NCT04883372

Brief Summary

The purpose of this study is to assess glycemic control changes in insulin-treated patients with diabetes using a continuous glucose monitoring CGM system through the ETAPES telemedicine program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 22, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

17 days

First QC Date

May 6, 2021

Last Update Submit

June 17, 2021

Conditions

Diabetes

Keywords

Telemedicinetelemonitoringdiabetescontinuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

  • glycated hemoglobin

    glycated hemoglobin

    at 3 months

  • glycated hemoglobin

    glycated hemoglobin

    at 6 months

Secondary Outcomes (6)

  • glycated hemoglobin

    at 3 months

  • glycated hemoglobin

    at 6 months

  • Time above target (TAR)

    at 3 months

  • Time above target (TAR)

    at 6 months

  • Time spent below target (TBR)

    at 3 months

  • +1 more secondary outcomes

Interventions

continuous glucose monitoringOTHER

a continuous glucose monitoring CGM system through the ETAPES telemedicine program

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

insulin-treated diabetic patients

You may qualify if:

  • new onset diabetes (\< 6 months) or diabetes duration \> 6 months with HbA1C ≥ 8% twice over the last 6 months in people aged over 18 years
  • new onset diabetes (\< 6 months) or diabetes duration \> 6 months with HbA1C ≥ 8.5% twice over the last 6 months in people aged between 12 and 17 years.

You may not qualify if:

  • patients objecting to research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 12, 2021

Study Start

May 22, 2021

Primary Completion

June 8, 2021

Study Completion

June 8, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)