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Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes incorporating insulin infusion pump start

Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes delivering the skills to undertake both DAFNE insulin adjustment and continuous subcutaneous insulin infusion: pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04179596
Enrollment
64
Registered
2010-05-21
Start date
2009-09-16
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Diabetes Research Network

Interventions

Intervention: a DAFNE educational course, 5 day, outpatient, skills training course, incorporating the additional training necessary to teach participants to use an insulin infusion pump (CSII) as the

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. T1DM of at least 1 year's duration 2. Waiting to attend a standard DAFNE skills 5 day course 3. Aged 18 - 80 years, either sex 4. Not been treated by continuous subcutaneous insulin infusion pump for the last four years

Exclusion criteria

Exclusion criteria: 1. Factors which will impair participation in group education, i.e., non-English speaking 2. Evidence of an eating disorder 3. Previous significant experience of pump therapy (greater than 6 months in the last 4 years)

Design outcomes

Primary

MeasureTime frame
Change in HbA1c %, measured at baseline and 6 months post-course

Secondary

MeasureTime frame
1. Change in psychological outcome, specifically reduction in anxiety and depression scores on Hospital Anxiety and Depression Scale (HADS), measured at baseline and 6 months 2. Changes in weight, measured at baseline and 6 months 3. Diet related behaviours, measured at baseline and 6 months 4. Number and severity of hypoglycaemic episodes, measured at baseline, 6 weeks post-course and 6 months post-course

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026