Psychological Aspects and Insulin Pump Therapy

NCT ID: NCT02138188

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T1D patients on CSII

Patients affected by Type 1 Diabetes on insulin pump therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Maddalena Trombetta

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maddalena Trombetta, MD Phd

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona

Locations

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Division of Endocrinology, Diabetes and Metabolism-Department of Medicine-AOUI Verona

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Maddalena Trombetta, MD Phd

Role: primary

+39 045 8123110

Other Identifiers

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ISP-DT1-ITA13 (CE-2393)

Identifier Type: -

Identifier Source: org_study_id

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