Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: No intervention

• Registration Number: NCT04732780
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-01
• Study Start: 2021-03-02
• Primary Completion: 2021-11-15
• Study Completion: 2022-04-20
• Results First Submitted: 2022-08-30
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Results First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Questionnaire group	No intervention	Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9 (PHQ-9)	Baseline	Questionnaire. Scored 0-27, with higher scores suggesting greater depression
State Trait Anxiety Inventory - Trait Subscale	Baseline	Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety
Hypoglycaemia Fear Survey 2 - Behaviour Subscale	Baseline	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.
Hypoglycaemia Fear Survey 2 - Worry Subscale	Baseline	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.
Hyperglycaemia Avoidance Scale	Baseline	Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance
General Anxiety Disorder-7 (GAD-7)	Baseline	Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety
Problem Areas in Diabetes 5	Baseline	Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress.

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom