HypoglycemiaINSULINCOMNCT04595383
Electronic Platform for Diabetic Patients Activation
A study testing ti.care in people with Hypoglycemia and Hypoglycemia Acute, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia, Hypoglycemia Acute
- What is being tested?
- ti.care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
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.
Read the 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.
- Conditions
- Hypoglycemia, Hypoglycemia Acute
- Being tested
- ti.care
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ti.careDevice
Electronic platform for doctor-patient communication
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care and usual communication with health professional |
| Intervention | Experimental | 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. Receives: Device: ti.care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from HbA1c level at 3 months
Change from HbA1c level at 3 months
Measured: Baseline and at 3 months
Change from basal capillary blood glucose at 3 months
Change from basal capillary blood glucose at 3 months
Measured: Baseline and at 3 months
Change from postprandial blood glucose at 3 months
Change from postprandial blood glucose at 3 months
Measured: Baseline and at 3 months
Change from nocturnal blood glucose at 3 months
Change from nocturnal blood glucose at 3 months
Measured: Baseline and at 3 months
Total hypoglycemia
Number of total hypoglycemia events
Measured: At 3 months
Number of nocturnal hypoglycemia events
Number of nocturnal hypoglycemia events
Measured: At 3 months
Number of inadvertent hypoglycemia events
Number of inadvertent hypoglycemia events
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Oct 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domingo Orozco, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595383
- Sponsor's protocol ID
- 2020/09
- Acronym
- INSULINCOM
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
- ClinicalTrials.gov ID
- NCT04595383
- Acronym / sponsor ID
- INSULINCOM / 2020/09
- Conditions
- Hypoglycemia, Hypoglycemia Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care and usual communication with health professional |
| Intervention | Experimental | Device: ti.careThey 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with type 1 diabetes diagnosis
- Life expectancy less than one year
- Pregnancy
- Patients with dementia
- Patients with treatment different to insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ti.careElectronic platform for doctor-patient communication | Device | Intervention |
Primary outcome
Change from HbA1c level at 3 months
Time frame: Baseline and at 3 months
Change from HbA1c level at 3 months
Change from basal capillary blood glucose at 3 months
Time frame: Baseline and at 3 months
Change from basal capillary blood glucose at 3 months
Change from postprandial blood glucose at 3 months
Time frame: Baseline and at 3 months
Change from postprandial blood glucose at 3 months
Change from nocturnal blood glucose at 3 months
Time frame: Baseline and at 3 months
Change from nocturnal blood glucose at 3 months
Total hypoglycemia
Time frame: At 3 months
Number of total hypoglycemia events
Number of nocturnal hypoglycemia events
Time frame: At 3 months
Number of nocturnal hypoglycemia events
Number of inadvertent hypoglycemia events
Time frame: At 3 months
Number of inadvertent hypoglycemia events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ti.care in people with Hypoglycemia and Hypoglycemia Acute, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from HbA1c level at 3 months (time frame: Baseline and at 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.