Skip to main content
OpenTrials
Completed

NCT Number: NCT02784236

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Impact

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FIMABIS

Málaga, Malaga, 29010, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Telemedicine

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Feb 6, 2017

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.