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| Name | Class |
|---|---|
| University of Padova | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G7 (Threshold + Predictive Alerts) | Active Comparator |
| |
| Dexcom ONE+ (Threshold-Only Alerts) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Time Frame: 30 days per device |
| Time Above Range (TAR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Padova | Padova | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39352577 | Background | 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. | |
| 35786777 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2024 |
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|
| 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. |
|
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 |
| 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 | 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: % | 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. | 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) | 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) | 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) | 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 | 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 | Baseline and after 30 days per device |
| 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. |
| 39243574 | 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. |
| 33834518 | 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. |
| 33340416 | 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. |
| May 21, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006008 | Glycogen Storage Disease |
| D044903 | Congenital Hyperinsulinism |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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