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

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Type 1; Disease: Diabetic Control, Education; Nutritional, Metabolic, Endocrine; Type 1 diabetes

• Registration Number: ISRCTN04179596
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-21
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c %, measured at baseline and 6 months post-course

Secondary Outcome Measures

Name	Time	Method
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<br>2. Changes in weight, measured at baseline and 6 months<br>3. Diet related behaviours, measured at baseline and 6 months<br>4. Number and severity of hypoglycaemic episodes, measured at baseline, 6 weeks post-course and 6 months post-course