Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes

April 15, 2026 updated by: Yang Tao
The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1. Main Objective: To evaluate the effect of changes of carbohydrate intake on glucose control in patients with type 1 diabetes.

  1. Primary endpoint: difference of time in range (TIR) between the 2 groups.
  2. Secondary endpoint:

1) difference of coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE) , large amplitude of glycemic excursions (LAGE) between the 2 groups; 2) difference of change in HbA1c，GA，1,5-anhydroglucitol (1,5-AG) from baseline between the 2 groups; 3) difference of change in incidence of hypoglycemic events (%), severe hypoglycemia and nocturnal hypoglycemia events from baseline between the 2 groups; 4) difference of change in insulin dose (IU/kg/day) from baseline between the 2 groups.

2. Secondary objective: To explore the possible mechanism of dietary intervention to improve blood glucose control in patients with type 1 diabetes.

  1. Effects of dietary intervention on intestinal microenvironment and microflora of type 1 diabetes patients;
  2. Effects of dietary intervention on immune function of type 1 diabetes patients;
  3. Effects of dietary intervention on metabolomics of type 1 diabetes patients.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital, Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Those who agree to participate in the study and sign informed consent;
  2. Diagnosis of type 1 diabetes mellitus (ADA2024);
  3. Age of 18~70 years;
  4. Dependent on exogenous insulin therapy, the treatment plan remains unchanged within 2 months (the type of insulin cannot be changed, and the dose can be adjusted according to plasma glucose);
  5. Body mass index (BMI) of 18~25kg/m2;
  6. HbA1c ≤11%;

Exclusion Criteria:

  1. Honeymooners with type 1 diabetes mellitus;
  2. Women who are pregnant or plan to become pregnant;
  3. Patients who are vegetarians or are undergoing weight loss;
  4. Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-IV inhibitors, etc.);
  5. Patients who are users of glucocorticoids within 30 days;
  6. History of severe food allergy;
  7. Patients with acute complications such as DKA or HHS within six months;
  8. Patients with gastroparesis, inflammatory bowel disease and other complications;
  9. Patients with large albuminuria(albumin-to-creatinine ratio>34.09mg/mmol) and renal insufficiency(creatinine>200umol/L);
  10. Patients with uncontrolled hyperthyroidism and hypothyroidism(Uncontrolled hyperthyroidism is defined as abnormal TSH and T4. Uncontrolled hypothyroidism is defined as TSH > 10mIU/L.);
  11. History of heart disease, coronary heart disease and arrhythmia;
  12. Serious of liver dysfunction (ALT or AST>3 times the upper limit of normal);
  13. History of malignant tumors; History of tumors or surgeries affecting digestion and nutrient absorption; Patients with a history of benign tumors, which is judged by the physician to be not suitable;
  14. Patients with uncontrolled other immune system diseases or uncontrolled infections;
  15. Alcohol abuse, drug abuse, mental disorders or other conditions unfit to be an observer in drug tests;
  16. Patients with any disease likely to interfere with study participation or evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diverse carbohydrate diet

Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 45~50% of carbohydrate supply sources are refined grains, 45~50% of carbohydrate supply sources are whole grains or beans.

The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%，and dinner 30~35%.
Other: diverse carbohydrate diet

Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 45~50% of carbohydrate supply sources are refined grains, 45~50% of carbohydrate supply sources are whole grains or beans.

The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%，and dinner 30~35%.
Other: moderate carbohydrate diet

Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25~35%. 90~95% of the carbohydrate supply comes from refined grains.

The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%，and dinner 30~35%.
Other: moderate carbohydrate diet

Carbohydrate provides 45~55% of total dietary energy, protein 15~20%, and fat 25 ~35%. Among them, 90~95% of carbohydrate supply sources are refined grains.

The total energy is divided into 3 meals per day. The breakfast provides 25~30% of total energy, lunch 30~40%，and dinner 30~35%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (TIR)
Time Frame: Baseline to 2 weeks
TIR represents percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L based on CGMS. TIR will be compared between the 2 interventions.
Baseline to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GA（glycosylated albumin）from baseline
Time Frame: Baseline to 2 weeks
Reflect 2~3 weeks of glycemic control
Baseline to 2 weeks
Change in HbA1c from baseline
Time Frame: Baseline to 14 weeks
Reflect 2~3 months of glycemic control
Baseline to 14 weeks
Change in 1,5-anhydroglucitol (1,5-AG) from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Reflect 1~2 weeks of glycemic control
Baseline to 2 weeks and to 14 weeks
Change in total insulin dose from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Baseline to 2 weeks and to 14 weeks
Change in blood lipids from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Baseline to 2 weeks and to 14 weeks
Change in body weight from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Baseline to 2 weeks and to 14 weeks
Change in Incidence of hypoglycemic events from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Reflects the safety of clinical trials
Baseline to 2 weeks and to 14 weeks
Change in gut microbiota from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Baseline to 2 weeks and to 14 weeks
Change in metabolomics from baseline
Time Frame: Baseline to 2 weeks and to 14 weeks
Baseline to 2 weeks and to 14 weeks
Change in autoimmunity from baseline
Time Frame: Baseline to 14 weeks
Baseline to 14 weeks
Coefficient of variation of blood glucose（CV）
Time Frame: Baseline to 2 weeks
Reflect glucose fluctuation
Baseline to 2 weeks
Mean amplitude of glycemic excursions（MAGE）
Time Frame: Baseline to 2 weeks
Reflect glucose fluctuation
Baseline to 2 weeks
Large amplitude of glycemic excursions (LAGE)
Time Frame: Baseline to 2 weeks
Reflect glucose fluctuation
Baseline to 2 weeks
Time above range(TAR)
Time Frame: Baseline to 2 weeks
TAR represents percentage of time of glucose levels spent over 10.0 mmol/L based on CGMS. TAR will be compared between the 2 interventions.
Baseline to 2 weeks
Time below range(TBR)
Time Frame: Baseline to 2 weeks
TBR represents percentage of time of glucose levels spent below 3.9 mmol/L based on CGMS. TBR will be compared between the 2 interventions.
Baseline to 2 weeks
Daily mean glucose values
Time Frame: Baseline to 2 weeks
Baseline to 2 weeks
Number of participants with severe hypoglycemia and nocturnal hypoglycemia events
Time Frame: Baseline to 2 weeks and to 14 weeks
Reflects the safety of clinical trials
Baseline to 2 weeks and to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yang Tao

Investigators

  • Principal Investigator: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SR-481.A2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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