Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin injectionsDevice: Insulin pump
- Registration Number
- NCT03463564
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin injections 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 Insulin pump Insulin pump Insulin Pump with rapid acting insulin analog lispro
- Primary Outcome Measures
Name Time Method Change in mean amplitude glucose excursions (MAGE Baseline, 6 months, 12 months, 24 months Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).
HbA1c change Baseline, 6 months, 12 months, 24 months Within and between groups difference in HbA1c levels
Change in glucose variability 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
Change in coefficient of variation (CV) Baseline, 6 months, 12 months, 24 months Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Change in standard deviation (SD) of mean glucose levels Baseline, 6 months, 12 months, 24 months Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels
- Secondary Outcome Measures
Name Time Method Occurrence of hypoglycemic events 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)
Change in weight Baseline, 12 months, 24 months Total daily insulin doses/Kg Baseline, 12 months, 24 months Change in lipid profile Baseline, 12 months, 24 months Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Diabetes treatment satisfaction 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).
Trial Locations
- Locations (1)
Unit of Diabetes
🇮🇹Naples, Italy