A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress

Conditions
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Type1diabetes, Psychology Functional Behavior

Intervention / Treatment
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* Behavioral: Treatment by a diabetes educated psychologist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management) Clinical diagnosis of Type 1 diabetes Adult patients over 18 years of age HbA1c > 62 mmol/mol Exclusion Criteria: Type 2 diabetes Diabetes duration <1 year Long-term Systemic glucocorticoid treatment during the last 3 months Changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy Current or planned pregnancy or breastfeeding during the next 12 months Planned move during the next 12 months making it not possible to participate in study activities Other reason determined by the investigator not being appropriate for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional therapy<br>Patiens´s will come to the clinic for regular contact with a diabetes nurse. | |
| Experimental: Treatment by a Psychologist<br>Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse | Behavioral: Treatment by a diabetes educated psychologist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to 52 weeks follow-up |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |