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

Study Overview
=================
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.

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)

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Insulin pump
* Drug: Insulin injections


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin pump<br>Insulin Pump with rapid acting insulin analog lispro | Device: Insulin pump<br>* Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.<br>* Other names: CSII;|
| Active Comparator: Insulin injections<br>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<br>* 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<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, transition, CSII, MDI, glycemic control, glucose variability