Glycogen Storage DiseaseNCT07614139
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
A study testing Continuous glucose monitor with threshold and predictive alerts (Dexcom G7) and Continuous glucose monitor with threshold-only alerts (Dexcom ONE+) in people with Glycogen Storage Disease and Congenital Hyperinsulinism (CHI), run by University Hospital Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycogen Storage Disease, Congenital Hyperinsulinism (CHI), Hypoglycemia
- What is being tested?
- Continuous glucose monitor with threshold and predictive alerts (Dexcom G7) and Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to sign informed consent or comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders Prone to Hypoglycemia
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:
Read more
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
- Being tested
- Continuous glucose monitor with threshold and predictive alerts (Dexcom G7), Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
- Medical subject headings
- Glycogen Storage Disease, Congenital Hyperinsulinism, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G7 (Threshold + Predictive Alerts) | Active comparator | Not described Receives: Device: Continuous glucose monitor with threshold and predictive alerts (Dexcom G7) |
| Dexcom ONE+ (Threshold-Only Alerts) | Active comparator | Not described Receives: Device: Continuous glucose monitor with threshold-only alerts (Dexcom ONE+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days per device (total study duration: approximately 90 days including washout period)
Secondary outcomes (10)
Time in Range (TIR)
Percentage of time spent with interstitial glucose levels within the target range of 70-140 mg/dL, as measured by CGM over 30 days for each device. Expressed as percentage of monitoring time (%).
Unit of Measure: % of monitoring time
Measured: Time Frame: 30 days per device
Time Above Range (TAR)
Percentage of time spent with interstitial glucose levels above 140 mg/dL, as measured by CGM over 30 days for each device. Expressed as percentage of monitoring time (%).
Unit of Measure: % of monitoring time
Measured: Time Frame: 30 days per device
Mean Glucose Level
Mean interstitial glucose levels calculated over 24 hours and during nighttime (00:00-07:00), as measured by CGM over 30 days for each device.
Unit of Measure: mg/dL
Measured: Time Frame: 30 days per device
Sensor Accuracy - median absolute relative difference (MARD)
Accuracy of CGM readings compared to capillary blood glucose reference values (Accu-Check Instant, Roche), expressed as Median Absolute Relative Difference (MARD). Capillary and CGM values matched within a ±5-minute time window.
Unit of Measure: %
Measured: 30 days per device
Dietary Intake Assessment
Total daily energy intake measured during each device wear period Unit of Measure: kcal/day Total daily macronutrient intake measured during each device wear period Unit of Measure: grams/day Daily uncooked cornstarch intake measured during each device wear period Unit of Measure: grams/day All dietary intakes were assessed by 7-day food diary analyzed with Metadieta® software (Meteda Srl, Italy), completed during CGM monitoring and reviewed by an experienced metabolic dietitian.
Measured: 7 days per device
Hypoglycemia Fear and Protective Behaviors Assessment
Assessed using the Hypoglycemia Fear Survey (HFS), comprising two subscales: Worry (HFS-W) and Behavior (HFS-B). Each item scored 0-4; total range 0-132; higher scores indicate greater fear of hypoglycemia and more behaviors engaged to avoid hypoglycemic episodes.
Unit of Measure: Score (0-132)
Measured: baseline and after 30 days per device
Hypoglycemia Awareness Assessment
Assessed using the Clarke Hypoglycemia Awareness Questionnaire (CHAQ), comprising 8 items on hypoglycemia awareness and recognition. Range 0-7; scores ≥4 indicate impaired awareness of hypoglycemia; higher scores indicate worse hypoglycemia awareness.
Unit of Measure: Score (0-7)
Measured: baseline and after 30 days per device
Sleep Quality Assessment
assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire assessing sleep quality and disturbances over the previous month. Global score ranges from 0 to 21; scores >5 indicate poor sleep quality; higher scores indicate worse sleep quality.
Unit of Measure: Score (0-21)
Measured: Baseline and after 30 days per device
Health-Related Quality of Life Assessment
Assessed using the 12-Item Short Form Health Survey (SF-12), yielding Physical Component Summary (PCS) and Mental Component Summary (MCS) standardized scores. Higher scores indicate better quality of life.
Unit of Measure: Standardized score for Italian population
Measured: Baseline and after 30 days per device
Body Mass Index (BMI)
Height measured at baseline; weight measured at the start and end of each CGM period using a calibrated mechanical scale (Seca 700). BMI calculated as weight (kg)/height² (m²), interpreted according to WHO classification: <18.5 underweight; 18.5-25 healthy weight; 25-30 overweight; >30 obesity.
Unit of Measure: kg/m²
Measured: Baseline and after 30 days per device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start8 Jan 2025
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Glycogen Storage DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Nicola Vitturi, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614139
- Sponsor's protocol ID
- CET 6104/AO/24, URC AOP3544
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39352577Rossi 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.
PubMed 35786777Overduin 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.
PubMed 39243574Peeks 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.
PubMed 33834518Ferreira 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.
PubMed 33340416
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders Prone to Hypoglycemia
- ClinicalTrials.gov ID
- NCT07614139
- Acronym / sponsor ID
- CET 6104/AO/24, URC AOP3544
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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+) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to sign informed consent or comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dexcom G7 (Threshold + Predictive Alerts) |
| 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. | Device | Dexcom ONE+ (Threshold-Only Alerts) |
Primary outcome
Time Below Range (TBR)
Time frame: 30 days per device (total study duration: approximately 90 days including washout period)
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
10 secondary outcomes
Time in Range (TIR)
Time frame: Time Frame: 30 days per device
Time Above Range (TAR)
Time frame: Time Frame: 30 days per device
Mean Glucose Level
Time frame: Time Frame: 30 days per device
Sensor Accuracy - median absolute relative difference (MARD)
Time frame: 30 days per device
Dietary Intake Assessment
Time frame: 7 days per device
Hypoglycemia Fear and Protective Behaviors Assessment
Time frame: baseline and after 30 days per device
Hypoglycemia Awareness Assessment
Time frame: baseline and after 30 days per device
Sleep Quality Assessment
Time frame: Baseline and after 30 days per device
Health-Related Quality of Life Assessment
Time frame: Baseline and after 30 days per device
Body Mass Index (BMI)
Time frame: Baseline and after 30 days per device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 39352577Gugelmo 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.
- Background: PubMed 35786777Rossi 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.
- Background: PubMed 39243574Overduin 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.
- Background: PubMed 33834518Peeks 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.
- Background: PubMed 33340416Ferreira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor with threshold and predictive alerts (Dexcom G7) and Continuous glucose monitor with threshold-only alerts (Dexcom ONE+) in people with Glycogen Storage Disease and Congenital Hyperinsulinism (CHI), run by University Hospital Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Below Range (TBR) (time frame: 30 days per device (total study duration: approximately 90 days including washout period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614139, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.