INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Not Applicable
Completed
- Conditions
- Metabolic Impact
- Interventions
- Device: telemedicine
- Registration Number
- NCT02784236
- Lead Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description pre-post evaluation telemedicine All patients undergo the condition of telemedicine.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
FIMABIS
🇪🇸Malaga, Spain