RECRUITINGPhase 4INTERVENTIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Insulin pump

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

DRUG

Insulin 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

Locations (1)

Unit of Diabetes

Naples, Italy