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Completed

NCT Number: NCT03699189

ANAIS, a Spanish Version of the DAFNE Programme

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate ANAIS

Behavioral

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.

Primary outcomes

  1. HbA1c

    Time frame: 1 year

    Glycated hemoglobin

Secondary outcomes

  1. Lipids

    Time frame: Baseline, 3, 6 and 12 month

    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl)

  2. Weight

    Time frame: Baseline, 3, 6 and 12 month

    weight

  3. Hypoglycemic events

    Time frame: Baseline, 3, 6 and 12 month

    Number of hypoglycemic events

  4. Treatment satisfaction

    Time frame: 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.

  5. Self-defined objectives

    Time frame: 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

  6. The quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rosa María Sánchez Hernández

Other

Collaborators

  • Ana M. Wägner
  • Angelines Jiménez-Rodríguez
  • Armando Carrillo-Domínguez
  • Dácil Alvarado-Martel
  • Francisco J Nóvoa-Mogollón
  • Julia Rodríguez-Cordero
  • Yaiza López-Plasencia

Registry information

Official study 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

Acronym: ANAIS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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