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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03753997
• Other study ID #: Psychologystudy
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: December 31, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Psychology Functional Behavior
• Type1diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	NU Hospital Group	Uddevalla

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the Diabetes Treatment satisfaction questionnaire - status (DTSQs) score from baseline to week 52	8 questions which patients answer on a scale of 6 to 0	52 weeks
Other	Change in the score of the hypoglycaemia confidence questionnaire from baseline to week 52	9 questions with 4 answer possibilities. Not confident at all, to very confident	52 weeks
Other	Proportion of patients with HbA1c less than 59 mmol/mol at week 52		52 weeks
Other	Proportion of patients with HbA1c less than 53 mmol/mol at week 52		52 weeks
Other	Proportion of patients lowering HbA1c 5 mmol/mol or more from baseline to week 52		52 weeks
Other	Change in total insulin dose from baseline to week 52		52 weeks
Other	change weight from baseline to week 52		52 weeks
Other	Change in systolic and diastolic blood pressure from baseline to week 52	Change in systolic and diastolic blood pressure.	52 week
Primary	Change in HbA1c from baseline to 52 weeks follow-up		52 weeks
Secondary	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
Secondary	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
Secondary	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