Diabetes Mellitus, Type 2DIABETES-PRONCT06419907
Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
A study testing Type 2 Live Well (structured diabetes self management education programme) in people with Diabetes Mellitus, Type 2 and Patient Education as Topic, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Patient Education as Topic
- What is being tested?
- Type 2 Live Well (structured diabetes self management education programme)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2024to 20 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able to provide informed consent and are responsible for daily management of their diabetes will be screened for entry into the study
Who cannot join
- The following patients will be excluded entry into the study:
- Lack capacity to make an informed decision.
- A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes.
- Received structured education for their diabetes within the last 12 months either online or face to face.
- Require 1:1 education support e.g., requires interpreter.
- Patients unable to attend for structured classroom education e.g., housebound.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Centre, St Helens Hospital
St Helens, WA93DA
About this study
Official 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.
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. The main question it aims to answer is:
- What is the impact of differing completion rates of DSME programmes on ability to self-care (primary outcome), diabetes distress and health related quality of life in type 2 diabetes.
Read more
Researchers will compare participants across four study groups (Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education) to see if patients who attend minimal aspects (10%) of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 % completion rate is as effective as 100% completion.
Participants will:
- complete three validated patient reported outcome measures testing self care activities, diabetes distress and health related quality of life.
- Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to.
- repeat the same three patient reported outcome measures 2-4 months after intervention. For participants in group 4 this will be 3-4 months from baseline.
Read the detailed description
Structured diabetes self-management education (DSME) is internationally recommended for all people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications. DSME is proven to be as effective as pharmacotherapy in preventing diabetes associated morbidity and premature mortality but attendance at both a national and local level remains poor. Local records suggest that of those that start DSME (9%) only 12.6% complete the programme. Attendance at DSME is currently benchmarked as having completed a registration form and had at least one active engagement with a programmes content, with 'completion' measured against ≥60% completion despite landmark trials reporting outcomes based on the full completion of a programme. Little is known, of the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme.
This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes.
Using a quantitative approach, a single centre, randomised feasibility study will be conducted, aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support, education and advice. Participants will be randomised into one of four groups: Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education. Normal clinical care will continue. Preliminary outcomes (psychometric questionnaire scores measuring ability to self-care, diabetes distress and health related quality of life) will be evaluated at baseline and 3-4 months post-intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported.
Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes, there is minimal understanding of the benefits of partial DSME completion on a person's ability to self-care despite national consensus accepting 60% attendance as 'completed'. The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates
- Being tested
- Type 2 Live Well (structured diabetes self management education programme)
- Keywords
- health education, patient reported outcome measures, type 2 diabetes mellitus, patient education as topic
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 2 Live Well (structured diabetes self management education programme)Behavioural
Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 100% of a face to face 6 hour structured diabetes self management education session Receives: Behavioral: Type 2 Live Well (structured diabetes self management education programme) |
| Group 2 | Experimental | 60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes. Receives: Behavioral: Type 2 Live Well (structured diabetes self management education programme) |
| Group 3 | Experimental | 10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes. Receives: Behavioral: Type 2 Live Well (structured diabetes self management education programme) |
| Group 4 | Active comparator | Will not attend a face to face 6 hour structured diabetes self management education session Receives: Behavioral: Type 2 Live Well (structured diabetes self management education programme) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention
Diabetes self management questionnaire with good interrater reliability. Higher score indicates better self management. 20 item questionnaire, scale 0-10 with some items reversed scored. Total score added together and then divided by 60. Scores can range form 0-10. A higher score indicates better self management.
To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured: 3-4 months post baseline
Secondary outcomes (3)
Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool
Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). 20 item questionnaire, scale 0-100. Scores ≥40 indicate risk of emotional burnout.
To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured: Measured at baseline and 3-4 months after intervention
• Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Validated tool measuring health related quality of life. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
T-score <50 worse than average, >50 better than average.
To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured: Measured at baseline and 3-4 months after intervention
Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Validated tool measuring health related quality of life. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
T-score <50 worse than average, >50 better than average.
To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
Measured: 3-4 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start16 May 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- St Helens & Knowsley Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Gemma A Lewis, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419907
- Sponsor's protocol ID
- UoL001848
- Other IDs
- 337691
- Acronym
- DIABETES-PRO
- Status last verified
- Aug 2024
- First submitted
- 9 May 2024
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All metadata records for the qualitative data will be uploaded onto the University research data repository. All records will be anonymised and identified by study number only in order to maintain confidentiality.
Publications
Lewis GA, Hughes DM, Irving GJ, Wilding JP, Hardy KJ. Randomised Controlled Feasibility Trial of Face-To-Face Diabetes Self-Management Education Shows High Completion Rates Are Needed to Improve Patient-Reported Outcomes. Diabetes Obes Metab. 2026 Aug;28(8):6997-7005. doi: 10.1111/dom.70917. Epub 2026 May 27.
PubMed 42203730Lewis G, Irving G, Wilding J, Hardy K. Evaluating the impact of differing completion rates of a face-to-face DIABETES self-management education programme on Patient Reported Outcome measures (DIABETES PRO): A feasibility trial protocol. Diabet Med. 2024 Dec;41(12):e15430. doi: 10.1111/dme.15430. Epub 2024 Sep 5.
PubMed 39235931
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06419907
- Acronym / sponsor ID
- DIABETES-PRO / UoL001848
- Keywords
- health education, patient reported outcome measures, type 2 diabetes mellitus, patient education as topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- St Helens & Knowsley Teaching Hospitals NHS Trust
- Study start
- 16 May 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. The main question it aims to answer is:
- What is the impact of differing completion rates of DSME programmes on ability to self-care (primary outcome), diabetes distress and health related quality of life in type 2 diabetes.
Researchers will compare participants across four study groups (Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education) to see if patients who attend minimal aspects (10%) of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 % completion rate is as effective as 100% completion.
Participants will:
- complete three validated patient reported outcome measures testing self care activities, diabetes distress and health related quality of life.
- Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to.
- repeat the same three patient reported outcome measures 2-4 months after intervention. For participants in group 4 this will be 3-4 months from baseline.
Detailed description
Structured diabetes self-management education (DSME) is internationally recommended for all people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications. DSME is proven to be as effective as pharmacotherapy in preventing diabetes associated morbidity and premature mortality but attendance at both a national and local level remains poor. Local records suggest that of those that start DSME (9%) only 12.6% complete the programme. Attendance at DSME is currently benchmarked as having completed a registration form and had at least one active engagement with a programmes content, with 'completion' measured against ≥60% completion despite landmark trials reporting outcomes based on the full completion of a programme. Little is known, of the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme.
This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes.
Using a quantitative approach, a single centre, randomised feasibility study will be conducted, aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support, education and advice. Participants will be randomised into one of four groups: Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education. Normal clinical care will continue. Preliminary outcomes (psychometric questionnaire scores measuring ability to self-care, diabetes distress and health related quality of life) will be evaluated at baseline and 3-4 months post-intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported.
Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes, there is minimal understanding of the benefits of partial DSME completion on a person's ability to self-care despite national consensus accepting 60% attendance as 'completed'. The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Type 2 Live Well (structured diabetes self management education programme)100% of a face to face 6 hour structured diabetes self management education session |
| Group 2 | Experimental | Behavioral: Type 2 Live Well (structured diabetes self management education programme)60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes. |
| Group 3 | Experimental | Behavioral: Type 2 Live Well (structured diabetes self management education programme)10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes. |
| Group 4 | Active comparator | Behavioral: Type 2 Live Well (structured diabetes self management education programme)Will not attend a face to face 6 hour structured diabetes self management education session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able to provide informed consent and are responsible for daily management of their diabetes will be screened for entry into the study
Key exclusion criteria (6 listed)
- Lack capacity to make an informed decision.
- A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes.
- Received structured education for their diabetes within the last 12 months either online or face to face.
- Require 1:1 education support e.g., requires interpreter.
- Patients unable to attend for structured classroom education e.g., housebound.
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 |
|---|---|---|
| Type 2 Live Well (structured diabetes self management education programme)Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention
Time frame: 3-4 months post baseline
Diabetes self management questionnaire with good interrater reliability. Higher score indicates better self management. 20 item questionnaire, scale 0-10 with some items reversed scored. Total score added together and then divided by 60. Scores can range form 0-10. A higher score indicates better self management. To calculate the change between baseline and follow up (4 months) we calculated the value at follow up minus baseline score.
3 secondary outcomes
Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool
Time frame: Measured at baseline and 3-4 months after intervention
• Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Time frame: Measured at baseline and 3-4 months after intervention
Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
Time frame: 3-4 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42203730Lewis GA, Hughes DM, Irving GJ, Wilding JP, Hardy KJ. Randomised Controlled Feasibility Trial of Face-To-Face Diabetes Self-Management Education Shows High Completion Rates Are Needed to Improve Patient-Reported Outcomes. Diabetes Obes Metab. 2026 Aug;28(8):6997-7005. doi: 10.1111/dom.70917. Epub 2026 May 27.
- Derived from this study: PubMed 39235931Lewis G, Irving G, Wilding J, Hardy K. Evaluating the impact of differing completion rates of a face-to-face DIABETES self-management education programme on Patient Reported Outcome measures (DIABETES PRO): A feasibility trial protocol. Diabet Med. 2024 Dec;41(12):e15430. doi: 10.1111/dme.15430. Epub 2024 Sep 5.
- Secure online environment for University of Liverpool Researchers to deposit, share and promote data and informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All metadata records for the qualitative data will be uploaded onto the University research data repository. All records will be anonymised and identified by study number only in order to maintain confidentiality.
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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.
Gemma A Lewis principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 2 Live Well (structured diabetes self management education programme) in people with Diabetes Mellitus, Type 2 and Patient Education as Topic, run by University of Liverpool at 1 site in United Kingdom.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention (time frame: 3-4 months post baseline). 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 NCT06419907, which also lists 2 linked publications.
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 22 Sep 2025.