Psychological Aspects and Insulin Pump Therapy
Psychological Aspects and Continuous Subcutaneous Insulin Infusion in Type 1 Diabetic Adults.
1 other identifier
observational
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 14, 2014
May 1, 2014
1.6 years
May 12, 2014
May 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline glycosylated haemoglobin (HbA1c) at 6th, 12th and 24th months after transition to CSII.
Glycosylated haemoglobin (HbA1c) is a lab test that shows the average level of blood glucose over the previous 3 months. HbA1c is used in the present study as measure of the glycaemic control: it will be assessed at baseline, after 6, 12 and 24 months.
Baseline, 6, 12 and 24 months
Secondary Outcomes (10)
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.
Baseline, 6, 12, 24 months
Change from baseline glucose variability as measured by the Low Blood Glucose Index (%LBGI) at 6th, 12th and 24th months after transition to CSII.
Baseline, 6, 12, 24 months
Change from baseline glucose variability as measured by High Blood Glucose Index (%HBGI) at 6th, 12th and 24th months after transition to CSII.
Baseline, 6, 12, 24 months
Change from baseline depressive symptoms at 6th,12th and 24th months (BDI-II score)
Baseline, 6, 12, 24 months
Change from baseline anxiety symptoms at 6th,12th and 24th months (BAI score)
Baseline, 6, 12, 24 months
- +5 more secondary outcomes
Study Arms (1)
T1D patients on CSII
Patients affected by Type 1 Diabetes on insulin pump therapy
Eligibility Criteria
Outpatient setting
You may qualify if:
- Type 1 Diabetes
- Transition to CSII
- Age \>18 years
You may not qualify if:
- Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Endocrinology, Diabetes and Metabolism-Department of Medicine-AOUI Verona
Verona, 37126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maddalena Trombetta, MD Phd
AOUI Verona
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 14, 2014
Study Start
September 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2016
Last Updated
May 14, 2014
Record last verified: 2014-05