Clinical trial NCT02138188: Psychological Aspects and Insulin Pump Therapy
Official title: Psychological Aspects and Continuous Subcutaneous Insulin Infusion in Type 1 Diabetic Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient setting

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes
* Transition to CSII
* Age \>18 years

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline glycosylated haemoglobin (HbA1c) at 6th, 12th and 24th months after transition to CSII.
timeFrame: Baseline, 6, 12 and 24 months
Secondary outcomes:
measure: Change from baseline glucose variability as measured by standard deviation (SD) and coefficient of variation (CV) of capillary blood glucose test [mg/dL] at 6th, 12th and 24th months after transition to CSII.
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline glucose variability as measured by the Low Blood Glucose Index (%LBGI) at 6th, 12th and 24th months after transition to CSII.
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline glucose variability as measured by High Blood Glucose Index (%HBGI) at 6th, 12th and 24th months after transition to CSII.
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline depressive symptoms at 6th,12th and 24th months (BDI-II score)
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline anxiety symptoms at 6th,12th and 24th months (BAI score)
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline general perceptions of diabetes at 6th, 12th and 24th months (MDQ Section 1 score)
timeFrame: Baseline, 6, 12, 24 months
measure: Change from baseline family support at 6th, 12th and 24th months (MDQ section II score)
timeFrame: Baseline, 6, 12 and 24 months
measure: Change from baseline Diabetes Self-Efficacy at 6th, 12th and 24th months (MDQ section III score)
timeFrame: Baseline, 6, 12, 24 months
measure: Determination of Health Locus of Control (MHLC) at Baseline
timeFrame: Baseline
measure: Measures of Coping Strategies at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Division of Endocrinology, Diabetes and Metabolism-Department of Medicine-AOUI Verona
Study officials:
affiliation: AOUI Verona
name: Maddalena Trombetta, MD Phd
role: PRINCIPAL_INVESTIGATOR
References: