Type1diabetesNCT03753997
A Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress
A study testing Treatment by a diabetes educated psychologist in people with Type1diabetes and Psychology Functional Behavior, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type1diabetes, Psychology Functional Behavior
- What is being tested?
- Treatment by a diabetes educated psychologist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized 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.
Read more
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
- Being tested
- Treatment by a diabetes educated psychologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment by a diabetes educated psychologistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Treatment by a diabetes educated psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to 52 weeks follow-up
Measured: 52 weeks
Secondary outcomes (3)
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.
Measured: 52 weeks
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
Measured: 52 weeks
score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52
8 questions which patients answer on a scale of -3 to 3
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jan 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marcus Lind, PhD, Principal investigator, NU-Hospital Organization, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753997
- Sponsor's protocol ID
- Psychologystudy
- Status last verified
- May 2024
- First submitted
- 21 Nov 2018
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40308292
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Diabetes-educated Psychologist to Improve HbA1c and Reduce Diabetes-related Distress
- ClinicalTrials.gov ID
- NCT03753997
- Acronym / sponsor ID
- Psychologystudy
- Conditions
- Type1diabetes, Psychology Functional Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | No intervention | –Patiens´s will come to the clinic for regular contact with a diabetes nurse. |
| Treatment by a Psychologist | Experimental | Behavioral: Treatment by a diabetes educated psychologistPatients will meet with a diabetes educated psychologist over 9 months and will come to the clinic for regular contact with a diabetes nurse |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment by a diabetes educated psychologistPatients 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. | Behavioural | Treatment by a Psychologist |
Primary outcome
Change in HbA1c from baseline to 52 weeks follow-up
Time frame: 52 weeks
3 secondary outcomes
Change in Diabetes distress scale score from baseline to week 52
Time frame: 52 weeks
Change in quality of life score (ADDQoL) from baseline to week 52
Time frame: 52 weeks
score of Diabetes Treatment satisfaction questionnaire - change (DTSQc) at week 52
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 40308292Zeijlemaker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Lind, PhD principal investigator
NU-Hospital Organization, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment by a diabetes educated psychologist in people with Type1diabetes and Psychology Functional Behavior, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline to 52 weeks follow-up (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.