NCT01069393

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

February 10, 2010

Last Update Submit

November 18, 2014

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Improvement in HbA1c (glycosylated haemoglobin)

    6 & 12 months

Secondary Outcomes (3)

  • Number of severe hypoglycaemic episodes

    12 months

  • Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires

    12 months

  • Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention

    12 months

Study Arms (2)

Standard DAFNE

ACTIVE COMPARATOR

Usual DAFNE course taught over 5 consecutive days in one week

Other: DAFNE course (Timing of delivery of education)

DAFNE 5x1 day

EXPERIMENTAL

DAFNE course taught 1 day a week for 5 consecutive weeks

Other: DAFNE course (Timing of delivery of education)

Interventions

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.

DAFNE 5x1 dayStandard DAFNE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with Type 1 diabetes for at least 6 months
  • HbA1c \<12%
  • willing to undertake intensive insulin therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

East Lancashire Hospitals NHS Trust

Lancashire, United Kingdom

Location

University Hospitals, Leicester

Leicester, United Kingdom

Location

University College London

London, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norfolk, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Northumbria, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23136929DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Simon Heller, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 17, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

GB(7)