Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03753997

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Type1diabetes Psychology Functional Behavior

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NU Hospital Group

Uddevalla, 45180, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in HbA1c from baseline to 52 weeks follow-up

    Time frame: 52 weeks

Secondary outcomes

  1. Change in Diabetes distress scale score from baseline to week 52

    Time frame: 52 weeks

    Diabetes Distress scale is a questionnaire with 28 questions where patients answer on a scale between 1-6.

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

    Time frame: 52 weeks

    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

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

    Time frame: 52 weeks

    8 questions which patients answer on a scale of -3 to 3

Other outcomes

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

    Time frame: 52 weeks

    8 questions which patients answer on a scale of 6 to 0

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

    Time frame: 52 weeks

    9 questions with 4 answer possibilities. Not confident at all, to very confident

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

    Time frame: 52 weeks

  4. Proportion of patients with HbA1c less than 53 mmol/mol at week 52

    Time frame: 52 weeks

  5. Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52

    Time frame: 52 weeks

  6. Change in total insulin dose from baseline to week 52

    Time frame: 52 weeks

  7. change weight from baseline to week 52

    Time frame: 52 weeks

  8. Change in systolic and diastolic blood pressure from baseline to week 52

    Time frame: 52 week

    Change in systolic and diastolic blood pressure.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Nov 27, 2018
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.