Diabetes Mellitus, Type 1NCT04758884
Telemedicine in Patients With Type 1 Diabetes Mellitus.
A study testing Telemedicine in people with Diabetes Mellitus, Type 1, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
Management of patients with type 1 Diabetes Mellitus has been changing rapidly in recent years, due in part to the introduction of new technologies such as Apps that recommend insulin boluses, or the use of continuous blood glucose sensors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2021to 2 Feb 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
- Patients with T1D over 18 years of age
- Duration of T1D greater than 6 months
- Access to smartphones
- In those patients with CGM, the minimum time for handling the sensor before randomization will be 2 months.
Who cannot join
- Inability to handle smartphones or Apps to manage T1D.
- Admission due to acute decompensation of TD1 in previous 3 months, presence of more than one severe monthly hypoglycemia, or any other circumstance that requires frequent visits and intensive diabetes education
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Comarcal de l'Alt Penedès
Vilafranca del Penedès, Barcelona, 08720
About this study
Official title: Telemedicine in Patients With Type 1 Diabetes Mellitus. Efficacy Study of a Specific Virtual Consultation.
Management of patients with type 1 Diabetes Mellitus has been changing rapidly in recent years, due in part to the introduction of new technologies such as Apps that recommend insulin boluses, or the use of continuous blood glucose sensors. This fact also entails a change in the care the investigators provide to these patients, facilitating virtual interaction without the need for the patient to go to the consultation, but having all the information necessary to modify treatment doses. There are no studies that compare the influence on glycemic control of conventional management with respect to virtual visits.
The investigators have proposed a randomized cohort study, with the aim to compared the changes in glycated hemoglobin in a group of patients with DM1 of the reference area of the "Hospital Comarcal de l´Alt Penedès" followed by telemedicine respect to the usual management in presential consultation.
Read the detailed description
Classic management of patients with type 1 diabetes (T1D) by endocrinologists consisted of carrying out a visit every 3-6 months in which HbA1c, microalbuminuria and a notebook with a variable number of annotated controls had been reviewed. In an accelerated way, the management of T1D has clearly been modified with the irruption of new technologies. Devices such as insulin bolus calculators, continuous glucose sensors, or continuous insulin pumps have been appeared and improved. In last months, continuous glucose monitors (CGM) for patients with T1D have been included in public funding in some cases. This fact is also associated with a considerable increase in the number of patient data, and new parameters to analyzed have appeared, with the same importance as HbA1c. Thus, percentage of time in optimal glycemic range, percentage of time in hypoglycemia, coefficient of variation of glycemia, or the mean glycemia are new parameters that the investigators have now been included in the follow-up.
The handling of such amount of data has mainly two repercussions: on the one hand, if these data are well analyzed it is easier to make changes in the treatment, which can conduce to a better disease management such as an improvement in metabolic control or a reduction in hypoglycemia number events. On the other hand, in routine clinical practice it has been found that the fact that patients have higher number of data raises more doubts about theirs treatment and other aspects of their disease, which motivate a greater number of consultations, usually telephone or unscheduled, generating a greater delay in the consultation, occupying spaces assigned to the emergency room or in time slots assigned to other patients.
In this way, telemedicine could be very useful in T1D management. These new devices allow data to be downloaded on secure digital platforms that make it possible for the doctor to have all the patient's blood glucose data without the presential visit of patient to hospital. Some of these platforms also allow safe communication channels between doctors and patients (teleconference, chats). The main benefit that telemedicine can provide is that allow doctors have a very narrow control, unacceptable in routine practice, which allows to interpreted the large volume of data that is generated and to do treatment recommendations, which can improve the metabolic control of the patient.
To date there are few studies on telemedicine in T1D. In this regard, a systematic review reported promising data in terms of HbA1c reduction in 3-6 months interventions, although it do not allow a robust conclusion due to the heterogeneity of the intervention in included studies, the absence of a control group and the small number of patients included2.
Furthermore, the benefits of telemedicine in management of T1D may go beyond the improvement of metabolic control. It must be considered that most T1D patients are young people of working age and that in some areas such as "l´Alt Penedès" there is an important geographical dispersion.
Thus, telemedicine could reduce trips to hospital with benefits on quality of life and reduce indirect costs such as travel costs, lost working hours, etc. In this sense, the Coyote study, carried out in the United States with a sample of 40 T1D subjects between 18-25 years of age, demonstrated that telemedicine was capable of improving the quality of life and saving 6 hours on average between travel to hospital, medical visit and return to work or university1. It should be noted that this study, which is considered a benchmark in its field, did not have a control group nor did it study changes in metabolic control.
On the other hand, being able to establish virtual contact channels between the patient and the doctor with a quick response from the doctor can be reflected in a reduction in the number of unexpected visits or contacts with the Emergency Department. Finally, it must be considered that virtual visits, although they are more frequent than face-to-face ones, are shorter and therefore the total time that doctor spends with the patient does not have to be superior to conventional management.
Hypothesis: Use of telemedicine in patients with T1D allows a closer control of their disease that results in a improve of metabolic control without increasing the number of face-to-face visits.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Telemedicine
- Keywords
- Type 1 diabetes, Telemedicine, Metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Visits by videoconference in months 0, 1, 2, 3, 4 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine group | Experimental | Visits by videoconference in months 0, 1, 2, 3, 4 and 6. Additionally, availability to send intermediate messages with a response from the endocrine in less than 72 hours.
The videoconference will be held safely through the SocialDiabetes® App. Patients will be provided with a glucometer that transfers the data directly to the App without the patient having to enter it to avoid bias in time and value. Videoconferences will NOT be recorded.
Patients with CGM will additionally have all their values on the platform that corresponds to their sensor (Libreview® for the Freesyle libre® sensor and Clarity® for the Dexcom G5 sensor). Receives: Other: Telemedicine |
| Conventional management group | No intervention | Initial visit, 3 and 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare changes in HbA1c at 6 months in a group of patients with T1D in the reference area of the "Hospital Comarcal de l´Alt Penedès" followed by telemedicine versus to the usual management in consultation.
HbA1c (%)
Measured: 6 months
Secondary outcomes (7)
Differences in terms of HbA1c at 3 months in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
HbA1c at 3 months (%)
Measured: 3 months
Differences in terms of Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) (score, minimum value = 43, maximum value = 215, higher scores mean a worse outcome. ).
Measured: 6 months
Differences in terms of episodes of symptomatic hypoglycemia in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Episodes of symptomatic hypoglycemia (number).
Measured: 6 months
Differences in terms of glucometry in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Glucometry: Time in range, above and below range in those patients with CGM (%).
Measured: 6 months
Differences in terms of total time spent by endocrinologist in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Total time spent by endocrinologist (hours).
Measured: 6 months
Differences in terms of indirect costs in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Indirect costs (euros).
Measured: 6 months
Differences in terms of number of unplanned contacts with the specialist in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Number of unplanned contacts with the specialist (number).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start9 Jan 2021
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan José Chillarón, Ph.D., Principal investigator, Consorci Sanitari de l'Alt Penedès
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758884
- Sponsor's protocol ID
- CSAPG-05
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.
PubMed 27196443Peterson A. Improving type 1 diabetes management with mobile tools: a systematic review. J Diabetes Sci Technol. 2014 Jul;8(4):859-64. doi: 10.1177/1932296814529885. Epub 2014 Apr 9.
PubMed 24876414Ballesta S, Chillaron JJ, Inglada Y, Climent E, Llaurado G, Pedro-Botet J, Cots F, Camell H, Flores JA, Benaiges D. Telehealth model versus in-person standard care for persons with type 1 diabetes treated with multiple daily injections: an open-label randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1176765. doi: 10.3389/fendo.2023.1176765. eCollection 2023.
PubMed 37441496
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Patients With Type 1 Diabetes Mellitus. Efficacy Study of a Specific Virtual Consultation.
- ClinicalTrials.gov ID
- NCT04758884
- Acronym / sponsor ID
- CSAPG-05
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, Telemedicine, Metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 17 Feb 2021 (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.
Management of patients with type 1 Diabetes Mellitus has been changing rapidly in recent years, due in part to the introduction of new technologies such as Apps that recommend insulin boluses, or the use of continuous blood glucose sensors. This fact also entails a change in the care the investigators provide to these patients, facilitating virtual interaction without the need for the patient to go to the consultation, but having all the information necessary to modify treatment doses. There are no studies that compare the influence on glycemic control of conventional management with respect to virtual visits.
The investigators have proposed a randomized cohort study, with the aim to compared the changes in glycated hemoglobin in a group of patients with DM1 of the reference area of the "Hospital Comarcal de l´Alt Penedès" followed by telemedicine respect to the usual management in presential consultation.
Detailed description
Classic management of patients with type 1 diabetes (T1D) by endocrinologists consisted of carrying out a visit every 3-6 months in which HbA1c, microalbuminuria and a notebook with a variable number of annotated controls had been reviewed. In an accelerated way, the management of T1D has clearly been modified with the irruption of new technologies. Devices such as insulin bolus calculators, continuous glucose sensors, or continuous insulin pumps have been appeared and improved. In last months, continuous glucose monitors (CGM) for patients with T1D have been included in public funding in some cases. This fact is also associated with a considerable increase in the number of patient data, and new parameters to analyzed have appeared, with the same importance as HbA1c. Thus, percentage of time in optimal glycemic range, percentage of time in hypoglycemia, coefficient of variation of glycemia, or the mean glycemia are new parameters that the investigators have now been included in the follow-up.
The handling of such amount of data has mainly two repercussions: on the one hand, if these data are well analyzed it is easier to make changes in the treatment, which can conduce to a better disease management such as an improvement in metabolic control or a reduction in hypoglycemia number events. On the other hand, in routine clinical practice it has been found that the fact that patients have higher number of data raises more doubts about theirs treatment and other aspects of their disease, which motivate a greater number of consultations, usually telephone or unscheduled, generating a greater delay in the consultation, occupying spaces assigned to the emergency room or in time slots assigned to other patients.
In this way, telemedicine could be very useful in T1D management. These new devices allow data to be downloaded on secure digital platforms that make it possible for the doctor to have all the patient's blood glucose data without the presential visit of patient to hospital. Some of these platforms also allow safe communication channels between doctors and patients (teleconference, chats). The main benefit that telemedicine can provide is that allow doctors have a very narrow control, unacceptable in routine practice, which allows to interpreted the large volume of data that is generated and to do treatment recommendations, which can improve the metabolic control of the patient.
To date there are few studies on telemedicine in T1D. In this regard, a systematic review reported promising data in terms of HbA1c reduction in 3-6 months interventions, although it do not allow a robust conclusion due to the heterogeneity of the intervention in included studies, the absence of a control group and the small number of patients included2.
Furthermore, the benefits of telemedicine in management of T1D may go beyond the improvement of metabolic control. It must be considered that most T1D patients are young people of working age and that in some areas such as "l´Alt Penedès" there is an important geographical dispersion.
Thus, telemedicine could reduce trips to hospital with benefits on quality of life and reduce indirect costs such as travel costs, lost working hours, etc. In this sense, the Coyote study, carried out in the United States with a sample of 40 T1D subjects between 18-25 years of age, demonstrated that telemedicine was capable of improving the quality of life and saving 6 hours on average between travel to hospital, medical visit and return to work or university1. It should be noted that this study, which is considered a benchmark in its field, did not have a control group nor did it study changes in metabolic control.
On the other hand, being able to establish virtual contact channels between the patient and the doctor with a quick response from the doctor can be reflected in a reduction in the number of unexpected visits or contacts with the Emergency Department. Finally, it must be considered that virtual visits, although they are more frequent than face-to-face ones, are shorter and therefore the total time that doctor spends with the patient does not have to be superior to conventional management.
Hypothesis: Use of telemedicine in patients with T1D allows a closer control of their disease that results in a improve of metabolic control without increasing the number of face-to-face visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | Experimental | Other: TelemedicineVisits by videoconference in months 0, 1, 2, 3, 4 and 6. Additionally, availability to send intermediate messages with a response from the endocrine in less than 72 hours. The videoconference will be held safely through the SocialDiabetes® App. Patients will be provided with a glucometer that transfers the data directly to the App without the patient having to enter it to avoid bias in time and value. Videoconferences will NOT be recorded. Patients with CGM will additionally have all their values on the platform that corresponds to their sensor (Libreview® for the Freesyle libre® sensor and Clarity® for the Dexcom G5 sensor). |
| Conventional management group | No intervention | –Initial visit, 3 and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with T1D over 18 years of age
- Duration of T1D greater than 6 months
- Access to smartphones
- In those patients with CGM, the minimum time for handling the sensor before randomization will be 2 months.
Key exclusion criteria (3 listed)
- Inability to handle smartphones or Apps to manage T1D.
- Admission due to acute decompensation of TD1 in previous 3 months, presence of more than one severe monthly hypoglycemia, or any other circumstance that requires frequent visits and intensive diabetes education
- Inability to sign the informed consent
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 |
|---|---|---|
| TelemedicineVisits by videoconference in months 0, 1, 2, 3, 4 and 6. | Other | Telemedicine group |
Primary outcome
To compare changes in HbA1c at 6 months in a group of patients with T1D in the reference area of the "Hospital Comarcal de l´Alt Penedès" followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
HbA1c (%)
7 secondary outcomes
Differences in terms of HbA1c at 3 months in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 3 months
Differences in terms of Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Differences in terms of episodes of symptomatic hypoglycemia in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Differences in terms of glucometry in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Differences in terms of total time spent by endocrinologist in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Differences in terms of indirect costs in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Differences in terms of number of unplanned contacts with the specialist in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 27196443Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.
- Background: PubMed 24876414Peterson A. Improving type 1 diabetes management with mobile tools: a systematic review. J Diabetes Sci Technol. 2014 Jul;8(4):859-64. doi: 10.1177/1932296814529885. Epub 2014 Apr 9.
- Results publication: PubMed 37441496Ballesta S, Chillaron JJ, Inglada Y, Climent E, Llaurado G, Pedro-Botet J, Cots F, Camell H, Flores JA, Benaiges D. Telehealth model versus in-person standard care for persons with type 1 diabetes treated with multiple daily injections: an open-label randomized controlled trial. Front Endocrinol (Lausanne). 2023 Jun 27;14:1176765. doi: 10.3389/fendo.2023.1176765. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Juan José Chillarón, Ph.D. principal investigator
Consorci Sanitari de l'Alt Penedès
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Diabetes Mellitus, Type 1, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare changes in HbA1c at 6 months in a group of patients with T1D in the reference area of the "Hospital Comarcal de l´Alt Penedès" followed by telemedicine versus to the usual management in consultation. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758884, which also lists 3 linked publications.
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 20 Sep 2024.