Very low-energy ketogenic program for adults with type 1 diabetes and obesity using an automated insulin system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm feasibility trial testing a 4-week Very Low‑Energy Ketogenic Therapy (600–800 kcal/day, <30 g/day carbohydrates) delivered via commercial meal replacements under close medical supervision. Participants must have type 1 diabetes for at least 12 months, BMI ≥30 kg/m², HbA1c <9%, and be using an Advanced Hybrid Closed Loop (AHCL) insulin system for at least 3 months. Primary outcome is change in body weight at 4 weeks, with secondary measures including body composition, muscle strength, glucose metrics, insulin requirements, laboratory safety parameters, and patient-reported outcomes. Safety monitoring includes frequent glucose checks, capillary ketone monitoring, and surveillance for hypoglycemia and diabetic ketoacidosis while insulin is adjusted as needed through the AHCL system.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age ≥ 18 years

Diagnosis of type 1 diabetes or autoimmune diabetes for ≥ 12 months

BMI ≥ 30 kg/m²

HbA1c \< 9%

Knowledge and use of carbohydrate counting

Use of an Advanced Hybrid Closed Loop (AHCL) system for ≥ 3 months and willingness to maintain it during the study

At least 1 diabetology follow-up visit in the last 12 months (including telemedicine)

Willingness to purchase meal replacements for the entire study duration

Exclusion Criteria:

Ketoacidosis, severe hypoglycemia with seizures/coma, or severe hyperglycemia requiring hospitalization in the last 6 months

Febrile illness within the last 2 weeks

Dietary restrictions or intolerances incompatible with study food supplies

Celiac disease, gastroparesis, food allergies

Intense physical exercise \>2 hours on \>3 days per week

History or risk of eating disorder, or other psychiatric disorders

Recreational drug use or excessive alcohol consumption

Chronic kidney disease (eGFR \<60 ml/min)

Gallstones

Liver failure

Heart failure (NYHA III-IV), unstable angina, cardiac arrhythmia, myocardial infarction, or stroke within the last 12 months

Respiratory failure

Severe or active infections

Planned elective surgery

Rare metabolic diseases (porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, pyruvate carboxylase defect)

Pregnancy (current or actively trying to conceive)

Breastfeeding

Current glucocorticoid therapy (except stable low-dose, inhaled, or replacement for adrenal insufficiency)

Other serious medical conditions that might interfere with participation or study completion in the investigator's judgment

Participant judged unable or unwilling to complete the study

Where it's running

• University Hospital Policlinico Consorziale
  Bari, Italy, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.