DIABETES-PRO study V1.0.3
Research type
Research Study
Full title
A feasibility study evaluating the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient reported outcome measures.
IRAS ID
337691
Contact name
John Wilding
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Type 2 diabetes accounts for 90% of all diabetes diagnoses. Without proper care, type 2 diabetes can result in complications such as stroke, heart disease, kidney disease, eye disease and nerve damage. On average, a person with diabetes spends less than three hours a year with a healthcare professional meaning patients must manage their own diabetes almost 100% of the time. Diabetes self-management education plays an important role in helping people stay healthy, live well, and avoid life threatening complications and is proven to be effective in lowering blood glucose levels and preventing health problems later in life. Despite an increased awareness of the importance of education for people with type 2 diabetes, attendance at education programmes remains very poor with little to no change over the past decade.
Many things can prevent attendance or completion of education programmes, including physical and mental health issues, reduced finances, work and childcare commitments, location of education programmes and lack of information on programme content or availability. Little is known on the effectiveness of only attending part of an education programme on a person’s ability to self-care.
This study will examine the impact of differing completion rates of diabetes self-management education programmes on a person’s self-care skills. Participants will be randomised to one of 4 groups (100%; 60%; 10%; 0% education completion) which will have differing levels of education completion. Participants will be asked to complete 3 validated patient reported outcome measures before and up to 4 months after education.
The psychological impact of not completing a diabetes self-management education programme is unknown and a better understanding of this could help tailor future education offers for people with type 2 diabetes. This is a smaller study (a feasibility study) to see if a larger project is feasible in the future.
Lay summary of study results: This study looked at how attending different amounts of a diabetes self-management education (DSME) course affects people’s ability to manage their diabetes, their emotional health, and overall quality of life.
Diabetes self-management education is a recommended program designed to help people with type 2 diabetes manage their condition and avoid long-term health problems. Usually, people are considered to have “completed” the program if they attend 100% of the course. However, nationally, a person is recorded as having completed the program if they attend at least 60%, and considered to have ‘attended’ if they take part in at least 10%. It is unclear how much benefit people get if they attend less than the full program.
This study tested how different amounts of DSME attendance—ranging from no attendance, to 10%, 60%, and 100% of the course—affect people’s ability to manage their diabetes and their well-being.
We invited 138 adults with type 2 diabetes from Northwest England to take part. We randomly assigned 120 adults to one of four groups based on how much of the course they would attend: none (0%), a little (10%), most (60%), or all (100%) of the course.
What did we find?
After 3-4 months, we found:People who completed 60% or more of the program showed significant improvements in managing their diabetes.
Those who completed the full course (100%) also had meaningful improvements in mental health and reduced diabetes-related distress.
Attending only 10% of the course did not provide any noticeable benefits compared to not attending at all.
People who didn’t attend any sessions experienced a decline in their diabetes self-care and quality of life.
What does this mean?
Completing at least 60% of a DSME course can significantly improve a person’s self-management skills, supporting the current benchmark of 60% completion. However, only full completion (100%) was linked to meaningful improvements in diabetes distress and mental health-related quality of life. This suggests that while 60% attendance is effective for improving self-care behaviours, completing the full program may be needed to achieve broader psychological and quality of life benefits.There is no evidence that minimal attendance (10%) at DSME programs has any meaningful impact on diabetes self-care skills, emotional health, or quality of life.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrials.gov%252Fstudy%252FNCT06419907%253Fterm%253Ddiabetes%2526lastUpdPost%253D2020-04-02_%2526viewType%253DTable%2526rank%253D10%2FNBTI%2FkL_-AQ%2FAQ%2F1347db59-5b28-4fd4-95e0-8c7d92da1cf9%2F1%2F0YHGW4Bcw9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C85348f0d7c8342c5c2f308dde95385d0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638923267187556950%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=vknMa4TjUjd4jw3qOB5EfwvntKeJE5OsapbSHKpCnzg%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 02/03/2026
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: As per dissemination plan all study participants were sent a letter thanking them for their support with the study and providing a summary of results.Ref: DIABETES-PRO research study
We wanted to say a heartfelt thank you to everyone who took part in our research study. Your time and effort have helped us better understand how diabetes education can improve health, well-being and make a real difference for people living with type 2 diabetes.
What was the study about?
This study looked at how attending different amounts of a diabetes self-management education course affects people’s ability to manage their diabetes, their emotional health, and quality of life.
Diabetes self-management education is a recommended program to help people with type 2 diabetes manage their condition and avoid long-term health problems. Usually, people would consider they have “completed” a program if they attend 100% of the course. However nationally a person would be recorded as having completed where they complete at least 60%, and ‘attended’ when they take part in minimal amounts (10%). But it’s unclear how much benefit people get if they attend less than the full programme.
This study tested how different amounts of attendance—ranging from no attendance, to 10%, 60%, and 100% of the course—affect people’s ability to manage their diabetes and well-being.
We invited 138 adults with type 2 diabetes from Northwest England to join. We randomly split 120 adults to one of the four groups.
What did we find?
After 3-4 months, we found:
• People who completed 60% or more of the program showed significant improvements in managing their diabetes.
• Those who completed the full course (100%) also had meaningful improvements in mental health and reduced diabetes-related distress.
• Attending only 10% of the course did not provide any noticeable benefits compared to not attending at all.
• People who didn’t attend any sessions experienced a decline in their diabetes self-care and quality of life.
What does this mean?
If you go to at least 60% of a diabetes self-management course, it helps you to take better care of your diabetes. However, it is best to complete the full course (100%) if you want to feel better emotionally and improve your quality of life. Attending a small amount of the course is unlikely to help.
Thank You Again
Your help made this research possible, and we’re so grateful for your support. This study has shown that more research can be done on a larger scale to help shape better diabetes care in the future.
If you would like to access our diabetes self-management course or if you have any questions or want to know more about the results, you can:
📧 Email: gemma.lewis@sthk.nhs.uk
📮 Write to us: Diabetes Centre, St Helens Hospital, Marshalls Cross Road, St Helens, WA9 3DAThank you for taking the time to read this letter.
Yours SincerelyGemma Lewis,
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Publications, posters, and abstracts are planned as part of the dissemination plan within suitable journals and professional national and international conferences. Following publication of the research the data will be owned by the study sponsor, University of Liverpool, and will be made available via the research data repository
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: N/A
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London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0235
Date of REC Opinion
22 Apr 2024
REC opinion
Further Information Favourable Opinion