Can changing carb sources help tame blood sugar swings in type 1 diabetes?
NCT ID NCT06273631
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study looks at whether changing the types of carbohydrates people with type 1 diabetes eat can improve blood sugar control. Researchers will compare a diet with more whole grains and beans to one with mostly refined grains. 80 adults will be monitored to see if the diverse carb diet leads to more time with blood sugar in a healthy range.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- diverse carbohydrate diet vs moderate carbohydrate diet
- What this could lead to
- If successful, this could show that adjusting the type of carbohydrates in meals helps people with type 1 diabetes manage their blood sugar more steadily.
- What could go wrong
- This is a small, early-stage dietary study with 80 participants. Results may not apply to everyone, and diet changes can be hard to maintain long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants who agree to participate in the study and provide written informed consent; 2. Diagnosed with type 1 diabetes mellitus according to the ADA 2024 criteria; 3. Aged 18 to 70 years, inclusive; 4. Receiving exogenous insulin therapy with a stable treatment regimen for at least 2 months before enrollment (the type of insulin should remain unchanged, while the dose may be adjusted according to blood glucose levels); 5. Body mass index (BMI) between 18.0 and 25.0 kg/m², inclusive; 6. Glycated hemoglobin A1c (HbA1c) \<11%. Exclusion Criteria: 1. Type 1 diabetes mellitus in the honeymoon phase; 2. Pregnant or breastfeeding women, or women for whom pregnancy cannot be ruled out; 3. Patients who are vegetarians or are undergoing weight loss; 4. Patients who are users of oral hypoglycemic drugs (alpha-glucosidase inhibitors, DPP-4 inhibitors, etc.); 5. Use of glucocorticoids within 30 days before enrollment; 6. History of severe food allergy; 7. Patients with acute complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) within the previous 6 months; 8. Patients with gastroparesis, inflammatory bowel disease or other complications; 9. Patients with macroalbuminuria (albumin-to-creatinine ratio \> 34 mg/mmol) or renal insufficiency (creatinine \> 200 μmol/L); 10. Patients with uncontrolled hyperthyroidism or hypothyroidism (Uncontrolled hyperthyroidism is defined as abnormal TSH and FT4. Uncontrolled hypothyroidism is defined as TSH \> 10 mIU/L.); 11. History of heart disease, coronary artery disease or arrhythmia; 12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal; 13. History of malignant tumors; history of tumors or surgery affecting digestion or nutrient absorption. Eligibility of participants with a history of benign tumors will be determined by the investigator; 14. Patients with other uncontrolled immune system diseases or uncontrolled infections; 15. Alcohol abuse, drug abuse, mental disorders, or other conditions unsuitable for study participation; 16. Any disease or condition that, in the investigator's judgment, may interfere with study participation or evaluation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital, Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210029, China
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