RecruitingPhase 4NCT03463564

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

Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)

Sponsor

University of Campania Luigi Vanvitelli

Enrollment

150 participants

Start Date

Jan 1, 2016

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

Summary

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 adult diabetes care.

Eligibility

Min Age: 18 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing insulin pump therapy (a small device worn on the body that delivers insulin continuously) versus multiple daily insulin injections in adults with Type 1 diabetes whose blood sugar is not well controlled, to see which approach works better for managing blood sugar levels. **You may be eligible if...** - You have had Type 1 diabetes for at least 12 months - Your HbA1c (a measure of average blood sugar) is 7.5% or higher despite good diabetes education and treatment - You have frequent severe low blood sugar episodes or very unpredictable blood sugar swings - You are willing to wear an insulin pump **You may NOT be eligible if...** - You have used an insulin pump before - You are pregnant or planning to become pregnant in the next 2 years - You have serious chronic illnesses - You have recently used or are using corticosteroid medications - You have issues with drug or alcohol use - You have psychiatric conditions that would prevent safe use of the study devices Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInsulin pump

Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.

DRUGInsulin injections

Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin