Diabetes MellitusCONVERTNCT06587438
Effect of CGM on Glucose Control in Non-insulin-treated Patients With Type 2 Diabetes Mellitus
A study testing Sinocare iCan I3 CGM and Sinocare jinzhi+Blood glucose meter in people with Diabetes Mellitus, run by Sinocare at 6 sites in China.
Trial summary
The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sinocare iCan I3 CGM and Sinocare jinzhi+Blood glucose meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 6 sitesChina
- Study dates
- 17 Jan 2025to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
- (2)Patients diagnosed with type 2 diabetes
- (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
- (4)Subjects voluntarily sign an informed consent form
Who cannot join
- (1)Patients treated with insulin within 3 months prior to screening
- (2)Currently or have used a CGM device within 3 months prior to enrollment
- (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
- (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
- (5)Those who are participating or will participate in other clinical trials
- (6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
The Eighth Affiliated Hospital of Southern Medical University
Shunde, Guangdong
Renmin Hospital of Wuhan University （Hubei General Hospital）
Wuhan, Hubei, 430060
About this study
Official title: Effects of COntinuous Glucose moNitoring Versus Usual Care on glycEmic Control in Non-insulin-tReated Adults With Type 2 Diabetes：a Multi-center Randomized Controlled Trial
The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- Sinocare iCan I3 CGM, Sinocare jinzhi+Blood glucose meter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinocare iCan I3 CGMDevice
Real-time Continuous glucose monitoring
Sinocare jinzhi+Blood glucose meterDevice
Self-monitoring of blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Real-time Continuous glucose monitor | Experimental | In the first two weeks of every four-week period, rt-CGM is used to monitor blood glucose levels, while in the latter two weeks, SBMG is employed for usual care Receives: Device: Sinocare iCan I3 CGM |
| Self-monitoring of blood glucose | Active comparator | Using SMBG for usual care only. Receives: Device: Sinocare jinzhi+Blood glucose meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.
Measured: From enrollment to the end of the 24-week intervention period.
Secondary outcomes (1)
HbA1c & CGM
- Proportion of participants in each group achieving HbA1c < 7.0% at Week 24.
- Proportion of participants in each group achieving a reduction in HbA1c of ≥0.5% from baseline at Week 24.
- Change from baseline in Time in Range (TIR, %) defined as blood glucose within 3.9-10 mmol/L at Week 24, between the two groups.
- Change from baseline in Time in Target Range (TITR, %) defined as blood glucose within 3.9-7.8 mmol/L at Week 24, between the two groups.
- Change from baseline in Time Above Range (TAR, %) defined as blood glucose >10 mmol/L at Week 24, between the two groups.
- Change from baseline in Time Below Range (TBR, %) defined as blood glucose <3.9 mmol/L at Week 24, between the two groups.
- Change from baseline in Mean Sensor Glucose (MSG, mmol/L) at Week 24, between the two groups.
- Change from baseline in Coefficient of Variation (CV, %) at Week 24, between the two groups.
Measured: From enrollment to the end of the 24-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Jan 2025
- Primary completion14 Mar 2026
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587438
- Sponsor's protocol ID
- SN-CGM-PO-001
- Acronym
- CONVERT
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COntinuous Glucose moNitoring Versus Usual Care on glycEmic Control in Non-insulin-tReated Adults With Type 2 Diabetes：a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06587438
- Acronym / sponsor ID
- CONVERT / SN-CGM-PO-001
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- SinocareIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time Continuous glucose monitor | Experimental | Device: Sinocare iCan I3 CGMIn the first two weeks of every four-week period, rt-CGM is used to monitor blood glucose levels, while in the latter two weeks, SBMG is employed for usual care |
| Self-monitoring of blood glucose | Active comparator | Device: Sinocare jinzhi+Blood glucose meterUsing SMBG for usual care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
- (2)Patients diagnosed with type 2 diabetes
- (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
- (4)Subjects voluntarily sign an informed consent form
Key exclusion criteria (6 listed)
- (1)Patients treated with insulin within 3 months prior to screening
- (2)Currently or have used a CGM device within 3 months prior to enrollment
- (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
- (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
- (5)Those who are participating or will participate in other clinical trials
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 |
|---|---|---|
| Sinocare iCan I3 CGMReal-time Continuous glucose monitoring | Device | Real-time Continuous glucose monitor |
| Sinocare jinzhi+Blood glucose meterSelf-monitoring of blood glucose | Device | Self-monitoring of blood glucose |
Primary outcome
HbA1c
Time frame: From enrollment to the end of the 24-week intervention period.
Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.
1 secondary outcome
HbA1c & CGM
Time frame: From enrollment to the end of the 24-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinocare iCan I3 CGM and Sinocare jinzhi+Blood glucose meter in people with Diabetes Mellitus, run by Sinocare at 6 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
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?
HbA1c (time frame: From enrollment to the end of the 24-week intervention period.). 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 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.