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)

Who is this study for? Young adult patients with Type 1 Diabetes
What treatments are being studied? Insulin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Unit of Diabetes
RECRUITING
Naples
Contact Information
Primary
Katherine Esposito
katherine.esposito@unicampania.it
+390815665031
Time Frame
Start Date: 2016-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Active_comparator: Insulin pump
Insulin Pump with rapid acting insulin analog lispro
Active_comparator: 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 at bed-time of basal insulin glargine or degludec
Related Therapeutic Areas
Sponsors
Leads: University of Campania Luigi Vanvitelli

This content was sourced from clinicaltrials.gov

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