Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes, Hyperglycaemia, Psychology
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Imperial College Healthcare NHS Trust
Imperial Health Charity
Imperial College London
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycaemia Avoidance Scale | Baseline | Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance |
| General Anxiety Disorder-7 (GAD-7) | Baseline | Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety |
| Patient Health Questionnaire 9 (PHQ-9) | Baseline | Questionnaire. Scored 0-27, with higher scores suggesting greater depression |
| State Trait Anxiety Inventory - Trait Subscale | Baseline | Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety |
| Hypoglycaemia Fear Survey 2 - Behaviour Subscale | 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 | Baseline | Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress. |
| Hypoglycaemia Fear Survey 2 - Worry Subscale | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 253 |
| Total | 253 |
Baseline characteristics
| Characteristic | Questionnaire Group | — |
|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 15.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 253 Participants | — |
| Sex: Female, Male Female | 150 Participants | — |
| Sex: Female, Male Male | 103 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 253 |
| other Total, other adverse events | 0 / 253 |
| serious Total, serious adverse events | 0 / 253 |
Outcome results
Primary
General Anxiety Disorder-7 (GAD-7)
Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Questionnaire Group | General Anxiety Disorder-7 (GAD-7) | 4 score on a scale |
Primary
Hyperglycaemia Avoidance Scale
Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Questionnaire Group | Hyperglycaemia Avoidance Scale | 44.6 score on a scale | Standard Deviation 12.6 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Questionnaire Group | Hypoglycaemia Fear Survey 2 - Behaviour Subscale | 17.2 score on a scale | Standard Deviation 8.2 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Questionnaire Group | Hypoglycaemia Fear Survey 2 - Worry Subscale | 26.1 score on a scale | Standard Deviation 13.7 |
Primary
Patient Health Questionnaire 9 (PHQ-9)
Questionnaire. Scored 0-27, with higher scores suggesting greater depression
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Questionnaire Group | Patient Health Questionnaire 9 (PHQ-9) | 5 score on a scale |
Primary
Problem Areas in Diabetes 5
Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Questionnaire Group | Problem Areas in Diabetes 5 | 8 score on a scale | Standard Deviation 4.9 |
Primary
State Trait Anxiety Inventory - Trait Subscale
Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Questionnaire Group | State Trait Anxiety Inventory - Trait Subscale | 42.4 score on a scale | Standard Deviation 12.5 |