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This study investigates the effectiveness and implementation of continuous glucose monitoring (CGM) technology for type 2 diabetes management in Chinese community healthcare settings. Type 2 diabetes represents a significant public health challenge in China, with traditional blood glucose monitoring methods presenting limitations including patient discomfort, incomplete glucose data, and delayed information transmission to healthcare providers. CGM devices offer continuous, real-time glucose monitoring with the potential to improve patient outcomes and healthcare delivery efficiency.
This quasi-experimental pragmatic trial employs an effectiveness-implementation Type II hybrid design, enrolling 800 adults with type 2 diabetes from two community health centers in Yinzhou District, Ningbo. Participants are randomly assigned to either a CGM intervention group or a control group using traditional self-monitoring blood glucose methods. The CGM group receives device training and wears CGM systems for three separate 2-week periods over 24 weeks, while the control group continues standard monitoring practices. The primary outcome is change in glycated hemoglobin (HbA1c) levels, with secondary outcomes including other metabolic markers, patient satisfaction, and quality of life measures. Simultaneously, the study explores implementation factors using the Consolidated Framework for Implementation Research (CFIR) through qualitative interviews with healthcare providers and quantitative surveys with patients. This comprehensive approach aims to provide evidence for CGM effectiveness in Chinese patients while identifying barriers and facilitators for successful implementation in community healthcare settings, ultimately informing strategies for improving diabetes management at the population level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Group | Experimental | (1) individualized health education sessions conducted by endocrinology healthcare providers covering CGM concepts, usage methods, advantages, risks, and precautions, along with hands-on device demonstration and provision of written materials and user manuals; (2) development of an integrated CGM data management platform that connects with community healthcare information systems for real-time data transmission, storage, and analysis; (3) establishment of standardized CGM response protocols for healthcare providers, including glucose target setting, dietary and exercise recommendations, personalized medication adjustments based on glucose fluctuations, and management procedures for hypoglycemic and hyperglycemic alerts; and (4) mobile application setup and data transmission configuration for patients. |
|
| control group | No Intervention |
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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous blood glucose monitoring assisted blood glucose management | Device | (1) individualized health education sessions conducted by endocrinology healthcare providers covering CGM concepts, usage methods, advantages, risks, and precautions, along with hands-on device demonstration and provision of written materials and user manuals; (2) development of an integrated CGM data management platform that connects with community healthcare information systems for real-time data transmission, storage, and analysis; (3) establishment of standardized CGM response protocols for healthcare providers, including glucose target setting, dietary and exercise recommendations, personalized medication adjustments based on glucose fluctuations, and management procedures for hypoglycemic and hyperglycemic alerts; and (4) mobile application setup and data transmission configuration for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| glycosylated hemoglobin | Measurement method: Laboratory blood test analysis. Assessment timing: At baseline and at 24-week endpoint. Procedure: Venous blood samples collected by clinical physicians, processed at hospital laboratory facilities. | At baseline and 24-week endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose (FPG) | Measurement method: Laboratory blood test analysis. Assessment timing: At baseline and 24-week endpoint. | At baseline and 24-week endpoint |
| Healthcare Provider and Participant Awareness and Acceptance of CGM |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianhu Hospital | Ningbo | Zhejiang | China | |||
| Fuming Street Community Health Service Center |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Measurement method: Custom-designed structured questionnaires. Assessment timing: Baseline, follow-up visits, and endpoint.
Questionnaires used:
| at weeks 0, 8, 16, and 24 during the 24-week study period |
| 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 |
| Standard Deviation (SD) | 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 |
| Mean Amplitude of Glycemic Excursion (MAGE) | 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 |
| Ningbo |
| China |
| D004700 | Endocrine System Diseases |