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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Imperial Health Charity | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire group | Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperglycaemia Avoidance Scale | Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance | Baseline |
| General Anxiety Disorder-7 (GAD-7) | Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety | Baseline |
| Patient Health Questionnaire 9 (PHQ-9) | Questionnaire. Scored 0-27, with higher scores suggesting greater depression | Baseline |
| State Trait Anxiety Inventory - Trait Subscale | Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety | 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. | Baseline |
| Problem Areas in Diabetes 5 | Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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People with type 1 diabetes under the care of Imperial College Healthcare NHS Trust
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| Name | Affiliation | Role |
|---|---|---|
| Nick Oliver | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hyperglycaemia Avoidance Scale | Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
Participants spent approximately one hour completing questionnaires
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vicky McKechnie | Imperial College London | 02083830689 | vicky.mckechnie@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2021 | Aug 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Primary | General Anxiety Disorder-7 (GAD-7) | Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Primary | Patient Health Questionnaire 9 (PHQ-9) | Questionnaire. Scored 0-27, with higher scores suggesting greater depression | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Primary | State Trait Anxiety Inventory - Trait Subscale | Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Problem Areas in Diabetes 5 | Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 0 |
| 253 |
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| 253 |
| 0 |
| 253 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |