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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
599
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.
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.
Qianhu Hospital
Ningbo, Zhejiang, China
Fuming Street Community Health Service Center
Ningbo, China
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.
Time frame: 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.
Time frame: 24 weeks
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.
Time frame: 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.
Time frame: 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Continuous assessment from baseline through 24-week endpoint
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.
Time frame: 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.
Time frame: 24 weeks
HbA1c Target Attainment
Proportion of participants with week-24 HbA1c below 7·0%, 7·5%, and 8·0%.
Time frame: 24 weeks
Body-Mass Index
Body-mass index at 24 weeks, calculated as weight in kilograms divided by height in metres squared.
Time frame: 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.
Time frame: 24 weeks
Behavioural Changes
Self-reported dietary and physical-activity changes between baseline and week 24.
Time frame: 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.
Time frame: 24 weeks
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