- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05580978
CGM Plus GEM i prædiabetes (IMPEDE)
Libre 2 CGM Plus Glykæmisk udflugtsminimering (GEM) i behandling af prædiabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado- Anschutz Medical Campus
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder 25-70 år
- A1C 6,0-6,4
- Dokumenteret diagnose af prædiabetes
- Hav en smartphone
- Kan læse engelsk, da GEM-guiden i øjeblikket kun er tilgængelig på engelsk
- Villig og i stand til at følge studieprocedurerne som anvist
Ekskluderingskriterier:
- Diagnose af diabetes mellitus
- Tager i øjeblikket enhver diabetesmedicin
- Tager i øjeblikket medicin, der fremmer insulinresistens eller på anden måde forstyrrer metabolisk kontrol (f.eks. prednison)
- Har en tilstand, der udelukker en diæt med lavt kulhydratindhold, såsom gastroparese
- Har en fysisk eller medicinsk tilstand, der udelukker at gå 120 skridt i minuttet i 10 minutter eller længere
- Har dokumenteret nyresygdom, der ville udelukke deltagelse i undersøgelse efter PI skøn
- Aktiv eller planlagt kræftbehandling
- Ekstrem syns- eller hørenedsættelse, der ville svække evnen til at bruge real-time CGM
- Gravid eller forventer at blive gravid inden for de næste 4 måneder
- Forventer flytning inden for de næste 4 måneder
- Behandler læge, uanset årsag, anser deres patient for upassende til undersøgelsen (f.eks. ukontrolleret bipolar sygdom)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: GEM + CGM + Aktivitetsmonitor
GEM plus CGM og Activity Monitor (FitBit)
|
Interventionsgruppen får Libre 2-forsyninger i 4 måneder, en aktivitetsmonitor og GEM-papirguiden med 4 kapitler.
Interventionsgruppen vil gennemføre et virtuelt eller personligt studiebesøg, hvor de vil modtage instruktioner om, hvordan de anvender deres ublindede Freestyle Libre og forbinder den med undersøgelseskontoen, samt hvordan de registrerer deres Fitbit til undersøgelseskontoen.
Deltagerne vil modtage et telefonopkald for at gennemgå brugen af GEM-guiden og ringe til to uger og seks uger senere, når sandsynligheden for frafald fra livsstilsintervention topper.
Deltagerne vil følge den selvstyrende GEM-guide i 4 måneder (en 1-måneders behandlingsperiode efterfulgt af en 3-måneders vedligeholdelsesperiode), mens de bærer en FitBit-aktivitetsmonitor og en Freestyle Libre 2 CGM.
|
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Aktiv komparator: Rutinemæssig pleje
Sædvanlig pleje modtages allerede for prædiabetes som behandlet af deres plejeteam.
|
Deltagerens nuværende prædiabetesbehandling.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Percentage of CGM Glucose Readings > 120 mg/dL
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in percentage of CGM glucose readings > 120 mg/dL from pre-intervention (baseline) blinded CGM to post-intervention (4.5 months) blinded CGM.
|
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in HbA1c
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in HbA1c from pre-intervention (baseline) to post-intervention (4.5 months).
|
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Change in Glucose Variability
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in glucose variability (GV%) as measured by CGM, from pre-intervention (baseline) to post-intervention (4.5 months). Glucose variability was measured by CGM metrics coefficient of variation (%CV) and Standard Deviation (SD). |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Change in Body Mass Index
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in Body Mass Index (BMI) from pre-intervention (baseline) to post-intervention (4.5 months).
|
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Change in Cardiovascular Risk
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in cardiovascular risk as calculated by a validated risk calculator from pre-intervention (baseline) to post-intervention (4.5 months). The ASCVD Risk Estimator Plus was used to calculate cardiovascular risk. It provides a percentage score that estimates 10-year risk of having a heart attack or stroke. Low risk <5%, Borderline (5%-7.4%) Intermediate (7.5%-19.9%) High (> 20%). |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Change in Empowerment
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in empowerment as measured by modified Diabetes Empowerment Scale-Short Form, from pre-intervention (baseline) to post-intervention (4.5 months). The Diabetes Empowerment Scale-Short Form measures the psychosocial self-efficacy of people with diabetes. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. All items are summed, "Low" = 8-20, "Moderate" = 21-30, "High" = 31-40. Possible scores on the scale ranges from 8-40. |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
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|
Change in Depressive Symptoms
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in depression score as measured by PHQ-8 at pre-intervention (baseline) and post-intervention (4.5 months). The Patient Health Questionnaire-8 is a self-report screening tool for depression. Each item scores 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 24, with higher scores indicating greater depression severity. |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Change in Diabetes Knowledge
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in diabetes knowledge as measured by a modified Diabetes Knowledge Scale from pre-intervention (baseline) to post-intervention (4.5 months). The Diabetes Knowledge Scale is a valid measure containing 30 questions for assessing diabetes knowledge. The items are scored as correct or incorrect, and the correct items were summed to obtain a total score. Scores range from 0 to 30, with higher scores indicating greater knowledge. |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
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Dietary Habits
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in dietary habits as measured by Carbohydrate Routine Consumption Scale (CRC) from pre-intervention (baseline) to post-intervention (4.5 months). The CRC measures carb intake, focusing on how much and what kind (high vs. low glycemic impact), rather than daily total grams. Scoring involves evaluating foods on a 4 or 5-point scale based on nutrients like fiber, free sugars, sodium, and potassium, guiding better choices by highlighting healthier options within carb categories, with higher scores indicating better quality. The CRC score is the sum of the number of servings of 16 different high-carb food classes eaten (e.g., dried fruits) in an average week. There are no subscales. Scale minimum is 0 (zero consumption of high-carb food foods). There is no scale maximum (people may eat as many servings of high glycemic load foods as they like). The CRC is not a comprehensive nutritional analysis. https://diabetesjournals.org/diabetes/article/68/Supplement_1/806-P/58163 |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
|
Motivation and Attitudes Toward Changing Health
Tidsramme: Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Change in Motivation and Attitudes Toward Changing Health (MATCH) score from pre-intervention (baseline) to post-intervention (4.5 months). The Motivation and Attitudes Toward Changing Health (MATCH) is a 9-item scale that provides a profile of factors influencing motivation. Patients rate their agreement on a 5-point scale (1=Strongly Disagree, 5=Strongly Agree). An average of all items or subscales provides an overall score/motivational profile. Higher Scores (closer to 5) indicate stronger motivation, ability, and belief in the value of change, while lower Scores (closer to 1) suggest potential barriers, such as ambivalence, perceived lack of control, or feeling changes aren't impactful. |
Pre-Intervention (Baseline) to post Intervention (4.5 Months)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tamara Oser, MD, Associate Professor, Dept. Family Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 21-4931
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