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Telemedicine in Patients With Type 1 Diabetes Mellitus.

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ClinicalTrials.gov Identifier: NCT04758884
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Consorci Sanitari de l'Alt Penedès i Garraf

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Telemedicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telemedicine in Patients With Type 1 Diabetes Mellitus. Efficacy Study of a Specific Virtual Consultation.
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Telemedicine group

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).

Other: Telemedicine
Visits by videoconference in months 0, 1, 2, 3, 4 and 6.

No Intervention: Conventional management group
Initial visit, 3 and 6 months.



Primary Outcome Measures :
  1. 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 (%)


Secondary Outcome Measures :
  1. 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 ]
    HbA1c at 3 months (%)

  2. 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 ]
    Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) (score, minimum value = 43, maximum value = 215, higher scores mean a worse outcome. ).

  3. 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 ]
    Episodes of symptomatic hypoglycemia (number).

  4. 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 ]
    Glucometry: Time in range, above and below range in those patients with CGM (%).

  5. 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 ]
    Total time spent by endocrinologist (hours).

  6. 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 ]
    Indirect costs (euros).

  7. 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 ]
    Number of unplanned contacts with the specialist (number).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758884


Contacts
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Contact: Juan José Chillarón, Ph.D. +34 938 18 04 40 ext 10027 jjchillaron@csap.cat
Contact: Sílvia Ballesta, M.D. +34 938 18 04 40 ext 10027 sballesta@csap.cat

Locations
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Spain
Hospital Comarcal de l'Alt Penedès Recruiting
Vilafranca Del Penedès, Barcelona, Spain, 08720
Sponsors and Collaborators
Consorci Sanitari de l'Alt Penedès i Garraf
Investigators
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Principal Investigator: Juan José Chillarón, Ph.D. Consorci Sanitari de l'Alt Penedès
Publications:
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Responsible Party: Consorci Sanitari de l'Alt Penedès i Garraf
ClinicalTrials.gov Identifier: NCT04758884    
Other Study ID Numbers: CSAPG-05
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Consorci Sanitari de l'Alt Penedès i Garraf:
Type 1 diabetes
Telemedicine
Metabolic control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases