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

NCT ID: NCT03753997

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Type1diabetes; Psychology Functional Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Conventional therapy

Patiens´s will come to the clinic for regular contact with a diabetes nurse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment by a Psychologist

Patients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse

Group Type: EXPERIMENTAL

Treatment by a diabetes educated psychologist

Intervention Type: 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.

Interventions

Treatment by a diabetes educated psychologist

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Lind, PhD

Role: PRINCIPAL_INVESTIGATOR

NU-Hospital Organization, Sweden

Locations

NU Hospital Group

Uddevalla, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 40308292 (View on PubMed)

Other Identifiers

Psychologystudy

Identifier Type: -

Identifier Source: org_study_id