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)

Overview

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.

Interventions

• 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

Primary outcome measures

• HbA1c change [Time frame: Baseline, 6 months, 12 months, 24 months]
• Change in mean amplitude glucose excursions (MAGE [Time frame: Baseline, 6 months, 12 months, 24 months]
• Change in coefficient of variation (CV) [Time frame: Baseline, 6 months, 12 months, 24 months]
• Change in standard deviation (SD) of mean glucose levels [Time frame: Baseline, 6 months, 12 months, 24 months]
• Change in glucose variability [Time frame: Baseline, 6 months, 12 months, 24 months]

Secondary outcome measures (5)

• Occurrence of hypoglycemic events [Time frame: Through study completion, an average of 1 year]
• Change in weight [Time frame: Baseline, 12 months, 24 months]
• Change in lipid profile [Time frame: Baseline, 12 months, 24 months]
• Total daily insulin doses/Kg [Time frame: Baseline, 12 months, 24 months]
• Diabetes treatment satisfaction [Time frame: Baseline, 12 months, 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Unit of Diabetes — Naples

Identifiers

NCT: NCT03463564 · 24012014-33

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗