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

Abstract

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.

Effects of nutrition education using a food-based approach, carbohydrate counting or routine care in type 1 diabetes: 12 months prospective randomized trial

“…This is supported by another study with the same approach as DAFNE, but with subjects with moderate glycemic control that also failed to see any effects on HbA1c. 23 Another aspect is that FBA and RC received more active comparison treatment compared with the control group in DAFNE. In DAFNE, they also had positive results in 'present quality of life' and 'freedom to eat'.…”

2021 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association

“…The recommended glycemic target for patients with type 1 diabetes mellitus (T1DM) is an A1C <7.0% (RCT, General). All patients with T1DM should be systematically trained to adjust their insulin dose so that they can have flexible meals (RCT, General) [51][52][53][54]. The level of understanding following education and performance among patients with T1DM should be evaluated, and patients should receive regular feedback following a diagnosis of diabetes (Expert opinion, General).…”

The Effects of Diabetes Self-Management Education on Quality of Life for Persons With Type 1 Diabetes: A Systematic Review of Randomized Controlled Trials

“…One study reported that 20.6% of participants incorporated continuous glucose monitoring (CGM) into diabetes self-management practices. 63 Participant comorbidities, which included retinopathy (n = 2), 44,61,67 neuropathy (n = 2), 44,61,67 chronic kidney disease, 61,67 hypertension (n = 1), 67 dyslipidemia (n = 2), 67,68 overweight/obesity (n = 1), 63 and depression (n = 2), 44,61,67 were reported in only 4 studies (5 reports).…”

“…63,68 One study did not clearly define the duration. 60 The frequency of encounters varied from daily in course-based education, 56,57,67 multiple times per week, 53 weekly, 62,66 multiple times per month, 44,61 monthly, 54,55,60,65 and every 3 to 4 months. 68 Other interventions utilized only 1 encounter, 64 individualized frequencies, 58 decreasing frequencies of participant contact over the intervention period, 59 or intervals with unspecified frequencies.…”