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NCT07097415Befejeződött

CGM-Assisted Community Management for Type 2 Diabetes

Continuous Glucose Monitoring-assisted Management for Type 2 Diabetes in Chinese Community Care: a Non-randomised Pragmatic Type 2 Effectiveness-Implementation Hybrid Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 23.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This non-randomised, parallel-group pragmatic study used a type 2 effectiveness-implementation hybrid design to evaluate a continuous glucose monitoring (CGM)-assisted community management strategy for adults with type 2 diabetes in Yinzhou District, Ningbo, China. The study was conducted at two community health institutions that routinely provided chronic disease management services. Group assignment was not randomised and involved participant self-selection. A total of 599 participants were enrolled, including 292 participants in the CGM-assisted management group and 307 participants in the usual-care group. The intervention was a multicomponent CGM-assisted management strategy rather than the use of a CGM device alone. It included a CGM device with a mobile application and clinician-facing data platform, structured training for community providers, one-to-one patient education, a standardised workflow for interpreting glucose patterns and providing dietary, physical-activity, and medication-management advice, and three scheduled 14-day CGM wear periods at weeks 0, 8, and 16. After each wear period, participants returned for clinician review and management adjustment. Participants in the usual-care group continued routine community diabetes management, including self-monitoring of blood glucose. The primary effectiveness outcome was the between-group difference in HbA1c at 24 weeks. Secondary effectiveness outcomes included clinically meaningful HbA1c reductions and target attainment, fasting plasma glucose, body-mass index, lipid measures, behavioural changes, and changes in glucose-lowering medication management. CGM-derived glycaemic metrics were assessed descriptively within the intervention group across the three wear periods. Implementation outcomes were evaluated using the RE-AIM framework and included study-period reach, institutional and provider adoption, intervention delivery fidelity, participant completion, provider-perspective delivery cost, willingness to continue CGM use, participant satisfaction, and continuation of CGM-related services at the participating sites. The study aimed to assess both the effectiveness of CGM-assisted management and its implementation within routine Chinese community diabetes care.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
599 (tényleges)
Első benyújtás
2025. júl. 4.
Kezdés
2024. nov. 15.
Elsődleges befejezés
2025. nov. 30.
Fő szponzor
Peking University
NCT-szám
NCT07097415

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 599
  • 2024. nov. 15. és az elsődleges befejezés (2025. nov. 30.) között
  • 2 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Laborértékek

  • Pregnancy.
    • Type 1 diabetes, latent autoimmune diabetes in adults, or secondary diabetes.
    • Current or previous use of glucose-affecting agents other than prescribed glucose-lowering medication, including systemic glucocorticoids.
    • Estimated glomerular filtration rate below 60 mL/min/1·73 m². ⑤Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal.
    • Active malignancy. ⑦Inability to provide informed consent.

Kiket keres a vizsgálat

  • Age 18 years or older. ②A diagnosis of type 2 diabetes recorded in the electronic medical record for at least 1 year before screening.
    • A stable glucose-lowering treatment regimen, defined as no change in medication class during the 3 months before screening.
    • Residence in Yinzhou District and enrolment in the district resident health-record system.
    • Ability to provide written informed consent. ⑥For enrolment into the CGM-assisted management group, ability to operate the CGM mobile application independently or with assistance from a caregiver.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (2)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Fuming Street Community Health Service CenterNingboKínaIsmeretlen állapot
Qianhu HospitalNingboKínaIsmeretlen állapot

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