Continuous Glucose Monitoring-assisted Management for Type 2 Diabetes in Chinese Community Care: a Non-randomised Pragmatic Type 2 Effectiveness-Implementation Hybrid Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 599
- 试验地点
- 4
- 主要终点
- Glycosylated hemoglobin (HbA1c) at 24 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Yuwell Anytime CT3A Continuous Glucose Monitoring System (Device)
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.
干预措施: CGM-Assisted Community Management Strategy (Other)
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. 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.
结局指标
主要结局
Glycosylated hemoglobin (HbA1c) at 24 weeks
时间窗: 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.
Implementation outcomes
时间窗: 24 weeks
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.
glycosylated hemoglobin
时间窗: At baseline and 24-week endpoint
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.
次要结局
- Health-Related Quality of Life composite(At baseline and 24-week endpoint)
- Time in Range (TIR)(Three 2-week CGM wearing periods at weeks 0, 8, and 16)
- Treatment Costs(Continuous assessment from baseline through 24-week endpoint)
- Fasting plasma glucose (FPG)(24 weeks)
- Willingness to continue CGM use(24 weeks)
- CGM satisfaction score(24 weeks)
- HbA1c Response(24 weeks)
- HbA1c Target Attainment(24 weeks)
- Body-Mass Index(24 weeks)
- Lipid Profile(24 weeks)
- Behavioural Changes(24 weeks)
- Glucose-Lowering Medication Changes(24 weeks)
- Fasting plasma glucose (FPG)(At baseline and 24-week endpoint)
- Healthcare Provider and Participant Awareness and Acceptance of CGM(at weeks 0, 8, 16, and 24 during the 24-week study period)
- Time in Range (TIR)(Three 2-week CGM wearing periods at weeks 0, 8, and 16)
- Standard Deviation (SD)(Three 2-week CGM wearing periods at weeks 0, 8, and 16)
- Mean Amplitude of Glycemic Excursion (MAGE)(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)
研究者
Feng Sun
associate professor
Peking University