ANAIS, a Spanish Version of the DAFNE Programme (ANAIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Immediate ANAIS

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate ANAIS; Participants that attend the training course immediately.	Behavioral: Immediate 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.
No Intervention: Delayed ANAIS; Participants that attend the training course a year later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Glycated hemoglobin	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipids	Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl)	Baseline, 3, 6 and 12 month
Weight	weight	Baseline, 3, 6 and 12 month
Hypoglycemic events	Number of hypoglycemic events	Baseline, 3, 6 and 12 month
Treatment satisfaction	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.	Baseline, 3, 6 and 12 month
Self-defined objectives	Participants were asked to establish a maximum of 3 personal goals they wanted to achieve related to taking part in the programme	Baseline, 3, 6 and 12 month
The quality of life	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.	Baseline, 3, 6 and 12 month

Collaborators and Investigators

• Sponsor: Rosa María Sánchez Hernández
• Collaborators: Ana M. Wägner; Dácil Alvarado-Martel; Yaiza López-Plasencia; Armando Carrillo-Domínguez; Julia Rodríguez-Cordero; Francisco J Nóvoa-Mogollón; Angelines Jiménez-Rodríguez

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; type 1 diabetes; patient empowerment; education programme; dietary freedom
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ANAIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No