INSULINCOM: Electronic Platform for Diabetic Patients Activation

Sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04595383

Collaborator

(none)

106

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia Hypoglycemia Acute	Device: ti.care	N/A

Detailed Description

This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.

The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Usual care and usual communication with health professional
Experimental: Intervention They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits. This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method. The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator. It will be used in a preventive and advisory manner for the patient for follow-up. In no case it will be used for emergencies. Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.	Device: ti.care Electronic platform for doctor-patient communication

Arm

Intervention/Treatment

No Intervention: Control

Usual care and usual communication with health professional

Experimental: Intervention

They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits. This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method. The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator. It will be used in a preventive and advisory manner for the patient for follow-up. In no case it will be used for emergencies. Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.

Device: ti.care

Electronic platform for doctor-patient communication

Outcome Measures

Primary Outcome Measures

Change from HbA1c level at 3 months [Baseline and at 3 months]
Change from HbA1c level at 3 months
Change from basal capillary blood glucose at 3 months [Baseline and at 3 months]
Change from basal capillary blood glucose at 3 months
Change from postprandial blood glucose at 3 months [Baseline and at 3 months]
Change from postprandial blood glucose at 3 months
Change from nocturnal blood glucose at 3 months [Baseline and at 3 months]
Change from nocturnal blood glucose at 3 months
Total hypoglycemia [At 3 months]
Number of total hypoglycemia events
Number of nocturnal hypoglycemia events [At 3 months]
Number of nocturnal hypoglycemia events
Number of inadvertent hypoglycemia events [At 3 months]
Number of inadvertent hypoglycemia events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged over 17 years
Patients with type 2 diabetes diagnosis
Patients who start insulin treatment or with intensification of treatment
Patients who sign informed consent

Exclusion Criteria:

Patients with type 1 diabetes diagnosis
Life expectancy less than one year
Pregnancy
Patients with dementia
Patients with treatment different to insulin
Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Domingo Orozco, Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

ClinicalTrials.gov Identifier:

NCT04595383

Other Study ID Numbers:

2020/09

First Posted:

Oct 20, 2020

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoglycemia

Study Results

No Results Posted as of Mar 19, 2021