Clinical trial NCT03463564: Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
transition
CSII
MDI
glycemic control
glucose variability
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: HbA1c change
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in mean amplitude glucose excursions (MAGE
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in coefficient of variation (CV)
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in standard deviation (SD) of mean glucose levels
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in glucose variability
timeFrame: Baseline, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Occurrence of hypoglycemic events
timeFrame: Through study completion, an average of 1 year
measure: Change in weight
timeFrame: Baseline, 12 months, 24 months
measure: Change in lipid profile
timeFrame: Baseline, 12 months, 24 months
measure: Total daily insulin doses/Kg
timeFrame: Baseline, 12 months, 24 months
measure: Diabetes treatment satisfaction
timeFrame: Baseline, 12 months, 24 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Unit of Diabetes
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Katherine Esposito
role: PRINCIPAL_INVESTIGATOR
References: