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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This study is only open to sites in the Wessex CRN. The aim of diabetes treatment is to achieve and maintain as optimal blood glucose levels as possible to prevent unpleasant symptoms associated with high blood sugars and long-term complications of diabetes. This can be achieved with oral tablets, subcutaneous injectable diabetes therapies such as insulin or GLP-1 analogues.
Injectable therapies can significantly improve glucose control, but the counter to this might be an increased treatment burden, patient and clinician's inertia to initiate injectable treatments and the potential side effects of the medications.
These treatment aspects may critically affect patients' health related quality of life and satisfaction with treatment which can powerfully influence patients' compliance and self-management behaviours. This is an observational cohort study and its overall aim is to compare the health status, quality of life (QOL) and treatment satisfaction in two cohorts of patients with type 2 diabetes - those treated with oral diabetes drugs (nonexposed group) and those on subcutaneous injectable therapies (exposed group).
The changes in the above parameters will be measured by applying three questionnaires to both groups of participants at baseline and after 6 months of treatment:
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
The aim of diabetes treatment is to achieve and maintain as optimal blood glucose levels as possible to prevent unpleasant symptoms associated with high blood sugars and long-term complications of diabetes. This can be achieved with oral tablets, subcutaneous injectable diabetes therapies such as insulin or GLP-1 analogues.
Injectable therapies can significantly improve glucose control, but the counter to this might be an increased treatment burden, patient and clinician's inertia to initiate injectable treatments and the potential side effects of the medications.
These treatment aspects may critically affect patients' health related quality of life and satisfaction with treatment which can powerfully influence patients' compliance and self-management behaviours. This is an observational cohort study and its overall aim is to compare the health status, quality of life (QOL) and treatment satisfaction in two cohorts of patients with type 2 diabetes - those treated with oral diabetes drugs (nonexposed group) and those on subcutaneous injectable therapies (exposed group).
The changes in the above parameters will be measured by applying three questionnaires to both groups of participants at baseline and after 6 months of treatment:
Study duration is six months for each participant and over this period participants will receive three telephone or face to face contacts (based on their preference) with the research team. The questionnaires will be posted to participants at baseline and at 6 months and will be completed in paper form and returned to research team in pre-paid selfaddressed envelopes.
It is hoped that this study will provide valuable understanding of the effect of injectable therapies on QOL and treatment satisfaction in our local population with type 2 diabetes which can then be carefully factored into clinical decisions when initiating or intensifying diabetes treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | This group consists of participants identified as needing to start injectable therapy within 1 month from the recruitment date (50% insulin and 50% GLP-1 analogues) | ||
| Non-exposed group | This group consists of participants treated with oral anti- hyperglycaemic agents (OAHAs) and their combinations |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Change in ADDQoL score Change in DTSQ score | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Local population of patients with type 2 diabetes from both the primary and secondary care setting.
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Allard | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospital NHS Trust | Portsmouth | UK | PO6 3LY | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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