Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT01069393
Status:
COMPLETED
Last Update Posted:
2014-11-19
First Post:
2010-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2010-02-10', 'studyFirstSubmitQcDate': '2010-02-15', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in HbA1c (glycosylated haemoglobin)', 'timeFrame': '6 & 12 months'}], 'secondaryOutcomes': [{'measure': 'Number of severe hypoglycaemic episodes', 'timeFrame': '12 months'}, {'measure': 'Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires', 'timeFrame': '12 months'}, {'measure': "Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention", 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23136929', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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\n\nApproximately 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults with Type 1 diabetes for at least 6 months\n* HbA1c \\<12%\n* willing to undertake intensive insulin therapy\n\nExclusion Criteria:\n\n* severe diabetic complications (making group education difficult)\n* inability to communicate in English\n* strong preference for on attending a one week course or one day a week for 5 consecutive weeks\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01069393', 'briefTitle': 'Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT', 'orgStudyIdInfo': {'id': 'STH15581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard DAFNE', 'description': 'Usual DAFNE course taught over 5 consecutive days in one week', 'interventionNames': ['Other: DAFNE course (Timing of delivery of education)']}, {'type': 'EXPERIMENTAL', 'label': 'DAFNE 5x1 day', 'description': 'DAFNE course taught 1 day a week for 5 consecutive weeks', 'interventionNames': ['Other: DAFNE course (Timing of delivery of education)']}], 'interventions': [{'name': 'DAFNE course (Timing of delivery of education)', 'type': 'OTHER', 'description': 'Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.', 'armGroupLabels': ['DAFNE 5x1 day', 'Standard DAFNE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow & Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Lancashire', 'country': 'United Kingdom', 'facility': 'East Lancashire Hospitals NHS Trust'}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals, Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust'}, {'city': 'Northumbria', 'country': 'United Kingdom', 'facility': 'Northumbria Healthcare NHS Foundation Trust'}], 'overallOfficials': [{'name': 'Simon Heller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University College London Hospitals', 'class': 'OTHER'}, {'name': 'Northumbria Healthcare NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, {'name': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'East Lancashire Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}