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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02784236

Enrollment

121

Registered

2016-05-27

Start date

2014-04-30

Completion date

2016-09-30

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Impact

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.

Interventions

DEVICEtelemedicine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026