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ORIGINAL RESEARCH article
Front. Clin. Diabetes Healthc.
Sec. Diabetes Therapies
Volume 6 - 2025 | doi: 10.3389/fcdhc.2025.1549234
This article is part of the Research Topic World Diabetes Day 2024: Scalable Solutions for Improving Mental Well-being View all articles
Design and methods of a multicenter randomized clinical trial of effects of diabetes-educated psychologist on glucose management and diabetes distress
Provisionally accepted- 1 Department of Molecular and Clinical Medicine, Sahlgrenska Academy,, University of Gothenburg, Gothenburg, Sweden
- 2 Department of Psychology, Stockholm University, Stockholm, Stockholm, Sweden
- 3 Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- 4 Department of Medicine, NU Hospital Group., Uddevalla, Trollhättan, Sweden
- 5 Department of Internal Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Introduction: Many people with type 1 diabetes struggle to manage their glucose levels and experience stress related to the behavioral demands of the disease. The aim of this study is to investigate whether treatment with a diabetes-educated psychologist can improve glucose levels and decrease diabetes distress. Materials and methods: Individuals with HbA1c >62 mmol/mol (7.8%) were randomized to either psychological treatment or control group. The study duration for each participant was 52 weeks. Patients who received treatment met with a diabetes-educated psychologist a minimum of seven times. In total 6 outpatient diabetes units and 10 psychologists participated. Cognitive behavioral therapy was primarily the treatment of choice. Both groups met with a diabetes nurse and/or doctor at the start of the study and at 3, 6, and 12 months. HbA1c, blood pressure, and weight were measured at scheduled visits. Diabetes distress, quality of life, hypoglycemia confidence, and treatment satisfaction were evaluated using questionnaires. The primary endpoint is the difference in HbA1c from baseline to week 52. Secondary endpoints are changes in diabetes distress and quality of life from baseline to week 52, as well as treatment satisfaction at 52 weeks. Discussion: This study seeks to improve knowledge about how to support patients who struggle to manage their diabetes. If the results of this study show that psychological treatment has an effect on HbA1c or on diabetes-related stress, it could indicate that psychologists should become more involved in diabetes care teams. Clinical trial registration: ClinicalTrials.gov ID NCT03753997
Keywords: Type 1 diabetes (T1D), Diabetes distress, HbA1c - hemoglobin A1c, Diabetes-educated psychologist, Cognitive behavioural therapy (CBT)
Received: 20 Dec 2024; Accepted: 24 Mar 2025.
Copyright: © 2025 Zeijlemaker, Anderbro, Sterner Isaksson and Lind. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Marcus Lind, Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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