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Can changing carb sources help tame blood sugar swings in type 1 diabetes?

NCT ID NCT06273631

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • First Affiliated Hospital, Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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