Prognostic Impact of Diabetes and Weight Variability in Telemonitored Heart Failure (DM-HF-Tele)

April 24, 2026 updated by: Satelia

Impact of Diabetes, Short-term Weight Variability, Heart Failure Etiologies and Other Comorbidities on Survival in a National Telemonitored Heart Failure Cohort

This observational cohort study evaluates the prognostic impact of diabetes, comorbidity burden, and short-term weight variability among adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France. Patients were enrolled between September 3 2018 and April 3 2024 as part of routine heart failure care. Baseline demographic, clinical, and treatment data, along with weight measurements collected through telemonitoring, were analyzed. The study aims to assess associations between diabetes status, multimorbidity, and weight variability with survival outcomes using retrospective data from the program database. No study-mandated interventions were performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective, multicenter observational cohort study was conducted using data from a nationwide heart failure remote patient monitoring program in France. The program supports routine clinical management of patients with chronic heart failure through digital symptom and weight monitoring, automated alerts, and coordination with healthcare providers.

The study includes adult patients enrolled between September 2018 and April 2024. Clinical characteristics recorded at enrollment were extracted from the program database, including demographics, heart failure severity indicators, comorbid conditions, and treatment information. Repeated weight measurements obtained during telemonitoring were used to calculate short-term weight variability as a marker of dynamic physiological status.

The primary objective is to evaluate the association between diabetes and survival in patients with chronic heart failure. Secondary objectives include assessment of the impact of overall comorbidity burden and short-term weight variability on survival, as well as exploration of interactions between diabetes, age, and multimorbidity.

All treatments and monitoring were part of routine care. No interventions were assigned by the study protocol. Statistical analyses include survival modeling and multivariable adjustment to identify independent predictors of outcomes.

Study Type

Observational

Enrollment (Actual)

16556

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Satelia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

he study population consists of adults with chronic heart failure in France who were enrolled in a nationwide remote patient monitoring program between September 2018 and April 2024 as part of routine clinical care. Patients entered the program following hospitalization for heart failure or in the ambulatory setting based on clinical criteria consistent with heart failure management. The cohort includes individuals with and without diabetes and represents patients managed across a range of healthcare settings, including university hospitals, non-university hospitals, and outpatient practices.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of chronic heart failure
  • Enrolment in the national heart failure remote monitoring program between September 3, 2018, and April 3, 2024
  • Availability of baseline clinical data including diabetes status

Exclusion Criteria:

  • Missing baseline information on diabetes status
  • Missing follow-up data for survival status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Failure Telemonitoring Cohort
Adults with chronic heart failure enrolled in a nationwide remote patient monitoring program in France between September 2018 and April 2024. Clinical characteristics at enrolment and weight measurements collected during routine telemonitoring were analyzed to evaluate associations between diabetes, comorbidity burden, weight variability, and survival outcomes in routine care.
Other: Diabetes Status
Presence or absence of diabetes mellitus recorded at enrolment as part of routine clinical assessment.
Other: Comorbidity Burden
Number of chronic comorbid conditions recorded at enrollment, used as a measure of multimorbidity.
Other: Weight variability
Short-term variability in body weight calculated from repeated weight measurements collected during routine telemonitoring, used as a marker of dynamic physiological status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Diabetes Status and All-Cause Mortality
Time Frame: From enrolment up to 3 years of follow-up
Relationship between the presence of diabetes mellitus at enrolment and subsequent risk of death, evaluated using multivariable survival analysis.
From enrolment up to 3 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: From enrolment in the remote monitoring program up to 3 years of follow-up
Time from enrolment to death from any cause, assessed using follow-up data collected during routine care within the remote monitoring program.
From enrolment in the remote monitoring program up to 3 years of follow-up
Association Between Comorbidity Burden and All-Cause Mortality
Time Frame: From enrolment up to 3 years of follow-up
Association between the number of chronic comorbid conditions at enrolment and risk of death during follow-up.
From enrolment up to 3 years of follow-up
Association Between Short-Term Weight Variability and All-Cause Mortality
Time Frame: From enrolment up to 3 years of follow-up
Relationship between short-term variability in body weight measured during telemonitoring and subsequent risk of death
From enrolment up to 3 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satelia

Investigators

  • Principal Investigator: Paul Valensi, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

April 3, 2024

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-HF-Tele

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected for this study are derived from a national telemonitoring program and contain sensitive health information. Data sharing is restricted due to patient privacy protections and applicable European data protection regulations (GDPR). Access to de-identified data may be considered upon reasonable request and subject to appropriate data protection agreements and regulatory approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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