Type 2 Diabetes (T2DM)NCT07097415
CGM-Assisted Community Management for Type 2 Diabetes
A study testing Yuwell Anytime CT3A Continuous Glucose Monitoring System and CGM-Assisted Community Management Strategy in people with Type 2 Diabetes (T2DM), run by Peking University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- Yuwell Anytime CT3A Continuous Glucose Monitoring System and CGM-Assisted Community Management Strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 2 sitesChina
- Study dates
- 15 Nov 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qianhu Hospital
Ningbo, Zhejiang
Fuming Street Community Health Service Center
Ningbo
About this study
Official title: 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.
Read more
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)
- Being tested
- Yuwell Anytime CT3A Continuous Glucose Monitoring System, CGM-Assisted Community Management Strategy
- Keywords
- Continuous glucose monitoring, Community diabetes care, Primary care, Type 2 effectiveness-implementation hybrid study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yuwell Anytime CT3A Continuous Glucose Monitoring SystemDevice
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 StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
HbA1c Target Attainment
Proportion of participants with week-24 HbA1c below 7·0%, 7·5%, and 8·0%.
Measured: 24 weeks
Body-Mass Index
Body-mass index at 24 weeks, calculated as weight in kilograms divided by height in metres squared.
Measured: 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.
Measured: 24 weeks
Behavioural Changes
Self-reported dietary and physical-activity changes between baseline and week 24.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Nov 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Sun, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097415
- Sponsor's protocol ID
- IRB00001052-24080
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring-assisted Management for Type 2 Diabetes in Chinese Community Care: a Non-randomised Pragmatic Type 2 Effectiveness-Implementation Hybrid Study
- ClinicalTrials.gov ID
- NCT07097415
- Acronym / sponsor ID
- IRB00001052-24080
- Conditions
- Type 2 Diabetes (T2DM)
- Keywords
- Continuous glucose monitoring, Community diabetes care, Primary care, Type 2 effectiveness-implementation hybrid study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM-assisted community management | Experimental | Device: Yuwell Anytime CT3A Continuous Glucose Monitoring System, Other: CGM-Assisted Community Management StrategyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older. ②A diagnosis of type 2 diabetes recorded in the electronic medical record for at least 1 year before screening.
Key exclusion criteria (5 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yuwell Anytime CT3A Continuous Glucose Monitoring SystemA 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. | Device | CGM-assisted community management |
| CGM-Assisted Community Management StrategyA 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. | Other | CGM-assisted community management |
Primary outcome
Glycosylated hemoglobin (HbA1c) at 24 weeks
Time frame: 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
Time frame: 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.
12 secondary outcomes
Fasting plasma glucose (FPG)
Time frame: 24 weeks
Willingness to continue CGM use
Time frame: 24 weeks
Time in Range (TIR)
Time frame: Three 2-week CGM wearing periods at weeks 0, 8, and 16
Health-Related Quality of Life composite
Time frame: At baseline and 24-week endpoint
Treatment Costs
Time frame: Continuous assessment from baseline through 24-week endpoint
CGM satisfaction score
Time frame: 24 weeks
HbA1c Response
Time frame: 24 weeks
HbA1c Target Attainment
Time frame: 24 weeks
Body-Mass Index
Time frame: 24 weeks
Lipid Profile
Time frame: 24 weeks
Behavioural Changes
Time frame: 24 weeks
Glucose-Lowering Medication Changes
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yuwell Anytime CT3A Continuous Glucose Monitoring System and CGM-Assisted Community Management Strategy in people with Type 2 Diabetes (T2DM), run by Peking University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1c) at 24 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.