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

Vastra Gotaland Region

Status

Active, not recruiting

Conditions

Psychology Functional Behavior

Type1diabetes

Treatments

Behavioral: Treatment by a diabetes educated psychologist

Study type

Interventional

Funder types

Other

Identifiers

NCT03753997

Psychologystudy

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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