Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with type 1 diabetes for over one year 2. Attending the adult diabetes clinic in one of the participating centres 3. Ability to speak and read English 4. Willingness to monitor blood sugar levels at regular intervals 5. Willingness to transition to a basal/bolus insulin regimen prior to DAFNE training (if not already on such a regimen) 6. Glycosylated haemoglobin (HbA1c) level below 13 percent at recruitment Added as of 13/02/2009: 7. Both males and females, 18 years old or greater Please note that as of 30/07/07, the previous inclusion criteria point six read as: 6. Glycosylated haemoglobin (HbA1c) level between 7.5 and 13 percent at recruitment
Exclusion criteria
Exclusion criteria: 1. Patients with type 2 diabetes 2. Attending a paediatric clinic 3. Pregnant or planning a pregnancy in the next 2 years 4. Presence of advanced diabetic complications (e.g. kidney failure with serum creatinine >250 µmol/L) 5. Serious co-morbidity likely to interfere with study participation 6. Previous DAFNE training or current use of a continuous subcutaneous insulin infusion pump
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Longitudinal change in mean HbA1c level between baseline and follow-up. Added as of 17/02/2009: All primary and secondary outcomes will be assessed at 6, 12 and 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of severe hypoglycaemia 2. Change in weight and psychological measures of wellbeing and quality of life Added as of 17/02/2009: The following scales are used to assess psychological measures of wellbeing and quality of life: 1. Hospital Anxiety and Depression Scale (HADS) 2. Problem Areas in Diabetes (PAID) Questionnaire 3. Disease Specific Quality of Life questionnaire (DSQOL) 4. Euroqol EQ-5D 5. Sub-study: comparison of Audit of Diabetes-Dependent Quality of Life (ADDQOL) vs Diabetes Treatment Satisifaction Questionnaire (DTSQ) 6. Health Economics Questionnaire (developed for the study) All primary and secondary outcomes will be assessed at 6, 12 and 18 months. | — |
Countries
Ireland