Type 1 Diabetes MellitusNCT01069393
Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
A study testing DAFNE course (Timing of delivery of education) in people with Type 1 Diabetes Mellitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 7 sites in United Kingdom.
Trial summary
The best format for the delivery of structured education for adults with Type 1 diabetes is unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a week for 3 to 5 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DAFNE course (Timing of delivery of education)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- adults with Type 1 diabetes for at least 6 months
- HbA1c <12%
- willing to undertake intensive insulin therapy
Who cannot join
- severe diabetic complications (making group education difficult)
- inability to communicate in English
- strong preference for on attending a one week course or one day a week for 5 consecutive weeks
- inability to give informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
NHS Greater Glasgow & Clyde
Glasgow
East Lancashire Hospitals NHS Trust
Lancashire
University Hospitals, Leicester
Leicester
University College London
London
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norfolk
Northumbria Healthcare NHS Foundation Trust
Northumbria
About this study
Official title: Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT
The best format for the delivery of structured education for adults with Type 1 diabetes is unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility.
Read the detailed description
The DAFNE (Dose Adjustment for Normal Eating) course is a 1-week structured education course teaching skills in insulin use and dietary freedom to individuals with Type 1 diabetes. At the moment, we do not understand enough about why some people get more out of the DAFNE programmes than others. Currently DAFNE is always taught over 1 week. We aim to find out whether or not the benefit of DAFNE is the same whether it is delivered over 5 consecutive days, or one day a week for 5 consecutive weeks. If the benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility. At present there have been no RCTs to address
Approximately 170 people will take part in this study over the next 2 years. Half the people who participate will be allocated to attend a DAFNE course over 5 consecutive days, and the other halfwill attend one day a week for 5 consecutive weeks. We will perform routine biomedical assessments as part of the DAFNE programme and normal diabetes care (e.g. HbA1c (a measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and ask patients to recall hypoglycaemic (low blood sugar) events. We will also ask participants to fill in some research questionnaires, they will take 45-60 minutes to fill in each time. They will include questions about their diabetes, quality of life, well-being and diabetes knowledge. These assessments will be made at 3 time points; baseline, 6 and 12 months.
The main outcome measure is change in HbA1c, with the other biomedical and psychosocial parameters being of secondary importance. These evaluations will help us develop the DAFNE programme further and inform us how best to deliver the course in the future.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DAFNE course (Timing of delivery of education)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAFNE course (Timing of delivery of education)Other
Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Standard DAFNE | Active comparator | Usual DAFNE course taught over 5 consecutive days in one week Receives: Other: DAFNE course (Timing of delivery of education) |
| DAFNE 5x1 day | Experimental | DAFNE course taught 1 day a week for 5 consecutive weeks Receives: Other: DAFNE course (Timing of delivery of education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in HbA1c (glycosylated haemoglobin)
Measured: 6 & 12 months
Secondary outcomes (3)
Number of severe hypoglycaemic episodes
Measured: 12 months
Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires
Measured: 12 months
Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
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 Type 1 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, Cambridge University Hospitals NHS Foundation Trust, University College London Hospitals, Northumbria Healthcare NHS Foundation Trust, NHS Greater Glasgow and Clyde, Norfolk and Norwich University Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Simon Heller, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069393
- Sponsor's protocol ID
- STH15581
- Status last verified
- Nov 2014
- First submitted
- 10 Feb 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Elliott J, Lawton J, Rankin D, Emery C, Campbell M, Dixon S, Heller S; NIHR DAFNE Research Study Group. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks. BMC Endocr Disord. 2012 Nov 8;12:28. doi: 10.1186/1472-6823-12-28.
PubMed 23136929
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT
- ClinicalTrials.gov ID
- NCT01069393
- Acronym / sponsor ID
- STH15581
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, Cambridge University Hospitals NHS Foundation Trust, University College London Hospitals, Northumbria Healthcare NHS Foundation Trust, NHS Greater Glasgow and Clyde, Norfolk and Norwich University Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- 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.
The best format for the delivery of structured education for adults with Type 1 diabetes is unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility.
Detailed description
The DAFNE (Dose Adjustment for Normal Eating) course is a 1-week structured education course teaching skills in insulin use and dietary freedom to individuals with Type 1 diabetes. At the moment, we do not understand enough about why some people get more out of the DAFNE programmes than others. Currently DAFNE is always taught over 1 week. We aim to find out whether or not the benefit of DAFNE is the same whether it is delivered over 5 consecutive days, or one day a week for 5 consecutive weeks. If the benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility. At present there have been no RCTs to address
Approximately 170 people will take part in this study over the next 2 years. Half the people who participate will be allocated to attend a DAFNE course over 5 consecutive days, and the other halfwill attend one day a week for 5 consecutive weeks. We will perform routine biomedical assessments as part of the DAFNE programme and normal diabetes care (e.g. HbA1c (a measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and ask patients to recall hypoglycaemic (low blood sugar) events. We will also ask participants to fill in some research questionnaires, they will take 45-60 minutes to fill in each time. They will include questions about their diabetes, quality of life, well-being and diabetes knowledge. These assessments will be made at 3 time points; baseline, 6 and 12 months.
The main outcome measure is change in HbA1c, with the other biomedical and psychosocial parameters being of secondary importance. These evaluations will help us develop the DAFNE programme further and inform us how best to deliver the course in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard DAFNE | Active comparator | Other: DAFNE course (Timing of delivery of education)Usual DAFNE course taught over 5 consecutive days in one week |
| DAFNE 5x1 day | Experimental | Other: DAFNE course (Timing of delivery of education)DAFNE course taught 1 day a week for 5 consecutive weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with Type 1 diabetes for at least 6 months
- HbA1c <12%
- willing to undertake intensive insulin therapy
Key exclusion criteria (4 listed)
- severe diabetic complications (making group education difficult)
- inability to communicate in English
- strong preference for on attending a one week course or one day a week for 5 consecutive weeks
- inability to give informed consent
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 |
|---|---|---|
| DAFNE course (Timing of delivery of education)Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week. | Other | DAFNE 5x1 day, Standard DAFNE |
Primary outcome
Improvement in HbA1c (glycosylated haemoglobin)
Time frame: 6 & 12 months
3 secondary outcomes
Number of severe hypoglycaemic episodes
Time frame: 12 months
Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires
Time frame: 12 months
Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Derived from this study: PubMed 23136929Elliott J, Lawton J, Rankin D, Emery C, Campbell M, Dixon S, Heller S; NIHR DAFNE Research Study Group. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks. BMC Endocr Disord. 2012 Nov 8;12:28. doi: 10.1186/1472-6823-12-28.
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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.
Simon Heller, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAFNE course (Timing of delivery of education) in people with Type 1 Diabetes Mellitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 7 sites 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 3 inclusion and 4 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in HbA1c (glycosylated haemoglobin) (time frame: 6 & 12 months). 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 NCT01069393, 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 19 Nov 2014.