ANAIS, a Spanish Version of the DAFNE Programme

Diabetes Mellitus, Type 1 Clinical Trial

— ANAIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699189
• Other study ID #: ANAIS
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: October 2018
• Source: Hospital Universitario Insular Gran Canaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Glycated hemoglobin	1 year
Secondary	Lipids	Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein and triglycerides (all are expressed in mg/dl)	Baseline, 3, 6 and 12 month
Secondary	Weight	weight	Baseline, 3, 6 and 12 month
Secondary	Hypoglycemic events	Number of hypoglycemic events	Baseline, 3, 6 and 12 month
Secondary	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
Secondary	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
Secondary	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