Diabetes Mellitus, Type 2NCT05824286
HbA1c Prediction Model in Patients With Type 2 Diabetes
A study testing HbA1c prediction in people with Diabetes Mellitus, Type 2, run by Peking University People's Hospital at 1 site in China.
Trial summary
Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HbA1c prediction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 30 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
- Have HbA1c results within 4 weeks, and the range was 7.5-11%;
- Willing and able to conduct self-glucose monitoring;
- Have not participated in any other research program in the past 4 weeks.
Who cannot join
- Type 1 diabetes mellitus;
- Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
- Diabetic ketosis in the last 1 week;
- Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
- Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
- Pregnancy or breastfeeding;
- Receiving chemotherapy or radiation therapy;
- Have a severe mental illness and cannot complete the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Ch, 100044
Zhou Xianghai
About this study
Official title: Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HbA1c prediction
- Keywords
- Blood Glucose Self-Monitoring, HbA1c Prediction Model, Ridge Regression
- 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.
HbA1c predictionOther
HbA1c prediction model was developed based on fasting capillary blood glucose and postprandial capillary blood glucose from self-monitoring blood glucose. Since HbA1c was measured once every 3 month, self-monitoring blood glucose records were transferred to predicted HbA1c by prediction model every month.
| Study group | Role | What they receive |
|---|---|---|
| HbA1c prediction model group | Experimental | HbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month. Receives: Other: HbA1c prediction |
| Conventional treatment group | No intervention | Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured HbA1c from baseline to 24 weeks
Measured: 24 weeks
Secondary outcomes (5)
Change in measured HbA1c from baseline to 12 weeks
Measured: 12 weeks
The percentages of participants with HbA1c less than 7.0% at 12 weeks
Measured: 12 weeks
The percentages of participants with HbA1c less than 7.0% at 24 weeks
Measured: 24 weeks
Change in weight from baseline to 24 weeks
Measured: 24 weeks
The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study
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 posted21 Apr 2023
- Study start4 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianghai Zhou, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824286
- Sponsor's protocol ID
- RDL2022-30
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05824286
- Acronym / sponsor ID
- RDL2022-30
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Blood Glucose Self-Monitoring, HbA1c Prediction Model, Ridge Regression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Apr 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.
Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HbA1c prediction model group | Experimental | Other: HbA1c predictionHbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month. |
| Conventional treatment group | No intervention | –Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
- Have HbA1c results within 4 weeks, and the range was 7.5-11%;
- Willing and able to conduct self-glucose monitoring;
- Have not participated in any other research program in the past 4 weeks.
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus;
- Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
- Diabetic ketosis in the last 1 week;
- Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
- Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
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 |
|---|---|---|
| HbA1c predictionHbA1c prediction model was developed based on fasting capillary blood glucose and postprandial capillary blood glucose from self-monitoring blood glucose. Since HbA1c was measured once every 3 month, self-monitoring blood glucose records were transferred to predicted HbA1c by prediction model every month. | Other | HbA1c prediction model group |
Primary outcome
Change in measured HbA1c from baseline to 24 weeks
Time frame: 24 weeks
5 secondary outcomes
Change in measured HbA1c from baseline to 12 weeks
Time frame: 12 weeks
The percentages of participants with HbA1c less than 7.0% at 12 weeks
Time frame: 12 weeks
The percentages of participants with HbA1c less than 7.0% at 24 weeks
Time frame: 24 weeks
Change in weight from baseline to 24 weeks
Time frame: 24 weeks
The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HbA1c prediction in people with Diabetes Mellitus, Type 2, run by Peking University People's Hospital at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Xianghai, Prof. (010-88324371, xianghai_zhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measured HbA1c from baseline to 24 weeks (time frame: 24 weeks). 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 21 Apr 2023.