Telemedicine for Patients With an Hybrid Closed Loop System

Conditions

Diabetes Mellitus, Type 1

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.

Nattero-Chávez L, de La Calle E, Lecumberri-Pascual E, Bayona Cebada A, Ruiz Gracia T, Quintero Tobar A, Lorenzo Moñino M, Sánchez Rodríguez C, Izquierdo A, Escobar-Morreale HF, Luque-Ramírez M.

2024-10-251 citations

10.1177/20420188241288789

Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms.

Nattero-Chávez L, Lecumberri Pascual E, De La Calle E, Bayona Cebada A, Ruiz T, Quintero Tobar A, Lorenzo M, Sánchez C, Izquierdo A, Luque-Ramírez M, Escobar-Morreale HF.

2023-03-2011 citations

10.1016/j.diabres.2023.110627

Interventions

DEVICETelemedicine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Impact on quality of life	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

Measure	Time frame	Description
Metabolic control	12 months	A1c levels

Countries

Spain

Outcome results

None listed