A multicenter randomized clinical trial is underway to assess the effectiveness of a diabetes-educated psychologist in managing glucose levels and reducing diabetes distress in individuals with type 1 diabetes. The study seeks to determine whether psychological interventions can play a key role in supporting patients’ emotional and behavioral challenges related to their condition.
Introduction
Managing blood glucose levels and coping with the psychological strain of diabetes is an ongoing challenge for many individuals with type 1 diabetes. Diabetes-related stress, compounded by the disease’s behavioral demands, can significantly affect a patient’s ability to manage their condition effectively. This study investigates whether treatment with a psychologist educated in diabetes management can improve both glucose control and reduce diabetes distress.
Methods
The study involves individuals with a HbA1c greater than 62 mmol/mol (7.8%) who were randomly assigned to either a psychological treatment group or a control group. Participants will be monitored for a duration of 52 weeks. Those in the treatment group will engage with a diabetes-educated psychologist at least seven times during the study period. The research includes six outpatient diabetes units and ten psychologists. Cognitive behavioral therapy (CBT) is the primary treatment approach. Both groups will have regular appointments with a diabetes nurse and/or physician at the start of the study, and at 3, 6, and 12 months. Key measurements include HbA1c, blood pressure, and weight, with diabetes distress, quality of life, hypoglycemia confidence, and treatment satisfaction evaluated through questionnaires. The primary endpoint is the change in HbA1c from baseline to week 52. Secondary endpoints include changes in diabetes distress and quality of life, as well as treatment satisfaction at 52 weeks.
Discussion
This trial aims to advance our understanding of how psychological support can aid in the management of diabetes. Should the results indicate a significant impact on HbA1c levels or reductions in diabetes-related distress, it could pave the way for psychologists to be integrated more prominently into diabetes care teams. The findings may open up new avenues for managing the emotional and behavioral complexities of living with diabetes.
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