monitoring time (%), over 30 days for each device. Unit of Measure: % of monitoring time

  30 days per device (total study duration: approximately 90 days including washout period)

Secondary Outcomes (10)

• Time in Range (TIR)

  Time Frame: 30 days per device

• Time Above Range (TAR)

  Time Frame: 30 days per device

• Mean Glucose Level

  Time Frame: 30 days per device

• Sensor Accuracy - median absolute relative difference (MARD)

  30 days per device

• Dietary Intake Assessment

  7 days per device

Study Arms (2)

Dexcom G7 (Threshold + Predictive Alerts)

ACTIVE COMPARATOR

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

Dexcom ONE+ (Threshold-Only Alerts)

ACTIVE COMPARATOR

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

Interventions

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

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.

Dexcom G7 (Threshold + Predictive Alerts)

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

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.

Dexcom ONE+ (Threshold-Only Alerts)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to sign informed consent or comply with study procedures

Sponsors & Collaborators

• University of Padova: collaborator
• University Hospital Padova: lead

Study Sites (1)

University Hospital of Padova

Padova, Padova, 35128, Italy

Location

Related Publications (5)

• Gugelmo G, Maines E, Boscari F, Lenzini L, Fadini GP, Burlina A, Avogaro A, Vitturi N. Continuous glucose monitoring in patients with inherited metabolic disorders at risk for Hypoglycemia and Nutritional implications. Rev Endocr Metab Disord. 2024 Oct;25(5):897-910. doi: 10.1007/s11154-024-09903-y. Epub 2024 Oct 1.

  PMID: 39352577 BACKGROUND

• Rossi A, Venema A, Haarsma P, Feldbrugge L, Burghard R, Rodriguez-Buritica D, Parenti G, Oosterveer MH, Derks TGJ. A Prospective Study on Continuous Glucose Monitoring in Glycogen Storage Disease Type Ia: Toward Glycemic Targets. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3612-e3623. doi: 10.1210/clinem/dgac411.

  PMID: 35786777 BACKGROUND

• Overduin RJ, Venema A, Lubout CMA, Fokkert-Wilts MJ, De Boer F, Schreuder AB, Rossi A, Derks TGJ. Continuous glucose monitoring metrics in people with liver glycogen storage disease and idiopathic ketotic hypoglycemia: A single-center, retrospective, observational study. Mol Genet Metab. 2024 Sep-Oct;143(1-2):108573. doi: 10.1016/j.ymgme.2024.108573. Epub 2024 Aug 30.

  PMID: 39243574 BACKGROUND

• Peeks F, Hoogeveen IJ, Feldbrugge RL, Burghard R, de Boer F, Fokkert-Wilts MJ, van der Klauw MM, Oosterveer MH, Derks TGJ. A retrospective in-depth analysis of continuous glucose monitoring datasets for patients with hepatic glycogen storage disease: Recommended outcome parameters for glucose management. J Inherit Metab Dis. 2021 Sep;44(5):1136-1150. doi: 10.1002/jimd.12383. Epub 2021 May 5.

  PMID: 33834518 BACKGROUND

• Ferreira CR, Rahman S, Keller M, Zschocke J; ICIMD Advisory Group. An international classification of inherited metabolic disorders (ICIMD). J Inherit Metab Dis. 2021 Jan;44(1):164-177. doi: 10.1002/jimd.12348.

  PMID: 33340416 BACKGROUND

MeSH Terms

Conditions

Glycogen Storage Disease; Congenital Hyperinsulinism; Hypoglycemia

Condition Hierarchy (Ancestors)

Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Specialist in Rare Adult Metabolic Diseases at the Division of Metabolic Diseases

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: January 8, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)