Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations

NCT ID: NCT07117188

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-04-01

Brief Summary

This study aims to observe the differences in postprandial blood glucose fluctuations in patients with type 2 diabetes and healthy individuals after consuming different dietary recipes through a prospective cohort study, in order to optimize individualized dietary strategies.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetes cohort

No interventions assigned to this group

Non-diabetic cohort

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• For diabetes cohort:

1. diagnosed with type 2 diabetes is more than one month

2. Glycated hemoglobin (HbA1c) : 6.5%<HbA1c<10.5%(48 mmol/mol < HbA1c < 91.3 mmol/mol)

3. Requirements for the blood glucose management plan: Within one month before the start of the trial, a simple lifestyle, and/or one or more oral hypoglycemic drugs (metformin, DPP-4 inhibitors, SGLT-2 inhibitors, TZD drugs, GLP-1 receptor agonists), and/or basal insulin treatment once a day were adopted, and the regimen was required to be maintained stably within 7 days before the start of the trial and during the trial.

4. Take the test voluntarily and sign the informed consent form.

• For Non-diabetic cohort:

1. Glycated hemoglobin (HbA1c) : HbA1c<5.7%

2. Fasting blood glucose was between 3.9 and 5.6 mmol/L, and 2-hour postprandial blood glucose was less than 7.8mmol/L

3. Take the test voluntarily and sign the informed consent form.

Exclusion Criteria

1. Skin damage, scars, redness and swelling at the wearing site, or those with subcutaneous edema at the wearing site of an infected person, or those allergic to disinfectants, medical adhesive tapes or patches.

2. Epilepsy or cognitive impairment, immunosuppressive disorders, and systemic neurological diseases.

3. Required emergency or inpatient treatment due to severe hypoglycemia (blood glucose < 3.0mmol/L with consciousness disorder), diabetic ketoacidosis, or non-ketotic hyperosmolar syndrome in the past six months.

4. Severe circulatory disorders.

5. Long-term gastrointestinal diseases (such as celiac disease, gastroparesis, etc.), or eating disorders or having undergone bariatric surgery (such as gastric bypass surgery); Has a history of severe infection within the past month; History of malignant tumors (except skin cancer); Mental illnesses such as depression; Severe liver and kidney dysfunction (renal function: estimated eGFR<30mL/min or maintenance dialysis required;) Liver function: ALT and AST>3 times the upper limit of the normal value or active liver disease. History of severe cardiovascular disease (NYHA cardiac function classification III-IV or BNP >400 pg/mL).

6. Technical or language barriers: Inability to use research applications or understand text; Unable to cooperate with the use of research equipment such as continuous blood glucose monitors and accelerometers.

7. Drug use: Immunosuppressants, proton pump inhibitors, or steroid drugs have been used in the past 4 weeks or are planned to be used during the study period.

8. BMI<16.5 kg/m².

9. Magnetic resonance imaging (MRI) examination is planned or conducted within 16 days of product use.

10. Pregnant and lactating women, and those planning to become pregnant during the study period.

11. Those whom the researchers consider unsuitable to participate in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United Imaging Healthcare

UNKNOWN

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Fudan University

Shanghai, , China

Countries

China

Central Contacts

Ying Chen

Role: CONTACT

chen.ying4@zs-hospital.sh.cn

086+19542806360

Facility Contacts

Ying Chen

Role: primary

chen.ying4@zs-hospital.sh.cn

086+19542806360

Other Identifiers

20250519040454800

Identifier Type: -

Identifier Source: org_study_id