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OpenTrials
Completed

NCT Number: NCT04900636

Telemedicine for Patients With an Hybrid Closed Loop System

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lía Nattero Chávez

Madrid, Please Select, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine Arm

Device

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 outcomes

  1. Impact on quality of life

    Time frame: 12 months

    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 outcomes

  1. Metabolic control

    Time frame: 12 months

    A1c levels

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 25, 2021
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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