Trial Outcomes & Findings for Avoidance of Hyperglycaemia in People With Type 1 Diabetes (NCT NCT04732780)

NCT ID: NCT04732780

Last Updated: 2023-08-25

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 253 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-08-25

Participant Flow

Participant milestones

Measure	Questionnaire Group Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Overall Study STARTED	253
Overall Study COMPLETED	253
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Age, Continuous	48.7 years STANDARD_DEVIATION 15.8 • n=253 Participants
Sex: Female, Male Female	150 Participants n=253 Participants
Sex: Female, Male Male	103 Participants n=253 Participants
Region of Enrollment United Kingdom	253 Participants n=253 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Hyperglycaemia Avoidance Scale	44.6 score on a scale Standard Deviation 12.6

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
General Anxiety Disorder-7 (GAD-7)	4 score on a scale Interval 1.0 to 9.0

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Patient Health Questionnaire 9 (PHQ-9)	5 score on a scale Interval 1.0 to 10.0

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
State Trait Anxiety Inventory - Trait Subscale	42.4 score on a scale Standard Deviation 12.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Hypoglycaemia Fear Survey 2 - Behaviour Subscale	17.2 score on a scale Standard Deviation 8.2

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Problem Areas in Diabetes 5	8 score on a scale Standard Deviation 4.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Questionnaire Group n=253 Participants Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. No intervention: No intervention
Hypoglycaemia Fear Survey 2 - Worry Subscale	26.1 score on a scale Standard Deviation 13.7

Adverse Events

Questionnaire Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Vicky McKechnie

Imperial College London

Phone: 02083830689

Email: vicky.mckechnie@nhs.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place