Diabetes Mellitus, Type 1HYPENCT04732780

Avoidance of Hyperglycaemia in People With Type 1 Diabetes

An observational study of Diabetes Mellitus, Type 1, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
How many people: 253 participants
Where: 1 siteUnited Kingdom
Study dates: 2 Mar 2021to 20 Apr 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

Type 1 diabetes of at least 6 months duration

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College Healthcare NHS Trust
London

Other trials in United Kingdom

About this study

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
Being tested: No intervention
Keywords: Diabetes, Hyperglycaemia, Psychology
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT04732780
Study group	Role	What they receive
Questionnaire group		Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202120 Apr 2022

First posted1 Feb 2021
Study start2 Mar 2021
Primary completion15 Nov 2021
Study completion20 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04732780
Sponsor's protocol ID: 20SM6251
Acronym: HYPE
Status last verified: Aug 2023
First submitted: 27 Jan 2021
Last updated: 25 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Avoidance of Hyperglycaemia in People With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04732780
Acronym / sponsor ID: HYPE / 20SM6251
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes, Hyperglycaemia, Psychology
Study type: Observational
Recruitment status: Completed
Enrolment: 253 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: Imperial College Healthcare NHS Trust, Imperial Health Charity
Study start: 2 Mar 2021 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 20 Apr 2022 (actual)
First posted: 1 Feb 2021 (actual)
Results: Posted 25 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Questionnaire group	–	Other: No interventionIndividuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: People with type 1 diabetes under the care of Imperial College Healthcare NHS Trust

Key inclusion criteria (1 listed)

Type 1 diabetes of at least 6 months duration

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention	Other	Questionnaire group

Primary outcome

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

Results and safety

Results posted to the registry on 25 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Questionnaire Group	253	253

Primary outcome: Hyperglycaemia Avoidance Scale

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Questionnaire Group n = 253
Value	44.6 (12.6)

Primary outcome: General Anxiety Disorder-7 (GAD-7)

Time frame: Baseline. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Questionnaire Group n = 253
Value	4 (1 to 9)

Primary outcome: Patient Health Questionnaire 9 (PHQ-9)

Time frame: Baseline. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Questionnaire Group n = 253
Value	5 (1 to 10)

Primary outcome: State Trait Anxiety Inventory - Trait Subscale

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Questionnaire Group n = 253
Value	42.4 (12.5)

Adverse events

Time frame: Participants spent approximately one hour completing questionnaires. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Questionnaire Group	0 of 253 (0%)	0 of 253 (0%)	0 of 253

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 2
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Metastatic Colorectal Cancer
Not yet recruiting
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nick Oliver principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hyperglycaemia Avoidance Scale (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04732780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.