Trial Outcomes & Findings for Differing Completion Rates of DIABETES Education on Patient Reported Outcomes (NCT NCT06419907)
NCT ID: NCT06419907
Last Updated: 2025-09-22
Results Overview
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.
COMPLETED
NA
120 participants
3-4 months post baseline
2025-09-22
Participant Flow
120 participants consented and were randomised between May 2024 and February 2025 (30 per group). 68% of these were from secondary care clinics, 32% from primary care services (GP referrals and shared care reports).
Patients with a recorded clinical diagnosis of type 2 diabetes aged ≥18 years who met local and national eligibility criteria for DSME who could provide written informed consent and were responsible for daily management of their diabetes. Exclusion criteria include: * Lack capacity to make an informed decision. * Type 1, type 3c, monogenic or gestational diabetes. * Received structured education for diabetes within last 12 months either online or face to face. * Require 1:1 education
Participant milestones
| Measure |
Group 1
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
27
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group 1
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
Baseline characteristics by cohort
| Measure |
Group 1
n=30 Participants
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
n=27 Participants
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
n=28 Participants
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
n=28 Participants
Will not attend a face to face 6 hour structured diabetes self management education session
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 year
STANDARD_DEVIATION 13 • n=5 Participants
|
62 year
STANDARD_DEVIATION 12 • n=7 Participants
|
62 year
STANDARD_DEVIATION 17 • n=5 Participants
|
60 year
STANDARD_DEVIATION 16 • n=4 Participants
|
61 year
STANDARD_DEVIATION 14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Index of multiple deprivation (IMD)
|
3 units on a scale
STANDARD_DEVIATION 5 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION 4 • n=7 Participants
|
2 units on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION 4 • n=4 Participants
|
3 units on a scale
STANDARD_DEVIATION 4 • n=21 Participants
|
|
Charlson Comorbidity index
|
3 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=7 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
3 units on a scale
STANDARD_DEVIATION 4 • n=4 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=21 Participants
|
PRIMARY outcome
Timeframe: 3-4 months post baselinePopulation: 3 lost to follow up, 4 removed as not per protocol
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.
Outcome measures
| Measure |
Group 1
n=30 Participants
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
n=27 Participants
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
n=28 Participants
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
n=28 Participants
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention
|
.96 change score (difference in pre-post)
Standard Deviation 2.75
|
1.08 change score (difference in pre-post)
Standard Deviation 2.0
|
.28 change score (difference in pre-post)
Standard Deviation 1.24
|
-.17 change score (difference in pre-post)
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Measured at baseline and 3-4 months after interventionPopulation: Four participants were not included in the final analysis due to protocol deviations: three attended Insulin safe start\[29\] structured education during the trial to meet their medical needs, one of whom was of mixed ethnicity, and another completed 100% DSME instead of the randomised 60%. A further 3 were lost to follow up
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.
Outcome measures
| Measure |
Group 1
n=30 Participants
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
n=27 Participants
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
n=28 Participants
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
n=28 Participants
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool
|
8.14 adjusted change score -dif in pre & post
Standard Error 2.44
|
7.14 adjusted change score -dif in pre & post
Standard Error 2.53
|
2.54 adjusted change score -dif in pre & post
Standard Error 2.52
|
-6.5 adjusted change score -dif in pre & post
Standard Error 2.48
|
SECONDARY outcome
Timeframe: Measured at baseline and 3-4 months after interventionPopulation: Four participants were not included in the final analysis due to protocol deviations: three attended Insulin safe start\[29\] structured education during the trial to meet their medical needs, one of whom was of mixed ethnicity, and another completed 100% DSME instead of the randomised 60%. A further 3 were lost to follow up
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.
Outcome measures
| Measure |
Group 1
n=30 Participants
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
n=27 Participants
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
n=28 Participants
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
n=28 Participants
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
• Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
|
3.0 change score -dif in pre & post
Standard Deviation 6.18
|
1.07 change score -dif in pre & post
Standard Deviation 4.77
|
-.88 change score -dif in pre & post
Standard Deviation 7.67
|
-.61 change score -dif in pre & post
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: 3-4 months post baselinePopulation: 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.
Outcome measures
| Measure |
Group 1
n=30 Participants
100% of a face to face 6 hour structured diabetes self management education session
|
Group 2
n=27 Participants
60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes.
|
Group 3
n=28 Participants
10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes.
|
Group 4
n=28 Participants
Will not attend a face to face 6 hour structured diabetes self management education session
|
|---|---|---|---|---|
|
Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale
|
2.27 change score -dif in pre & post
Standard Deviation 6.95
|
2.58 change score -dif in pre & post
Standard Deviation 4.92
|
-.67 change score -dif in pre & post
Standard Deviation 6.56
|
.48 change score -dif in pre & post
Standard Deviation 7.15
|
Adverse Events
Group 1
Group 2
Group 3
Group 4
Serious adverse events
| Measure |
Group 1
n=30 participants at risk
3 participants had adverse events none study related - hospitalisation for exacerbations of existing health conditions.
|
Group 2
n=27 participants at risk
0 adverse events
|
Group 3
n=28 participants at risk
0 adverse events
|
Group 4
n=28 participants at risk
1 participant had adverse event none study related - hospitalisation for exacerbations of existing health conditions.
|
|---|---|---|---|---|
|
General disorders
None was deemed to be study related and all were exacerbations of existing health conditions.
|
10.0%
3/30 • Number of events 7 • from enrolment until end of follow-up, up to 20 weeks
all adverse events reported as per protocol
|
0.00%
0/27 • from enrolment until end of follow-up, up to 20 weeks
all adverse events reported as per protocol
|
0.00%
0/28 • from enrolment until end of follow-up, up to 20 weeks
all adverse events reported as per protocol
|
3.6%
1/28 • Number of events 1 • from enrolment until end of follow-up, up to 20 weeks
all adverse events reported as per protocol
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place