Study of the Effect of Telemedicine on Glycemic Control for Patients With Diabetes and Treated With Insulin (TLS-DIAB)

Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: continuous glucose monitoring

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 professionals, inadequate patient education and especially poor self-management of their disease which hinders adequate glycemic control of diabetes. The daily routine of a type 1 diabetic patient includes self-monitoring of blood glucose levels as well as several insulin injections per day or the use of an insulin pump. However, this treatment does not prevent the occurrence of micro and/or macroangiopathic complications, especially when the diabetes is poorly controlled. Therefore, optimal and large-scale glycemic control can have a significant clinical, social and economic impact. The Diabetes Control and Complications Trial (DCCT) has shown that intensive glycemic control delays or prevents the occurrence of microvascular and macrovascular complications. Intensive treatment, education and support for diabetes self-management improves glycated hemoglobin levels, reducing the risk of developing degenerative complications. This is accompanied by a positive psychosocial and behavioral effect. It is in this context that telemedicine, via remote monitoring, can improve glycemic control. Diabetes remains one of the most suitable specialties for telemedicine, especially with the advent of continuous glucose measurements reimbursed by health insurance since 2017.

Since the 1990s, several telemonitoring projects have demonstrated the value of constant support for diabetic patients, resulting in a significant improvement in HbA1c; the patient becomes an actor in his or her management, with better appropriation of the disease and better compliance. Remote monitoring is one of the 5 telemedicine procedures defined in France. It allows a medical professional to remotely interpret the data necessary for a patient's medical follow-up and to make decisions regarding the patient's care.

The French health authorities have set up national experiments on remote monitoring of diabetes under real conditions, such as the ETAPES program, whose objective is to evaluate the clinical, medico-economic and quality of life benefits of patients who benefit from remote monitoring. This program has 3 components: remote medical monitoring of patients including remote interpretation of patient results and adaptation of treatment, therapeutic support through face-to-face or remote sessions and the use of a remote monitoring platform that provides the link between the patient and the medical team.

In December 2019, the endocrinology department of the CHSF decided to implement the ETAPES program via the LIBREVIEW technical solution in order to better support unbalanced insulin-treated diabetic patients.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

insulin-treated diabetic patients

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• patients objecting to research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycated hemoglobin	glycated hemoglobin	at 3 months
glycated hemoglobin	glycated hemoglobin	at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2021
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; diabetes; continuous glucose monitoring; telemonitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2021/0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No