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

University of Campania "Luigi Vanvitelli"

Status and phase: Enrolling; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin injections; Device: Insulin pump

Study type: Interventional

Funder types: Other

Identifiers

NCT03463564

24012014-33

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Insulin pump

Active Comparator group

Description:

Insulin Pump with rapid acting insulin analog lispro

Treatment:

Device: Insulin pump

Insulin injections

Active Comparator group

Description:

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

Treatment:

Drug: Insulin injections