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NCT Number: NCT03463564

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unit of Diabetes

Naples, 80138, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin pump

Device

Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.

Other names: CSII

Insulin injections

Drug

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

Other names: MDI

Primary outcomes

  1. HbA1c change

    Time frame: Baseline, 6 months, 12 months, 24 months

    Within and between groups difference in HbA1c levels

  2. Change in mean amplitude glucose excursions (MAGE

    Time frame: Baseline, 6 months, 12 months, 24 months

    Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).

  3. Change in coefficient of variation (CV)

    Time frame: Baseline, 6 months, 12 months, 24 months

    Within and between groups difference in glucose variability measured as coefficient of variation (CV).

  4. Change in standard deviation (SD) of mean glucose levels

    Time frame: Baseline, 6 months, 12 months, 24 months

    Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels

  5. Change in glucose variability

    Time frame: Baseline, 6 months, 12 months, 24 months

    Within and between groups difference in time in the euglycemic range, defined as the minutes per day spent in glucose levels ranging between 70-180 mg/dL

Secondary outcomes

  1. Occurrence of hypoglycemic events

    Time frame: Through study completion, an average of 1 year

    Number of events of mild hypoglycemia (glucose levels below 70 mg/dl), or severe hypoglycemia (below 54 mg/dl or each episode of low glucose levels requiring assistance)

  2. Change in weight

    Time frame: Baseline, 12 months, 24 months

  3. Change in lipid profile

    Time frame: Baseline, 12 months, 24 months

    Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

  4. Total daily insulin doses/Kg

    Time frame: Baseline, 12 months, 24 months

  5. Diabetes treatment satisfaction

    Time frame: Baseline, 12 months, 24 months

    In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time).

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Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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)

Acronym: METRO

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2018
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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