Avoidance of Hyperglycaemia in People With Type 1 Diabetes

NCT04732780 | Completed Results

• 1 other identifier: 20SM6251
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes; Hyperglycaemia; Psychology

Outcome Measures

Primary Outcomes (7)

• Hyperglycaemia Avoidance Scale

  Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance

  Baseline

• General Anxiety Disorder-7 (GAD-7)

  Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety

  Baseline

• Patient Health Questionnaire 9 (PHQ-9)

  Questionnaire. Scored 0-27, with higher scores suggesting greater depression

  Baseline

• State Trait Anxiety Inventory - Trait Subscale

  Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety

  Baseline

• 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

• Problem Areas in Diabetes 5

  Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress.

  Baseline

• 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

Study Arms (1)

Questionnaire group

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Questionnaire group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes under the care of Imperial College Healthcare NHS Trust

You may qualify if:

• Type 1 diabetes of at least 6 months duration

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Imperial Health Charity: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr Vicky McKechnie
• Organization: Imperial College London

vicky.mckechnie@nhs.net

02083830689

Study Officials

• Nick Oliver

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: March 2, 2021
• Primary Completion: November 15, 2021
• Study Completion: April 20, 2022
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)