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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes (T2DM)
• Intervention / Treatment: Device: Yuwell Anytime CT3A Continuous Glucose Monitoring System; Other: CGM-Assisted Community Management Strategy

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningbo, China
    • Fuming Street Community Health Service Center
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Qianhu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM-assisted community management; Participants received a multicomponent CGM-assisted community management strategy comprising a CGM device with a mobile application and clinician-facing data platform, structured training for community providers, one-to-one patient education and device demonstration, 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.	Device: Yuwell Anytime CT3A Continuous Glucose Monitoring System; A continuous glucose monitoring system with a paired mobile application and backend platform that enabled real-time glucose-data upload and clinician review. Participants were scheduled to wear the CGM sensor for 14 days at weeks 0, 8, and 16.; Other: CGM-Assisted Community Management Strategy; A structured community management strategy comprising provider training, one-to-one patient education, glucose-pattern interpretation, dietary and physical-activity advice, medication-management advice, and post-wear clinical review.
No Intervention: Usual community care; Blood Glucose Monitoring Method Maintain Traditional Self-Monitoring of Blood Glucose (SMBG): Continue using existing traditional blood glucose monitoring methods throughout the 24-week trial period.Monitoring Flexibility:No restrictions on the frequency or method of daily home blood glucose measurements; No restrictions on the type of traditional blood glucose monitoring devices used Patients can perform blood glucose monitoring according to personal habits and physician recommendations.; Medical Management Routine Medical Care: The control group's routine medication and treatment are not restricted by the study. Treatment Adjustments: During the trial period, patients and physicians can make adjustments at any time based on actual blood glucose control status, including: Medication adjustments; Dietary modifications; Exercise modifications Non-Intervention Principle: This study does not intervene in any of the above adjustments but requires detailed recording of all changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated hemoglobin (HbA1c) at 24 weeks	HbA1c was measured in venous blood at the central laboratory. The primary effect measure was the adjusted between-group mean difference in 24-week HbA1c, with adjustment for baseline HbA1c and prespecified baseline covariates. HbA1c is reported as a percentage, with lower values indicating better glycaemic control.	24 weeks
Implementation outcomes	Reach Proportion of registered adults with type 2 diabetes at the participating sites who received the CGM-assisted management strategy during the study implementation period.; Adoption Proportion of invited community health institutions participating in the study and proportion of intervention providers completing the structured training programme.; Implementation Fidelity Proportion of initiated CGM wear cycles yielding at least 7 valid days of sensor data, and proportion of intervention participants completing valid first, second, and third wear cycles.; Incremental Delivery Cost Incremental per-participant cost of delivering the CGM-assisted management strategy from the health-care provider perspective, including sensors, transmitters, printed materials, provider time, and provider training.; Maintenance Completion of the scheduled management pathway, stated willingness to continue CGM use at week 24, and continuation of CGM-related services after study completion.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range (TIR)	Time in Range (TIR): percentage of time glucose levels are within target range (3.9-10.0 mmol/L). Measurement method: Continuous glucose monitoring data analysis using CGM device (Anytime CT3A system). Assessment period: Three 2-week CGM wearing periods at weeks 0, 8, and 16.	Three 2-week CGM wearing periods at weeks 0, 8, and 16
Health-Related Quality of Life composite	Measurement tool: EQ-5D-5L questionnaire, including: EQ-5D-5L descriptive system (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression); EQ VAS (visual analogue scale, 0-100 scale). Assessment timing: Baseline and 24-week endpoint.	At baseline and 24-week endpoint
Treatment Costs	Cost components: Direct medical costs: CGM device costs, glucose monitoring supplies, outpatient visits, laboratory tests, medications; Healthcare resource utilization: frequency of hospital visits, emergency department visits, hypoglycemia-related healthcare contacts; Data collection: Patient self-report, medical records, and healthcare claims data; Assessment timing: Continuous throughout 24-week study period.	Continuous assessment from baseline through 24-week endpoint
Fasting plasma glucose (FPG)	Fasting plasma glucose was measured in venous blood at the central laboratory and compared between the two management groups with adjustment for baseline fasting plasma glucose and prespecified covariates.	24 weeks
Willingness to continue CGM use	Mean score on the five-point willingness-to-continue item among intervention-group participants completing the week-24 questionnaire; higher scores indicate greater willingness to continue CGM use.	24 weeks
CGM satisfaction score	Mean total score on the 20-item CGM satisfaction scale among scoreable intervention-group respondents; scores range from 1 to 5, with higher scores indicating greater satisfaction.	24 weeks
HbA1c Response	Proportion of participants with a reduction in HbA1c of at least 0·5 percentage points and at least 1·0 percentage point from baseline to week 24.	24 weeks
HbA1c Target Attainment	Proportion of participants with week-24 HbA1c below 7·0%, 7·5%, and 8·0%.	24 weeks
Body-Mass Index	Body-mass index at 24 weeks, calculated as weight in kilograms divided by height in metres squared.	24 weeks
Lipid Profile	Low-density lipoprotein cholesterol and triglyceride concentrations at 24 weeks, with total cholesterol and high-density lipoprotein cholesterol assessed as additional lipid outcomes.	24 weeks
Behavioural Changes	Self-reported dietary and physical-activity changes between baseline and week 24.	24 weeks
Glucose-Lowering Medication Changes	Changes in glucose-lowering medication classes between baseline and week 24, including initiation, discontinuation, and change in the number of medication classes.	24 weeks

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): July 31, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Primary care; Continuous glucose monitoring; Community diabetes care; Type 2 effectiveness-implementation hybrid study
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB00001052-24080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available because the participant consent and institutional data-governance approvals did not include public sharing of individual-level health data. The study protocol, statistical analysis plan, data dictionary, and analytic code may be available from the corresponding author upon reasonable request and subject to institutional approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No