Assessment of Alimentación Normal con Ajuste de Insulina (ANAIS), a Spanish version of the DAFNE programme, in people with Type 1 diabetes: a randomized controlled parallel trial

• Published in: Diabetic medicine Vol. 36; no. 8; pp. 1037 - 1045
• Main Authors: Sánchez‐Hernández, R. M., Alvarado‐Martel, D., López‐Plasencia, Y., Carrillo‐Domínguez, A., Jiménez‐Rodríguez, A., Rodríguez‐Cordero, J., Vera-Elzo, T., Santana del Pino, Á., Nóvoa‐Mogollón, F. J., Wägner, A. M.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-08-2019
• Subjects: Adult; Body Weight - physiology; Clinical Protocols; Diabetes; Diabetes mellitus; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - therapy; Energy Intake; Evidence-based medicine; Female; Food intake; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - therapeutic use; Male; Objectives; Patient Education as Topic - methods; Psychotherapy - methods; Quality of life; Treatment Outcome
• ISSN: 0742-3071; 1464-5491
• DOI: 10.1111/dme.13984

Aim
To evaluate the effects of Alimentación Normal con Ajuste de Insulina (ANAIS), a group‐based, therapeutic education programme for Type 1 diabetes based on a flexible insulin regimen adjusted to the individual's food intake.
Methods
Participants with Type 1 diabetes and HbA1c levels of 53–86 mmol/mol (7–10%) were recruited from outpatient clinics at a tertiary care centre. They were randomized (using opaque, sealed envelopes, with a 2:1 treatment allocation ratio) to attend the training course immediately (immediate ANAIS; intervention group) or a year later (delayed ANAIS; control group). The main outcome was HbA1c level at 1 year. Secondary outcomes included lipid levels, weight, hypoglycaemic events, insulin dose, treatment satisfaction, self‐perceived dietary freedom, quality of life and participant‐defined goals.
Results
A total of 48 participants were assigned to the intervention group and 32 to the control group. Twelve months after completing the training, adjusted HbA1c was not significantly different in the intervention group [64 ± 1.3 vs 68 ± 1.6 mmol/mol (8.0 ±0.1% vs 8.4 ±0.1%); P=0.081]. Treatment satisfaction was significantly higher in the intervention group, but no differences were found in hypoglycaemic events, weight, insulin dose or changes in dietary freedom. At 1 year after the intervention, 72% of the participants (vs 33% in the control group; P=0.046) reported exceeding their expectations regarding achievement of their main personal goal.
Conclusion
Promoting dietary freedom and empowering people with Type 1 diabetes through structured education programmes, such as ANAIS, improves treatment satisfaction and self‐defined goals. No significant improvement in HbA1c level was achieved.
What's new?
The Dose Adjustment for Normal Eating (DAFNE) programme has previously been shown to improve glycaemic control and quality of life in people with Type 1 diabetes.
Alimentación Normal con Ajuste de Insulina (ANAIS), a Spanish adaptation of DAFNE, was assessed in a randomized controlled trial, which showed an improvement in treatment satisfaction and in personal goal achievement.
ANAIS should be implemented in the routine care of people with Type 1 diabetes in Spain.