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)

Trial ID: NCT03463564

Interventional - Phase 4 - Recruiting

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Insulin pump
• Insulin injections

Eligibility

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

Sponsor

University of Campania Luigi Vanvitelli

Source: ClinicalTrials.gov

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