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

NCT03753997 | Active Not Recruiting DMC

• 1 other identifier: Psychologystudy
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline to 52 weeks follow-up

  52 weeks

Secondary Outcomes (3)

• Change in Diabetes distress scale score from baseline to week 52

  52 weeks

• Change in quality of life score (ADDQoL) from baseline to week 52

  52 weeks

• score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52

  52 weeks

Other Outcomes (8)

• Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52

  52 weeks

• Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52

  52 weeks

• Proportion of patients with HbA1c less than 59 mmol/mol at week 52

  52 weeks

Study Arms (2)

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

Behavioral: Treatment by a diabetes educated psychologist

Interventions

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.

Treatment by a Psychologist

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

NU Hospital Group

Uddevalla, 45180, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40308292 DERIVED

Study Officials

• Marcus Lind, PhD

  NU-Hospital Organization, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: January 1, 2019
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

SE (1)