An interventional study of diverse carbohydrate diet and moderate carbohydrate diet in Type 1 Diabetes, Diet Intervention and Glucose Control, sponsored by Yang Tao. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Yang Tao · Not applicable, Interventional, and Treatment
This multicenter, randomized, controlled, open-label clinical trial aims to evaluate the effects of different carbohydrate intake patterns on glycemic control in adults with type 1 diabetes.
Participants will first complete a 2-week run-in period and will then be randomly assigned in a 1:1 ratio to one of two dietary groups. Both diets provide similar proportions of total energy from carbohydrates, protein, and fat, but differ in the sources of staple carbohydrates. In the moderate carbohydrate diet group, most staple foods are refined grains, whereas in the diverse carbohydrate diet group, approximately half of the staple foods are whole grains and legumes.
80 participants will follow the assigned dietary intervention for 2 weeks, followed by a 12-week follow-up period. The primary outcome is time in range (TIR), defined as the percentage of time that glucose levels are within the target range, measured using continuous glucose monitoring. Other measures of glycemic control, glycemic variability, insulin requirements, body measurements, metabolic indicators, and safety will also be evaluated. Exploratory analyses will assess potential changes in gut microbiota, immune function, and metabolomic profiles.
Medical nutrition therapy is an important component of the management of type 1 diabetes. In addition to the amount of carbohydrate consumed, the source and quality of dietary carbohydrates may influence glycemic responses and glycemic variability. However, evidence regarding the effects of different carbohydrate intake patterns in people with type 1 diabetes remains limited, particularly when glycemic outcomes are assessed using continuous glucose monitoring.
This study is designed to compare two dietary patterns that provide comparable total energy intake and the same target macronutrient distribution but differ in the sources of staple carbohydrates. Individual energy intake is determined according to each participant's estimated energy requirement. In both groups, carbohydrates provide 45%-55% of total energy, protein provides 15%-20%, and fat provides 25%-35%.
In the moderate carbohydrate diet (MCD) group, 90%-95% of staple foods are derived from refined grains. In the diverse carbohydrate diet (DCD) group, 45%-50% of staple foods are derived from refined grains and 45%-50% from whole grains and legumes. Thus, the principal difference between the two dietary patterns is the source and diversity of staple carbohydrates rather than total energy intake or overall macronutrient composition.
By minimizing differences in total energy intake and macronutrient distribution between the two groups, this study aims to evaluate whether changing the sources and diversity of dietary carbohydrates influences glycemic control and glycemic variability in people with type 1 diabetes.
In addition to clinical and metabolic assessments, exploratory analyses will evaluate changes in gut microbiota, immune function, and metabolomics to investigate potential mechanisms through which different carbohydrate intake patterns may affect glycemic control.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
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Exclusion Criteria:
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
Other: diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
Other: moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
Time in range (TIR)
TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM). TIR at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Time above range(TAR)
TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM). TAR at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Time below range(TBR)
TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM). TBR at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Mean glucose (MG)
Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period. Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Standard deviation of glucose (SD)
SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability. SD at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Glucose coefficient of variation (CV)
CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability. CV at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Mean amplitude of glycemic excursions (MAGE)
MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability. MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Largest amplitude of glycemic excursions (LAGE)
LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability. LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Glycated albumin (GA)
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization)
Glycated hemoglobin A1c (HbA1c)
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
Time frame: 16 weeks (14 weeks after randomization)
C-peptide area under the curve (AUC C-peptide)
C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule. The assessment will be performed in participants with fasting C-peptide \>80 pmol/L.
Time frame: 16 weeks (14 weeks after randomization)
Glucagon area under the curve (AUC glucagon)
Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule. The assessment will be performed in participants with fasting C-peptide \>80 pmol/L.
Time frame: 16 weeks (14 weeks after randomization)
Fasting blood glucose (FBG)
Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Total cholesterol (TC)
Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Triglycerides (TG)
Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Low-density lipoprotein cholesterol (LDL-C)
LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
High-density lipoprotein cholesterol (HDL-C)
HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
1,5-Anhydroglucitol (1,5-AG)
1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Total daily insulin dose
Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Basal insulin dose
Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Prandial insulin dose
Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Body weight
Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Waist circumference
Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Hip circumference
Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Waist-to-hip ratio (WHR)
Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Body composition
Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Hypoglycemic events
Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
Time frame: From randomization to the end of follow-up at 16 weeks
Diabetic ketoacidosis (DKA)
The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
Time frame: From randomization to the end of follow-up at 16 weeks
Gut microbiota profile
Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
Metabolomic profile
Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
T-cell subset proportions
The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
Time frame: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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