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OpenTrials
Completed

NCT Number: NCT04732780

Avoidance of Hyperglycaemia in People With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Hyperglycaemia Avoidance Scale

    Time frame: Baseline

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

  2. General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

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

  3. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: Baseline

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

  4. State Trait Anxiety Inventory - Trait Subscale

    Time frame: Baseline

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

  5. Hypoglycaemia Fear Survey 2 - Behaviour Subscale

    Time frame: 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.

  6. Problem Areas in Diabetes 5

    Time frame: Baseline

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

  7. Hypoglycaemia Fear Survey 2 - Worry Subscale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • Imperial Health Charity

Registry information

Acronym: HYPE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 1, 2021
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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