Clinical trial NCT03699189: ANAIS, a Spanish Version of the DAFNE Programme
Official title: Assessment of ANAIS (Alimentación Normal Con Ajuste de InSulina), a Spanish Version of the DAFNE (Dose Adjustment for Normal Eating) Programme, in Patients With Type 1 Diabetes: a Randomised, Controlled, Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes
education programme
quality of life
dietary freedom
patient empowerment
Lead sponsor: Hospital Universitario Insular Gran Canaria
Sponsor class: OTHER
Collaborators: name: Ana M. Wägner
name: Dácil Alvarado-Martel
name: Yaiza López-Plasencia
name: Armando Carrillo-Domínguez
name: Julia Rodríguez-Cordero
name: Francisco J Nóvoa-Mogollón
name: Angelines Jiménez-Rodríguez
First posted: 2018-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, controlled, parallel trial.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Exclusion Criteria:

Exclusion criteria included severe psychiatric illness, pregnancy, or other circumstances that, according to the investigators' criteria, could interfere with study completion.

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Lipids
timeFrame: Baseline, 3, 6 and 12 month
measure: Weight
timeFrame: Baseline, 3, 6 and 12 month
measure: Hypoglycemic events
timeFrame: Baseline, 3, 6 and 12 month
measure: Treatment satisfaction
timeFrame: Baseline, 3, 6 and 12 month
measure: Self-defined objectives
timeFrame: Baseline, 3, 6 and 12 month
measure: The quality of life
timeFrame: Baseline, 3, 6 and 12 month
Other outcomes:
Locations:
Study officials:
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