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

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

Status

Completed

Conditions

Metabolic Impact

Treatments

Device: telemedicine

Study type

Interventional

Funder types

Other

Identifiers

NCT02784236

STUDY TC MENARINI

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.