DiabetesPhase 4NCT04562454
An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets
A Phase 4 study testing Specific diet in people with Diabetes, run by Peking Union Medical College Hospital.
Trial summary
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Specific diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2021
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
- Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire
Who cannot join
- severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
- serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
- patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
- patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
- patients with mental illness, confusion and inability to take care of themselves;
- patients with gastrointestinal diseases;
- patients or their families cannot understand the conditions and objectives of this study
Trial locations and contacts
No sites are listed yet.
About this study
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). GI is currently widely used to provide guidance on food choices for people with diabetes. However, there are great differences in blood glucose response among different individuals after eating the same food, which is related to a variety of factors，including individual gastrointestinal digestion and absorption rate,islet function,insulin resistance and region. A large number of foreign studies suggest that race affects the determination of GI, but different regions of our country have different dietary culture and different ability to digest and absorb different foods. Therefore, the traditional GI reference value does not necessarily fully reflect the blood glucose response of diabetic patients after eating a food. In this study, continuous blood glucose monitoring was carried out through CGM to monitor the overall fluctuation level of blood glucose, the time to peak and the range of blood glucose fluctuation after eating specific foods, and to obtain individual GI, after eating different diets to guide the future diet.
Read the detailed description
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the subjects. And try to find the best time and dose of hypoglycemic strategy for subjects during meals. At the same time, during the follow-up period, we observed whether the subjects could achieve better blood glucose control after adjusting their diet according to the GI of different foods. At the same time, the GI results of the same food were compared between people with normal glucose metabolism and those with abnormal glucose metabolism.
- Conditions
- Diabetes
- Being tested
- Specific diet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific dietOther
use a specific diet in different days with CGM to konw GI of different food in diabetes
| Study group | Role | What they receive |
|---|---|---|
| Normal group | Experimental | Specific diet with CGM for 5days Receives: Other: Specific diet |
| T1DM group | Experimental | Specific diet with CGM for 5days Receives: Other: Specific diet |
| T2DM group | Experimental | Specific diet with CGM for 5days Receives: Other: Specific diet |
| other type of diabetes group | Experimental | Specific diet with CGM for 5days Receives: Other: Specific diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluctuation of blood glucose after eating different food
use the CGM to get the area under the curve of blood glucose of different food
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weigang Zhao, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562454
- Sponsor's protocol ID
- 20200920-JS-2450
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- 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 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets
- ClinicalTrials.gov ID
- NCT04562454
- Acronym / sponsor ID
- 20200920-JS-2450
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 24 Sep 2020 (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 glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). GI is currently widely used to provide guidance on food choices for people with diabetes. However, there are great differences in blood glucose response among different individuals after eating the same food, which is related to a variety of factors，including individual gastrointestinal digestion and absorption rate,islet function,insulin resistance and region. A large number of foreign studies suggest that race affects the determination of GI, but different regions of our country have different dietary culture and different ability to digest and absorb different foods. Therefore, the traditional GI reference value does not necessarily fully reflect the blood glucose response of diabetic patients after eating a food. In this study, continuous blood glucose monitoring was carried out through CGM to monitor the overall fluctuation level of blood glucose, the time to peak and the range of blood glucose fluctuation after eating specific foods, and to obtain individual GI, after eating different diets to guide the future diet.
Detailed description
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the subjects. And try to find the best time and dose of hypoglycemic strategy for subjects during meals. At the same time, during the follow-up period, we observed whether the subjects could achieve better blood glucose control after adjusting their diet according to the GI of different foods. At the same time, the GI results of the same food were compared between people with normal glucose metabolism and those with abnormal glucose metabolism.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal group | Experimental | Other: Specific dietSpecific diet with CGM for 5days |
| T1DM group | Experimental | Other: Specific dietSpecific diet with CGM for 5days |
| T2DM group | Experimental | Other: Specific dietSpecific diet with CGM for 5days |
| other type of diabetes group | Experimental | Other: Specific dietSpecific diet with CGM for 5days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
- Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire
Key exclusion criteria (7 listed)
- severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
- serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
- patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
- patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
- patients with mental illness, confusion and inability to take care of themselves;
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 |
|---|---|---|
| Specific dietuse a specific diet in different days with CGM to konw GI of different food in diabetes | Other | Normal group, T1DM group, T2DM group, other type of diabetes group |
Primary outcome
fluctuation of blood glucose after eating different food
Time frame: baseline
use the CGM to get the area under the curve of blood glucose of different food
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- 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.
Weigang Zhao, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Specific diet in people with Diabetes, run by Peking Union Medical College Hospital.
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 2 inclusion and 7 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weigang Zhao, MD (+86 69151876, xiehezhaoweigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluctuation of blood glucose after eating different food (time frame: baseline). 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 24 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.