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NCT04732780 Clinical Trial

Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— HYPE  

Official title:
Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04732780
Other study ID # 20SM6251
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2021
Est. completion date April 20, 2022

Study information
Verified date August 2023
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to learn more about avoidance of hyperglycaemia in adults with type 1 diabetes. People who attend a type 1 diabetes clinic will be invited to complete a number of self-report questionnaires and a survey. A subsection of people who experience avoidance of hyperglycaemia will be invited to take part in an interview in order to gain a more in-depth understanding of this issue.

Recruitment information / eligibility
Status Completed
Enrollment 253
Est. completion date April 20, 2022
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Type 1 diabetes of at least 6 months duration Exclusion Criteria: - Inability to understand or write in the English language - Pregnant women - Unable to participate in the study due to other factors, as assessed by the Chief Investigators

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (3)
Lead Sponsor Collaborator
Imperial College London Imperial College Healthcare NHS Trust, Imperial Health Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hyperglycaemia Avoidance Scale Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance Baseline
Primary General Anxiety Disorder-7 (GAD-7) Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety Baseline
Primary Patient Health Questionnaire 9 (PHQ-9) Questionnaire. Scored 0-27, with higher scores suggesting greater depression Baseline
Primary State Trait Anxiety Inventory - Trait Subscale Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety Baseline
Primary Hypoglycaemia Fear Survey 2 - Behaviour Subscale Questionnaire. Behaviour subscale scored 0-60; Worry subscale scored 0-72, in both cases with higher scores suggesting greater fear of hypoglycaemia.
Please see outcome measure 7 for worry subscale results.		 Baseline
Primary Problem Areas in Diabetes 5 Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress. Baseline
Primary Hypoglycaemia Fear Survey 2 - Worry Subscale Questionnaire. Behaviour subscale scored 0-60; Worry subscale scored 0-72, in both cases with higher scores suggesting greater fear of hypoglycaemia
Please see outcome measure 5 for behaviour subscale results.		 Baseline
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