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

Metabolic Impact Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784236
• Other study ID #: STUDY TC MENARINI
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: February 3, 2017
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Metabolic Impact

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	FIMABIS	Malaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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