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Clinical Trial NCT04883372 (TLS-DIAB) for Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Study of the Effect of Telemedicine on Glycemic Control for Patients With Diabetes and Treated With Insulin (TLS-DIAB) 64
Clinical Trial NCT04883372 (TLS-DIAB) was an observational study for Diabetes that is now completed. The study started on May 22, 2021, with plans to enroll 64 participants. Led by Centre Hospitalier Sud Francilien, the expected completion date was June 8, 2021. The latest data from ClinicalTrials.gov was last updated on June 18, 2021.
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.
Detailed Description
Diabetes is currently one of the major health challenges. According to the International Diabetes Federation (IDF), the number of people with diabetes has tripled in the last 20 years and will reach 463 million cases in 2020. This chronic disease causes degenerative complications that affect the quality of life of patients and increase the morbidity and mortality rate. This is due to limited access to health professi...Show More
Official Title
Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.
Conditions
DiabetesOther Study IDs
- TLS-DIAB
- 2021/0013
NCT ID Number
Start Date (Actual)
2021-05-22
Last Update Posted
2021-06-18
Completion Date (Estimated)
2021-06-08
Enrollment (Estimated)
64
Study Type
Observational
Status
Completed
Keywords
Telemedicine
telemonitoring
diabetes
continuous glucose monitoring
telemonitoring
diabetes
continuous glucose monitoring
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | continuous glucose monitoring a continuous glucose monitoring CGM system through the ETAPES telemedicine program |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
glycated hemoglobin | glycated hemoglobin | at 3 months |
glycated hemoglobin | glycated hemoglobin | at 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
glycated hemoglobin | time spent in the target | at 3 months |
glycated hemoglobin | time spent in the target | at 6 months |
Time above target (TAR) | Change in time above target (TAR) of hyperglycemia, \> 250 mg/dL, from 181 to 250 mg/dL | at 3 months |
Time above target (TAR) | Change in time above target (TAR) of hyperglycemia, \> 250 mg/dL, from 181 to 250 mg/dL | at 6 months |
Time spent below target (TBR) | Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and \< 54 mg/dL | at 3 months |
Time spent below target (TBR) | Change in time spent below target (TBR) of hypoglycemia from 54 to 69 mg/dL and \< 54 mg/dL | at 6 months |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
For people with T1D, inclusion criteria in the ETAPES program were:
- 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.
For people with T2D, inclusion criteria were diabetes duration > 12 months with HbA1C ≥ 9% twice over the last 6 months in people aged over 18 years.
- patients objecting to research
Centre Hospitalier Sud FrancilienNo contact data.
1 Study Locations in 1 Countries
Centre Hospitalier Sud Francilien, Corbeil-Essonnes, 91106, France