Insulin Pump Versus Insulin Injections in Young Adults With Type 1 Diabetes
Compares an insulin pump with daily insulin injections in young adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
Key facts
- Where
- Naples, ItalySee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 30 years old?
Source: NCT03463564, who can take part
Where in Italy
- Unit of DiabetesNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Campania Luigi Vanvitelli
- Trial code
- NCT03463564
- Record updated
- 15 March 2018
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: previous use of insulin pump; recent or concomitant use of corticosteroids; drug or alcohol abuse; history of severe chronic diseases; psychiatric complaints that interfere with the correct use of the devices; pregnancy or planning to become pregnant in the next 2 years,; lack of ability to use the study devices.