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INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.

NCT02784236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2017-02-06

No results posted yet for this study

Summary

Prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (MDI) and HbA1c\> 7%. Patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI), treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R), quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.

Conditions

  • Metabolic Impact

Interventions

DEVICE

telemedicine

The study population corresponds to patients\> 18 and \<65 years with DM1 of\> 1 year of evolution, and treated with MDI HbA1c\> 7%. It is changing one group of subjects between two observation times due to any intervention in this case the addition of a tele

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • MARIA SOLEDAD RUIZ DE ADANA, MD phD · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784236 on ClinicalTrials.gov