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Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

RecruitingPhase 4Ages 18 Years - 30 YearsAllUniversity of Campania Luigi Vanvitelli
NCT03463564 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the ad

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📋 Eligibility rules (as published)
Inclusion Criteria: * T1DM for at least 12 months * persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy, * recurrent severe hypoglycemic episodes or high glucose variability * willingness to wear the insulin pump Exclusion Criteria: * previous use of insulin pump * pregnancy or planning to become pregnant in the next 2 years, * lack of ability to use the study devices * history of severe chronic diseases * recent or concomitant use of corticosteroids * drug or alcohol abuse * psychiatric complaints that interfere with the correct use of the devices
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What it tests

  • Insulin pump
  • Insulin injections
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Where

1 site
Unit of Diabetes
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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