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

February 3, 2017 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain, 29010
        • FIMABIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with DM1 plus 1 year of evolution.
  • Age ≥18 and <65 years.
  • HbA1c prior to study inclusion> 7%.
  • MDI intensive insulin therapy in basal-bolus regimen.
  • Patients candidates for telemonitoring. Approximately 50% of the patients should work with phone or tablet with Android operating system with active data rate to use wireless solution (bluetooth) OnLine MenaDiab® telemedicine. The remaining patients will work with the USB cable solution telemedicine MenaDiab® OnLine.
  • Patients who have given written informed consent.

Exclusion Criteria:

  • Treatment with ISCI.
  • Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled).
  • Pregnant or planning pregnancy.
  • Diabetes mellitus type 2.
  • Severe psychological disorders.
  • Lack of cooperation (informed consent).
  • Patients who are participating in other clinical studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pre-post evaluation
All patients undergo the condition of telemedicine.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY TC MENARINI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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