Trial of CGM Technology in Persons Living With Prediabetes (CGM)
26 agosto 2026 aggiornato da: Wake Forest University Health Sciences
Trial of Continuous Glucose Monitoring (CGM) Technology in Persons Living With Prediabetes
Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes.
While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.
Panoramica dello studio
Descrizione dettagliata
Additional investigation is strongly needed to further evaluate the health impacts of CGM technology in persons living with prediabetes.
This study is looking to study the impact that CGM technology could have on glycemic control in patients with prediabetes, as well as secondary outcomes, such as blood pressure, weight, and patient insight into their condition and the effect on lifestyle interventions on glycemic control.
The primary objective of this study is to determine the effect of CGM technology on glycemic control in patients with prediabetes, measured by the endpoints of A1c and CGM data.
Specifically, CGM data will include Time-In-Range (TIR), Time-AboveRange (TAR), Time-Below-Range (TBR), Glycemic management indicator (GMI), and variability measures.
Secondary endpoints include blood pressure, weight, and standardized survey data assessing behavioral modifications as a result of CGM technology.
Tipo di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Meghan Willoughby, MD
- Numero di telefono: 317-938-5421
- Email: meghan.willoughby@advocatehealth.org
Backup dei contatti dello studio
- Nome: Catherine Price, MD
- Numero di telefono: 912-682-0558
- Email: Catherine.Price@wfusm.edu
Luoghi di studio
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Health Sciences
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Contatto:
- Meghan Willoughby, MD
- Numero di telefono: 317-938-5421
- Email: meghan.willoughby@advocatehealth.org
-
Contatto:
- Catherine Price, MD
- Numero di telefono: 912-682-0558
- Email: Catherine.Price@wfusm.edu
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or > than 5.7% and < or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application
- Greater than or equal to 18 years old
Exclusion Criteria:
- Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c > or = 6.5%
- Subjects who do not have reliable access to a smartphone device compatible with the CGM application
- Pregnant patients
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Stelo CGM Device
50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study.
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The Stelo Glucose Biosensor is built on the most accurate continuous glucose monitoring technology from Dexcom and is simple and painless to apply.
By sending glucose levels directly to your smartphone,* it gives you just the right amount of information to work with.
Altri nomi:
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Nessun intervento: Control Group - no Device
50 subjects will be treated as standard of care with no CGM interventions.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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A1c value
Lasso di tempo: Baseline
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An A1C test measures your average blood sugar levels over the past 2 to 3 months.
It is reported as a percentage.
A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal
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Baseline
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A1c value
Lasso di tempo: Month 3
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An A1C test measures your average blood sugar levels over the past 2 to 3 months.
It is reported as a percentage.
A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal
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Month 3
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CGM value
Lasso di tempo: Baseline
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Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7.
It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL).
Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2).
Goal: Keep as low as possible.
Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia).
Goal: Less than 4% of the time, to eliminate dangerous lows.
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Baseline
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CGM value
Lasso di tempo: Month 1
|
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7.
It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL).
Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2).
Goal: Keep as low as possible.
Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia).
Goal: Less than 4% of the time, to eliminate dangerous lows.
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Month 1
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CGM value
Lasso di tempo: Month 2
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Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7.
It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL).
Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2).
Goal: Keep as low as possible.
Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia).
Goal: Less than 4% of the time, to eliminate dangerous lows.
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Month 2
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CGM value
Lasso di tempo: Month 3
|
Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7.
It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL).
Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2).
Goal: Keep as low as possible.
Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia).
Goal: Less than 4% of the time, to eliminate dangerous lows.
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Month 3
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Weight monitoring
Lasso di tempo: Baseline
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Weight measurement will be collected
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Baseline
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Weight monitoring
Lasso di tempo: Month 1
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Weight measurement will be collected
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Month 1
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Weight monitoring
Lasso di tempo: Month 2
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Weight measurement will be collected
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Month 2
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Weight monitoring
Lasso di tempo: Month 3
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Weight measurement will be collected
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Month 3
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Blood Pressure Monitoring
Lasso di tempo: Baseline
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Systolic (Top Number)Diastolic (Bottom Number) Normal - Less than 120and Less than 80 Elevated - 120 - 129 and Less than 80 Hypertension Stage 1 - 130 - 139 or 80 - 89 Hypertension Stage 2 -140 or higher or 90 or higher Hypertensive Crisis - Higher than 180 and/or Higher than 120 |
Baseline
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Blood Pressure Monitoring
Lasso di tempo: Month 1
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Systolic (Top Number)Diastolic (Bottom Number) Normal - Less than 120and Less than 80 Elevated - 120 - 129 and Less than 80 Hypertension Stage 1 - 130 - 139 or 80 - 89 Hypertension Stage 2 -140 or higher or 90 or higher Hypertensive Crisis - Higher than 180 and/or Higher than 120 |
Month 1
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Blood Pressure Monitoring
Lasso di tempo: Month 2
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Systolic (Top Number)Diastolic (Bottom Number) Normal - Less than 120and Less than 80 Elevated - 120 - 129 and Less than 80 Hypertension Stage 1 - 130 - 139 or 80 - 89 Hypertension Stage 2 -140 or higher or 90 or higher Hypertensive Crisis - Higher than 180 and/or Higher than 120 |
Month 2
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Blood Pressure Monitoring
Lasso di tempo: Month 3
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Systolic (Top Number)Diastolic (Bottom Number) Normal - Less than 120and Less than 80 Elevated - 120 - 129 and Less than 80 Hypertension Stage 1 - 130 - 139 or 80 - 89 Hypertension Stage 2 -140 or higher or 90 or higher Hypertensive Crisis - Higher than 180 and/or Higher than 120 |
Month 3
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Continuous Glucose Monitoring As a Behavior Modification Tool Survey
Lasso di tempo: Month 3
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The results will be discussed by describing the percent of patients that said "Yes," "No," or "I don't know" to the questions - percentage data
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Month 3
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Catherine Price, MD, Wake Forest University Health Sciences
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 maggio 2027
Completamento dello studio (Stimato)
1 maggio 2027
Date di iscrizione allo studio
Primo inviato
5 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 giugno 2026
Primo Inserito (Effettivo)
10 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 agosto 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00143795
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .