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

Type 1 Diabetes Mellitus Clinical Trial

— METRO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463564
• Other study ID #: 24012014-33
• Status: Recruiting
• Phase: Phase 4
• First received: February 19, 2018
• Last updated: March 13, 2018
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: March 2018
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Katherine Esposito
• Phone: +390815665031
• Email: katherine.esposito[@]unicampania.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Italy	Unit of Diabetes	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change	Within and between groups difference in HbA1c levels	Baseline, 6 months, 12 months, 24 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change in weight		Baseline, 12 months, 24 months
Secondary	Change in lipid profile	Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides	Baseline, 12 months, 24 months
Secondary	Total daily insulin doses/Kg		Baseline, 12 months, 24 months
Secondary	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