NCT03222245

The Effect of Injectable Therapies on Quality of Life in Diabetes

The Effect of Injectable Therapies on Health Status, Quality of Life and Treatment Satisfaction in Patients With Type 2 Diabetes: Prospective Observational Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 256 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. ADDQoL measures diabetes specific quality of life 2. DTSQ measures treatment satisfaction 3. SF-36 measures overall health status 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.

Detailed description

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: 1. ADDQoL measures diabetes specific quality of life 2. DTSQ measures treatment satisfaction 3. SF-36 measures overall health status 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.

Conditions

• Diabetes

Timeline

• Start date: 2017-06-30
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-07-19
• Last updated: 2023-04-07

Locations

1 site across 1 country: United Kingdom