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

NCT02784236 | Completed

• 1 other identifier: STUDY TC MENARINI
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  6 months

Study Arms (1)

pre-post evaluation

OTHER

All patients undergo the condition of telemedicine.

Device: telemedicine

Interventions

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

pre-post evaluation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with DM1 plus 1 year of evolution.
• Age ≥18 and \<65 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

FIMABIS

Málaga, Malaga, 29010, Spain

Location

Study Officials

• MARIA SOLEDAD RUIZ DE ADANA, MD phD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 27, 2016
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)