HYPE: Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT04732780

Collaborator

Imperial College Healthcare NHS Trust (Other), Imperial Health Charity (Other)

253

Enrollment

Location

13.6

Actual Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

253 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Actual Study Start Date :

Mar 2, 2021

Actual Primary Completion Date :

Nov 15, 2021

Actual Study Completion Date :

Apr 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Questionnaire group Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey.	Other: No intervention No intervention
Questionnaire and interview group Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. Approximately 16 individuals who experience avoidance of hyperglycaemia will then take part in a semi-structured interview.	Other: No intervention No intervention

Arm

Intervention/Treatment

Questionnaire group

Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey.

Other: No intervention

No intervention

Questionnaire and interview group

Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. Approximately 16 individuals who experience avoidance of hyperglycaemia will then take part in a semi-structured interview.

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Hyperglycaemia Avoidance Scale [Baseline]
Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance
GAD-7 [Baseline]
Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety
PHQ-9 [Baseline]
Questionnaire. Scored 0-27, with higher scores suggesting greater depression
State Trait Anxiety Inventory [Baseline]
Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety
Hypoglycaemia Fear Survey 2 [Baseline]
Questionnaire. Behaviour subscale scored 0-60; Worry subscale scored 0-72, in both cases with higher scores suggesting greater fear of hypoglycaemia
Problem Areas in Diabetes 5 [Baseline]
Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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