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

NCT ID: NCT02784236

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

pre-post evaluation

All patients undergo the condition of telemedicine.

Group Type: OTHER

telemedicine

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARIA SOLEDAD RUIZ DE ADANA, MD phD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

FIMABIS

Málaga, Malaga, Spain

Countries

Spain

Other Identifiers

STUDY TC MENARINI

Identifier Type: -

Identifier Source: org_study_id