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Implementing and evaluating a structured education programme and a new model of ongoing care for type 1 diabetes: the Irish Dose Adjustment For Normal Eating (DAFNE) study

Implementing and evaluating a structured education programme and a new model of ongoing care for type 1 diabetes: the Irish Dose Adjustment For Normal Eating (DAFNE) study - a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79759174
Enrollment
438
Registered
2007-02-09
Start date
2007-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

After obtaining informed consent participants will be assigned to the next available DAFNE course in their participating centre. Prior to commencement of the course, baseline data will be collected. I

Sponsors

Health Research Board (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026