NCT04758884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

September 20, 2024

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 25, 2021

Last Update Submit

September 18, 2024

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetesTelemedicineMetabolic control

Outcome Measures

Primary Outcomes (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.

    HbA1c (%)

    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.

    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.

    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.

    6 months

  • Differences in terms of glucometry in a group of patients with T1D followed by telemedicine versus to the usual management in consultation.

    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.

    6 months

  • +2 more secondary outcomes

Study Arms (2)

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).

Other: Telemedicine

Conventional management group

NO INTERVENTION

Initial visit, 3 and 6 months.

Interventions

TelemedicineOTHER

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

Telemedicine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Comarcal de l'Alt Penedès

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

Related Publications (3)

  • Ballesta 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.

    PMID: 37441496BACKGROUND

  • 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.

    PMID: 27196443BACKGROUND

  • Peterson 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.

    PMID: 24876414BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Juan José Chillarón, Ph.D.

    Consorci Sanitari de l'Alt Penedès

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 17, 2021

Study Start

January 9, 2021

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

September 20, 2024

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)