Psychological Aspects and Insulin Pump Therapy

University of Verona

Status: Unknown

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT02138188

ISP-DT1-ITA13 (CE-2393)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 Diabetes
• Transition to CSII
• Age >18 years

Exclusion criteria

• Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
• Pregnancy

Trial design

36 participants in 1 patient group

T1D patients on CSII

Description:

Patients affected by Type 1 Diabetes on insulin pump therapy