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Pilotstudie som forbedrer telemedisin for T2D

3. november 2026 oppdatert av: Margaret Zupa, University of Pittsburgh

Pilotstudie som forbedrer telemedisinsk omsorg for voksne med kompleks type 2-diabetes

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:

Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?

Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.

Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

Studieoversikt

Detaljert beskrivelse

This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.

Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.

The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.

Studietype

Intervensjonell

Registrering (Faktiske)

43

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • adults 18 years or older
  • Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
  • HbA1c greater than or equal to 8% based on most recent value at time of recruitment
  • Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
  • Patient must use insulin
  • Patients must have >2 comorbid chronic health conditions
  • Be able to provide informed consent
  • Reside in Pennsylvania

Exclusion criteria:

  • Age over 80 based on date of birth in electronic medical record

  • Visit with an endocrinologist in the prior 1 years

  • Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition

    • Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
    • Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
    • ESRD N18.6
  • Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition

    • Type 1 diabetes: E10.X
    • Gestational diabetes: O24.X, E08.X
    • Other diabetes: E09.X, E13.2
  • Pregnant or planning to become pregnant in next 6 months

  • Currently enrolled in another diabetes management intervention study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Enhanced Telemedicine Care

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team.

Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up.

Aktiv komparator: Usual Care

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.

Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment percentage
Tidsramme: 12 months

Percent of eligible patients approached who are enrolled

12 months
Loss to follow up
Tidsramme: 6 months

Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys

6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 12 months

Number of patients recruited per month

12 months
Eligibility percentage
Tidsramme: 12 months

Percent of patients approached who are eligible

12 months
Visit attendance
Tidsramme: 6 months

Percent of scheduled visits completed per patient

6 months
Number of between-visit contacts
Tidsramme: 6 months

Number of successful and attempted patient contacts by clinicians between visits per patient

6 months
Blood glucose data availability
Tidsramme: 6 months

Number of telemedicine visits with blood glucose data available at visit per patient

6 months
Patient satisfaction with telemedicine diabetes care
Tidsramme: 6 months

Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction

6 months
Diabetes Treatment Satisfaction Questionnaire-static version
Tidsramme: Baseline

Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems.

Baseline
Diabetes Treatment Satisfaction Questionnaire-change version
Tidsramme: 6 months

Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now').

Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before.

6 months
T2D Diabetes Distress Core Scale
Tidsramme: Baseline and 6 months

Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress.

Baseline and 6 months
HbA1c change
Tidsramme: Baseline and 6 months

Change in glycemic control from baseline to 6 months

Baseline and 6 months
Prescription of guideline-based GLP-1 receptor agonist
Tidsramme: Baseline and 6 months

Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication

Baseline and 6 months
Prescription of guideline-based SGLT2 inhibitor
Tidsramme: Baseline and 6 months

Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication

Baseline and 6 months
Retinal examination
Tidsramme: 6 months

Number of patients with documentation of retinal examination performed in last year in medical record

6 months
Urine protein testing
Tidsramme: 6 months

Number of patients with documentation of urine protein testing performed in last year in medical record

6 months
Immunization-pneumococcal
Tidsramme: 6 months

Number of patients with documentation of pneumococcal vaccination in medical record

6 months
Immunization-influenza
Tidsramme: 6 months

Number of patients with documentation of influenza vaccination in medical record

6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Margaret Zupa, MDMS, University of Pittsburgh

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. februar 2025

Primær fullføring (Antatt)

30. januar 2027

Studiet fullført (Antatt)

30. januar 2027

Datoer for studieregistrering

Først innsendt

13. desember 2024

Først innsendt som oppfylte QC-kriteriene

13. desember 2024

Først lagt ut (Faktiske)

18. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • STUDY24060062
  • K23DK135794 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.

IPD-delingstidsramme

The data will become available no later than 12 months and ending 36 months after the primary trial results are published.

Tilgangskriterier for IPD-deling

No access will be granted until the requesting investigator vetting process is completed including an IRB-approved protocol and data use agreement with the University of Pittsburgh.The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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