Telemedicine for Patients With an Hybrid Closed Loop System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Telemedicine Program in Type 1 Diabetes and CSII

NCT02790645

Diabetes Mellitus, Type 1

COMPLETED NA

Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

NCT02463097

Type 1 Diabetes

COMPLETED NA

Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System

NCT06363916

Type 1 Diabetes

RECRUITING

Real-life Data from Diabetic Patients on Closed-loop Pumps

NCT05418699

Type 1 Diabetes

ACTIVE_NOT_RECRUITING

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

NCT01966393

Type 1 Diabetes

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telemedicine Arm

Use of a telemedicine platform combined with face-to-face visits according to protocol

Group Type EXPERIMENTAL

Telemedicine Arm

Intervention Type 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.

Control Arm

conventional follow-up according to routine clinical practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telemedicine Arm

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lía Nattero Chávez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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)