Type 1 or Type 2 DiabetesNCT05995756
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring
An observational study of Type 1 or Type 2 Diabetes, run by Sinocare at 3 sites in China.
Trial summary
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 or Type 2 Diabetes
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 20 Dec 2021to 30 Jun 2022
- Phase
- Observational
- 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
Study population: Adult (Aged ≥18) TD1 and TD2
Who may be able to join
- Aged ≥18 years, male or female;
- Clinically diagnosed with diabetes;
- Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
- Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
Who cannot join
- Disagree to wear the investigational device continuously according to the requirements of the trial;
- Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
- Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
- With diffuse subcutaneous nodules at the wearing site of the investigational device;
- Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
- With mental disorders, lack of self-control and inability to express clearly;
- Have participated in any other clinical trial within the past 1 month;
- Where the investigator thinks not suitable for being enrolled.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Pinggu Hospital
Beijing
Peking University People's Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
About this study
Official title: Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).
- Conditions
- Type 1 or Type 2 Diabetes
- 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.
| Study group | Role | What they receive |
|---|---|---|
| In pateint | Not described | |
| Out pateint | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mean absolute relative difference (MARD)
Measured: 8 or 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start20 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 or Type 2 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995756
- Sponsor's protocol ID
- NPI031-CIP-001
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose
- ClinicalTrials.gov ID
- NCT05995756
- Acronym / sponsor ID
- NPI031-CIP-001
- Conditions
- Type 1 or Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SinocareIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Aug 2023 (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.
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In pateint | – | – |
| Out pateint | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (Aged ≥18) TD1 and TD2
Key inclusion criteria (4 listed)
- Aged ≥18 years, male or female;
- Clinically diagnosed with diabetes;
- Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
- Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).
Key exclusion criteria (8 listed)
- Disagree to wear the investigational device continuously according to the requirements of the trial;
- Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
- Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
- With diffuse subcutaneous nodules at the wearing site of the investigational device;
- Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall mean absolute relative difference (MARD)
Time frame: 8 or 15 days
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 1 Sep 2023.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 or Type 2 Diabetes, run by Sinocare at 3 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 8 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
overall mean absolute relative difference (MARD) (time frame: 8 or 15 days). 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 1 Sep 2023.