Back to resultsINTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Primary Purpose
Metabolic Impact
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
telemedicine
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Impact
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.
Sites / Locations
- FIMABIS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pre-post evaluation
Arm Description
All patients undergo the condition of telemedicine.
Outcomes
Primary Outcome Measures
To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
Secondary Outcome Measures
Full Information
NCT ID
NCT02784236
First Posted
May 24, 2016
Last Updated
February 3, 2017
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
1. Study Identification
Unique Protocol Identification Number
NCT02784236
Brief Title
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Official Title
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Impact
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-post evaluation
Arm Type
Other
Arm Description
All patients undergo the condition of telemedicine.
Intervention Type
Device
Intervention Name(s)
telemedicine
Intervention Description
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
Primary Outcome Measure Information:
Title
To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA SOLEDAD RUIZ DE ADANA, MD phD
Organizational Affiliation
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Official's Role
Principal Investigator
Facility Information:
Facility Name
FIMABIS
City
Malaga
ZIP/Postal Code
29010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
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