Type 1 Diabetes Trial, Recruiting NCT07185555 Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT07185555
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have had a diagnosis of type 1 diabetes or autoimmune diabetes for at least 12 months
  • People with a body mass index (BMI) of 30 or higher (a measure of body weight relative to height)
  • People whose average blood sugar level (HbA1c) is below 9%
  • People who already know how to count carbohydrates in their meals and do so regularly
  • People who have been using an Advanced Hybrid Closed Loop (AHCL) insulin delivery system for at least 3 months and are willing to continue using it throughout the study
  • People who have had at least one diabetes specialist appointment in the past 12 months, including by video or phone
  • People who are willing to buy and use the meal replacement products required for the full duration of the study

Who may not be able to join:

  • People who have had a serious blood sugar emergency — such as diabetic ketoacidosis, a severe low blood sugar episode involving seizures or loss of consciousness, or dangerously high blood sugar requiring a hospital stay — in the past 6 months
  • People who have had a fever or illness in the past 2 weeks
  • People with dietary restrictions or food intolerances that would make the study's required food supplies unsuitable for them
  • People who have coeliac disease, a condition affecting stomach emptying (gastroparesis), or food allergies
  • People who do intense physical exercise for more than 2 hours on more than 3 days per week
  • People with a history of or known risk of an eating disorder, or other mental health conditions
  • People who use recreational drugs or drink alcohol heavily
  • People with chronic kidney disease where kidney function is significantly reduced (confirm with trial site)
  • People who have gallstones
  • People with liver failure
  • People who have had a serious heart condition — such as severe heart failure, unstable chest pain, a heart rhythm problem, a heart attack, or a stroke — in the past 12 months
  • People with respiratory (breathing) failure
  • People with severe or active infections
  • People who have planned surgery scheduled during the study period
  • People with certain rare inherited metabolic conditions (including porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defects, or pyruvate carboxylase deficiency)
  • People who are currently pregnant or are actively trying to become pregnant
  • People who are currently breastfeeding
  • People currently taking corticosteroid (glucocorticoid) medications, except those on a stable low dose, inhaled forms, or replacement therapy for adrenal insufficiency
  • People with other serious medical conditions that the trial doctors consider may interfere with completing the study
  • People who the trial team determines are unable or unwilling to complete the full study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Registry
ClinicalTrials.gov
Start date
16 January 2025
Est. completion
14 December 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Change in body weight from baseline to end of 4-week Very Low-Energy Ketogenic Therapy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov