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Type 1 diabetes is associated with a significant increase in mortality, cardiovascular disease, injuries on eyes and kidneys. These risks are largely dependent on glycemic control. Multiple strategies of achieving good glycemic control exist. Despite this, only about 20 % of patients in Sweden reach the target HbA1c of ≤ 52 mmol/mol.
It is well-known that when the motivation is high, a large proportion of patients reach good glycaemic control with current treatments, e.g. most pregnant women reach a much better glycaemic control. The patient is then motivated to a greater extent in managing the disease, e.g. by carefully dosing insulin and more closely monitoring blood glucose levels.
Moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers in being compliant with treatments such as depression, eating disorders and attention deficit disorders (ADHD). Further, identified specific diabetes-related psychosocial factors include severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor relationship with physician, feelings of powerlessness and treatment skepticism. These parameters can be measured via a diabetes distress scale where a high score is correlated to higher HbA1c.
The majority of outpatient diabetes clinics in Sweden today request the resource of a diabetes-educated psychologist. However, more evidence is needed from randomized multicentre trials whether such a resource would help to improve HbA1c, reduce diabetes-related distress and improve quality of life.
The primary aim of the current study is to evaluate whether the assistance of a diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves HbA1c. Secondary endpoints include studying its influence on diabetes-related distress and quality of life. The study is a 1 year randomized trial where the intervention group will meet with a diabetes-educated psychologist in addition to conventional care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional therapy | No Intervention | Patiens´s will come to the clinic for regular contact with a diabetes nurse. | |
| Treatment by a Psychologist | Experimental | Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment by a diabetes educated psychologist | Behavioral | Patients will meet a diabetes educated psychologist. There will be a minimum of 5 meetings during the first 3 months and then in the following 6 months there will be a minimum of 2 meetings. More meetings will be scheduled if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline to 52 weeks follow-up | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes distress scale score from baseline to week 52 | Diabetes Distress scale is a questionnaire with 28 questions where patients answer on a scale between 1-6. | 52 weeks |
| Change in quality of life score (ADDQoL) from baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52 | 8 questions which patients answer on a scale of 6 to 0 | 52 weeks |
| Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Lind, PhD | NU-Hospital Organization, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NU Hospital Group | Uddevalla | 45180 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40308292 | Derived | Zeijlemaker J, Anderbro T, Sterner Isaksson S, Lind M. Design and methods of a multicenter randomized clinical trial of effects of diabetes-educated psychologist on glucose management and diabetes distress. Front Clin Diabetes Healthc. 2025 Apr 16;6:1549234. doi: 10.3389/fcdhc.2025.1549234. eCollection 2025. |
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|
ADDQoL (actual name for questionnaire) is a quality of life questionnaire with 19 questions. Answers are on a scale of 1-4,1-5,1-6 and 1-7
| 52 weeks |
| score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52 | 8 questions which patients answer on a scale of -3 to 3 | 52 weeks |
9 questions with 4 answer possibilities. Not confident at all, to very confident |
| 52 weeks |
| Proportion of patients with HbA1c less than 59 mmol/mol at week 52 | 52 weeks |
| Proportion of patients with HbA1c less than 53 mmol/mol at week 52 | 52 weeks |
| Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52 | 52 weeks |
| Change in total insulin dose from baseline to week 52 | 52 weeks |
| change weight from baseline to week 52 | 52 weeks |
| Change in systolic and diastolic blood pressure from baseline to week 52 | Change in systolic and diastolic blood pressure. | 52 week |