Diabetes Mellitus, Type 1
Conditions
Keywords
type 1 diabetes, education programme, quality of life, dietary freedom, patient empowerment
Brief summary
ANAIS is a therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. Participants are randomised in two groups, to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS). The main outcome was HbA1c at one year.
Detailed description
ANAIS (Alimentación Normal con Ajuste de InSulina) is a Spanish version of the DAFNE programme, performed in patients with type 1 diabetes. ANAIS is a randomised, controlled, parallel trial. ANAIS is a group-based, therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. Participants with type 1 diabetes and an HbA1c between 7 and 10% were recruited from the outpatient clinics in a tertiary care center. They were randomised (opaque, sealed envelopes, 2:1 ratio) to attend the training course immediately (immediate ANAIS) or a year later (delayed ANAIS). The main outcome was HbA1c at one year. Secondary outcomes included lipids, weight, hypoglycemic events, treatment satisfaction, quality of life and self-defined objectives.
Interventions
BEHAVIORALImmediate ANAIS
ANAIS is a structured therapeutic education programme aimed at providing the patients with the necessary skills to manage their diabetes independently and confidently. The programme particularly promotes dietary freedom, in an intensive insulin regime, by enabling effective carbohydrate counting and accurate prandial insulin dose adjustment and avoiding hypoglycaemia. ANAIS was organised as a five day (Monday to Friday), seven-hour, outpatient programme using principles of adult education, with explicit learning objectives, in a group setting.
Sponsors
Ana M. Wägner
Dácil Alvarado-Martel
Yaiza López-Plasencia
Armando Carrillo-Domínguez
Julia Rodríguez-Cordero
Francisco J Nóvoa-Mogollón
Angelines Jiménez-Rodríguez
Rosa María Sánchez Hernández
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A randomised, controlled, parallel trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We considered patients to be eligible if they were aged over 18 years, had type 1 diabetes, had an HbA1c between 7-12%, (or HbA1c \< 7% with a history of severe hypoglycemia), duration of diabetes of more than two years without advanced complications and ability to understand written and spoken Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 1 year | Glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipids | Baseline, 3, 6 and 12 month | Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl) |
| Weight | Baseline, 3, 6 and 12 month | weight |
| Hypoglycemic events | Baseline, 3, 6 and 12 month | Number of hypoglycemic events |
| Treatment satisfaction | Baseline, 3, 6 and 12 month | Degree of treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Minimum score 0 points, maximum score 36 points. Higher values represent a better outcome. |
| Self-defined objectives | Baseline, 3, 6 and 12 month | Participants were asked to establish a maximum of 3 personal goals they wanted to achieve related to taking part in the programme |
| The quality of life | Baseline, 3, 6 and 12 month | Degree of quality of life measured by Spanish version of Jacobson's Diabetes Quality of Life questionnaire (EsDQoL). Minimum score 43 points, maximum score 210 points. Higher values represent a worse outcome. |
Outcome results
None listed