Very low-energy ketogenic program for adults with type 1 diabetes and obesity using an automated insulin system
Applying Very Low Calorie Ketogenic Diet to the Treatment of Obesity in People With Type 1 Diabetes on Intensive Insulin Therapy Using Automated Insulin Delivery System
This will test whether a 4-week very low-energy ketogenic diet delivered with meal replacements can help adults with type 1 diabetes and obesity who use an advanced hybrid closed‑loop insulin system lose weight safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Academic / other |
| Locations | 1 site (Bari, Italy) |
| Trial ID | NCT07185555 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with established type 1 diabetes (≥12 months), BMI ≥30 kg/m², HbA1c <9%, experienced in carbohydrate counting, using an AHCL system for ≥3 months, and willing to follow a prescribed meal‑replacement ketogenic program are ideal candidates.
Not a fit: People with recent diabetic ketoacidosis or severe hypoglycemia, chronic kidney disease (eGFR <60 ml/min), active eating disorders or incompatible dietary restrictions, gastroparesis, recent febrile illness, or those not using an AHCL system are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a rapid, supervised weight-loss option for adults with type 1 diabetes and obesity that improves weight and metabolic markers while using closed‑loop insulin systems to lower some safety risks.
How similar studies have performed: Very‑low‑energy and ketogenic diets have proven effective for weight loss in obesity and type 2 diabetes, but evidence in type 1 diabetes is limited and safety concerns have previously constrained testing, with closed‑loop insulin systems now offering a safer context for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bari, Italy
- University Hospital Policlinico Consorziale — Bari, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.