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Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study (GUIDE)

1. juli 2026 opdateret af: Yale University
The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Participants will complete a total of three study visits: a baseline visit (which includes consent, screening, and enrollment procedures), a 16-week follow-up visit, and a 32-week follow-up visit. Each study visit is expected to last approximately 30 minutes. In addition, participants will complete study surveys throughout the study period, which are expected to require approximately 30-40 minutes per survey. Depending on study group assignment, participants may also use study devices and mobile applications to track health behaviors and/or participate in telehealth visits with a healthcare provider. The frequency and duration of these activities will vary by study group.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06477
        • Yale School of Nursing

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • diagnosis of T2D for at least one year
  • recent 3 month-HbA1c, 8-11%
  • ownership of a smartphone
  • English or Spanish speaking.

Exclusion Criteria:

  • pregnant
  • not available or willing to use CGM or study device/platform
  • serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)

In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Group A: Continuous Glucose Monitoring (CGM)-only
Continuous Glucose Monitoring (CGM)-only
Eksperimentel: Group B: Integrated Digital Health (IDH) platform without provider engagement
IDH without provider engagement
Adfærdsmæssigt: Integrated Digital Health (IDH) platform
CGM, wearable for physical activity and sleep, food scan/log
Eksperimentel: Group C: Integrated Digital Health (IDH) platform with provider engagement
IDH with provider engagement
Adfærdsmæssigt: Integrated Digital Health (IDH) platform
CGM, wearable for physical activity and sleep, food scan/log
Adfærdsmæssigt: Provider engagement
Weekly feedback through the IDH platform plus monthly video calls

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Hemoglobin A1c (HbA1c)
Tidsramme: Baseline, 16 weeks and 32 weeks
HbA1c in milligrams per deciliter (mg/dL) will be measured using blood testing conducted according to the standardized procedures of the National Glycohemoglobin Standardization Program (NGSP).
Baseline, 16 weeks and 32 weeks
Mean Glucose Variability (Coefficient of Variation [%CV])
Tidsramme: Baseline, 16 weeks and 32 weeks
Glucose variability will be derived from continuous glucose monitoring (CGM) data and calculated as the coefficient of variation (CV = standard deviation/mean glucose × 100). This measure reflects intra- and inter-day fluctuations in glucose levels. Consistent with consensus recommendations, a CV ≤36% is considered stable glucose variability.
Baseline, 16 weeks and 32 weeks
Percentage of glucose readings with Time in Range (TIR)
Tidsramme: Baseline, 16 weeks and 32 weeks
TIR will be derived from CGM data and calculated as the percentage of glucose readings and time per day within the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Consistent with consensus recommendations, a TIR ≥70% is considered an indicator of optimal glycemic management.
Baseline, 16 weeks and 32 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)
Tidsramme: Baseline, 16 weeks and 32 weeks
12-item validated measure evaluating adherence to diabetes self-care behaviors, including diet, physical activity, blood glucose monitoring, and medication adherence. Total score range 0-7 with higher scores indicating more adherence.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Management Self-Efficacy Scale
Tidsramme: Baseline, 16 weeks and 32 weeks
20-item validated instrument measuring participants' confidence in their ability to manage diabetes-related tasks and challenges. Total score range 1-5 with higher scores indicating a greater level of self-efficacy.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Distress Scale
Tidsramme: Baseline, 16 weeks and 32 weeks
17-item scale which assesses distress associated with diabetes management, healthcare providers, emotional burden, and interpersonal concerns. Total score range 1-6 with higher scores indicating more distress.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Quality of Life Brief Clinical Inventory
Tidsramme: Baseline, 16 weeks and 32 weeks
15-item validated instrument evaluating the impact of diabetes on physical, emotional, and social well-being. Total score range 1-5 with higher scores indicating a more negative perspective of the condition.
Baseline, 16 weeks and 32 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yale University

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Yale University School of Nursing

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. marts 2031

Studieafslutning (Anslået)

1. marts 2031

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2000043169
  • 1R01DK149276-01 (Andet bevillings-/finansieringsnummer: NIH)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified study data will be shared per NIH data sharing policy.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Integrated Digital Health (IDH) platform

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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