NCT02138188

Psychological Aspects and Insulin Pump Therapy

Psychological Aspects and Continuous Subcutaneous Insulin Infusion in Type 1 Diabetic Adults.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological distress and some psychological factors might be predictors of metabolic control; however, very few studies conducted so far were specifically focused on the psychological aspects of CSII therapy in adults affected by T1DM.

Detailed description

The aim of this project is to study the psychological effect of Continuous Subcutaneous Insulin Infusion (CSII) in a cohort of type 1 diabetic patients and to explore the influence of psychological factors (coping style, locus of control, self-efficacy) on glycaemic control. A sample of 36 type 1 diabetic patients will be recruited at Endocrinology, Diabetes and Metabolism Division of Verona City Hospital. Among T1DM patients routinely followed by our Institution the study will be proposed to those starting the CSII therapy based on the inclusion and exclusion criteria. Each study participants will provide a written informed consent and will undergo a set of 4 psychological evaluation assessing depression, anxiety, self-efficacy, perceived interference caused by diabetes, family support, locus of control and coping strategies on top of routine medical examination and laboratory testing for outcome measures at baseline and after 6, 12 and 24 months after study entry.

Conditions

• Type 1 Diabetes

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-04-01
• Completion: 2016-04-01
• First posted: 2014-05-14
• Last updated: 2014-05-14

Locations

1 site across 1 country: Italy