NCT04900636

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

September 8, 2023

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

May 18, 2021

Last Update Submit

September 7, 2023

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Metabolic control

    12 months

Study Arms (2)

Telemedicine Arm

EXPERIMENTAL

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

Device: Telemedicine Arm

Control Arm

NO INTERVENTION

conventional follow-up according to routine clinical practice.

Interventions

Telemedicine ArmDEVICE

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.

Telemedicine Arm

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lía Nattero Chávez

Madrid, Please Select, 28034, Spain

Location

Related Publications (2)

  • Nattero-Chavez L, de La Calle E, Lecumberri-Pascual E, Bayona Cebada A, Ruiz Gracia T, Quintero Tobar A, Lorenzo Monino M, Sanchez Rodriguez C, Izquierdo A, Escobar-Morreale HF, Luque-Ramirez M. Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes. Ther Adv Endocrinol Metab. 2024 Oct 25;15:20420188241288789. doi: 10.1177/20420188241288789. eCollection 2024.

    PMID: 39493410DERIVED

  • Nattero-Chavez L, Lecumberri Pascual E, De La Calle E, Bayona Cebada A, Ruiz T, Quintero Tobar A, Lorenzo M, Sanchez C, Izquierdo A, Luque-Ramirez M, Escobar-Morreale HF. 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. Diabetes Res Clin Pract. 2023 May;199:110627. doi: 10.1016/j.diabres.2023.110627. Epub 2023 Mar 20.

    PMID: 36940793DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lía Nattero Chávez, MD PhD

    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)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 25, 2021

Study Start

May 1, 2021

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

September 8, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)