Telemedicine for Patients With an Hybrid Closed Loop System
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telemedicine Arm
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Diagnostic criteria for DM1 according to ADA
- They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
- Acceptance of participation in the study and signing of the informed consent
Exclusion Criteria:
- Gestation
- Institutionalization, serious or terminal illness or renal replacement therapy.
- Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
- Refusal to participate in the study or to sign the informed consent
Sites / Locations
- Lía Nattero Chávez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemedicine Arm
Control Arm
Arm Description
Use of a telemedicine platform combined with face-to-face visits according to protocol
conventional follow-up according to routine clinical practice.
Outcomes
Primary Outcome Measures
Impact on quality of life
Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are:
Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome
Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome
Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and
Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.
Secondary Outcome Measures
Metabolic control
A1c levels
Full Information
NCT ID
NCT04900636
First Posted
May 18, 2021
Last Updated
September 7, 2023
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT04900636
Brief Title
Telemedicine for Patients With an Hybrid Closed Loop System
Official Title
A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Arm
Arm Type
Experimental
Arm Description
Use of a telemedicine platform combined with face-to-face visits according to protocol
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
conventional follow-up according to routine clinical practice.
Intervention Type
Device
Intervention Name(s)
Telemedicine Arm
Intervention Description
Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol.
Primary Outcome Measure Information:
Title
Impact on quality of life
Description
Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are:
Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome
Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome
Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and
Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Metabolic control
Description
A1c levels
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic criteria for DM1 according to ADA
They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
Acceptance of participation in the study and signing of the informed consent
Exclusion Criteria:
Gestation
Institutionalization, serious or terminal illness or renal replacement therapy.
Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
Refusal to participate in the study or to sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lía Nattero Chávez, MD PhD
Organizational Affiliation
Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lía Nattero Chávez
City
Madrid
State/Province
Please Select
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine for Patients With an Hybrid Closed Loop System
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