CGM-Assisted Community Management for Type 2 Diabetes

NCT07097415 | Completed

• 1 other identifier: IRB00001052-24080
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes (T2DM)

Keywords

Continuous glucose monitoring; Community diabetes care; Primary care; Type 2 effectiveness-implementation hybrid study

Outcome Measures

Primary Outcomes (2)

• 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

  1. 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. 2. Adoption Proportion of invited community health institutions participating in the study and proportion of intervention providers completing the structured training programme. 3. 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. 4. 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. 5. 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 Outcomes (12)

• Fasting plasma glucose (FPG)

  24 weeks

• Willingness to continue CGM use

  24 weeks

• Time in Range (TIR)

  Three 2-week CGM wearing periods at weeks 0, 8, and 16

• Health-Related Quality of Life composite

  At baseline and 24-week endpoint

• Treatment Costs

  Continuous assessment from baseline through 24-week endpoint

Study Arms (2)

CGM-assisted community management

EXPERIMENTAL

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; Other: CGM-Assisted Community Management Strategy

Usual community care

NO INTERVENTION

1. 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. 2. 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.

Interventions

Yuwell Anytime CT3A Continuous Glucose Monitoring System DEVICE

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.

CGM-assisted community management

CGM-Assisted Community Management Strategy OTHER

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.

CGM-assisted community management

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (2)

Qianhu Hospital

Ningbo, Zhejiang, China

Location

Fuming Street Community Health Service Center

Ningbo, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 31, 2025
• Study Start: November 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)