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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Insulin pump; Drug: Insulin injections

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Katherine Esposito; Phone Number: +390815665031; Email: katherine.esposito@unicampania.it

Study Locations

• Italy
  • Naples, Italy, 80138
    • Recruiting
    • Unit of Diabetes
    • Sub-Investigator: Maria Ida Maiorino
    • Sub-Investigator: Michela Petrizzo
    • Sub-Investigator: Giuseppe Bellastella
    • Contact: Katherine Esposito; Phone Number: +390815665031; Email: katherine.esposito@unicampania.it
    • Principal Investigator: Katherine Esposito

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin pump; Insulin Pump with rapid acting insulin analog lispro	Device: Insulin pump; Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.; Other Names: CSII
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	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; Other Names: MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c change	Within and between groups difference in HbA1c levels	Baseline, 6 months, 12 months, 24 months
Change in mean amplitude glucose excursions (MAGE	Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).	Baseline, 6 months, 12 months, 24 months
Change in coefficient of variation (CV)	Within and between groups difference in glucose variability measured as coefficient of variation (CV).	Baseline, 6 months, 12 months, 24 months
Change in standard deviation (SD) of mean glucose levels	Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels	Baseline, 6 months, 12 months, 24 months
Change in glucose variability	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	Baseline, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hypoglycemic events	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)	Through study completion, an average of 1 year
Change in weight		Baseline, 12 months, 24 months
Change in lipid profile	Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides	Baseline, 12 months, 24 months
Total daily insulin doses/Kg		Baseline, 12 months, 24 months
Diabetes treatment satisfaction	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).	Baseline, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Katherine Esposito, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: transition; CSII; type 1 diabetes; MDI; glycemic control; glucose variability
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 24012014-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No