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Trial of CGM Technology in Persons Living With Prediabetes (CGM)

26. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Stelo CGM Device
50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study.
Gerät: Stelo CGM
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.
Andere Namen:
  • Simple Sugar Tracking
Kein Eingriff: Control Group - no Device
50 subjects will be treated as standard of care with no CGM interventions.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
A1c value
Zeitfenster: Baseline
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
Baseline
A1c value
Zeitfenster: Month 3
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
Month 3
CGM value
Zeitfenster: Baseline
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.
Baseline
CGM value
Zeitfenster: 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.
Month 1
CGM value
Zeitfenster: Month 2
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.
Month 2
CGM value
Zeitfenster: 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.
Month 3
Weight monitoring
Zeitfenster: Baseline
Weight measurement will be collected
Baseline
Weight monitoring
Zeitfenster: Month 1
Weight measurement will be collected
Month 1
Weight monitoring
Zeitfenster: Month 2
Weight measurement will be collected
Month 2
Weight monitoring
Zeitfenster: Month 3
Weight measurement will be collected
Month 3
Blood Pressure Monitoring
Zeitfenster: Baseline

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
Blood Pressure Monitoring
Zeitfenster: Month 1

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
Blood Pressure Monitoring
Zeitfenster: Month 2

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
Blood Pressure Monitoring
Zeitfenster: Month 3

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Continuous Glucose Monitoring As a Behavior Modification Tool Survey
Zeitfenster: Month 3
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
Month 3

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Ermittler

  • Hauptermittler: Catherine Price, MD, Wake Forest University Health Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Mai 2027

Studienabschluss (Geschätzt)

1. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. August 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00143795

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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