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Studio pilota sul miglioramento della telemedicina per il T2D

3 novembre 2026 aggiornato da: Margaret Zupa, University of Pittsburgh

Studio pilota sul miglioramento dell’erogazione delle cure di telemedicina per gli adulti affetti da diabete di tipo 2 complesso

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

43

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.

Luoghi di studio

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • University of Pittsburgh

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

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment percentage
Lasso di tempo: 12 months

Percent of eligible patients approached who are enrolled

12 months
Loss to follow up
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rate
Lasso di tempo: 12 months

Number of patients recruited per month

12 months
Eligibility percentage
Lasso di tempo: 12 months

Percent of patients approached who are eligible

12 months
Visit attendance
Lasso di tempo: 6 months

Percent of scheduled visits completed per patient

6 months
Number of between-visit contacts
Lasso di tempo: 6 months

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

6 months
Blood glucose data availability
Lasso di tempo: 6 months

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

6 months
Patient satisfaction with telemedicine diabetes care
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 months

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

6 months
Urine protein testing
Lasso di tempo: 6 months

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

6 months
Immunization-pneumococcal
Lasso di tempo: 6 months

Number of patients with documentation of pneumococcal vaccination in medical record

6 months
Immunization-influenza
Lasso di tempo: 6 months

Number of patients with documentation of influenza vaccination in medical record

6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Margaret Zupa, MDMS, University of Pittsburgh

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 (Effettivo)

3 febbraio 2025

Completamento primario (Stimato)

30 gennaio 2027

Completamento dello studio (Stimato)

30 gennaio 2027

Date di iscrizione allo studio

Primo inviato

13 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

13 dicembre 2024

Primo Inserito (Effettivo)

18 dicembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • STUDY24060062
  • K23DK135794 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

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

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 .