Avoidance of Hyperglycaemia in People With Type 1 Diabetes (HYPE)

August 24, 2023 updated by: Imperial College London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperglycaemia Avoidance Scale
Time Frame: Baseline
Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance
Baseline
Problem Areas in Diabetes 5
Time Frame: Baseline
Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress.
Baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline
Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety
Baseline
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Baseline
Questionnaire. Scored 0-27, with higher scores suggesting greater depression
Baseline
State Trait Anxiety Inventory - Trait Subscale
Time Frame: Baseline
Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Imperial College Healthcare NHS Trust
Imperial Health Charity

Investigators

  • Principal Investigator: Nick Oliver, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20SM6251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe