DiabetesTLS-DIABNCT04883372
Study of the Effect of Telemedicine on Glycemic Control for Patients With Diabetes and Treated With Insulin
An observational study of Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- continuous glucose monitoring
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2021to 8 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: insulin-treated diabetic patients
Who may be able to join
- 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.
Who cannot join
- patients objecting to research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- continuous glucose monitoring
- Keywords
- Telemedicine, telemonitoring, diabetes, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoringOther
a continuous glucose monitoring CGM system through the ETAPES telemedicine program
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
glycated hemoglobin
Measured: at 3 months
glycated hemoglobin
glycated hemoglobin
Measured: at 6 months
Secondary outcomes (6)
glycated hemoglobin
time spent in the target
Measured: at 3 months
glycated hemoglobin
time spent in the target
Measured: at 6 months
Time above target (TAR)
Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL
Measured: at 3 months
Time above target (TAR)
Change in time above target (TAR) of hyperglycemia, > 250 mg/dL, from 181 to 250 mg/dL
Measured: 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
Measured: 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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start22 May 2021
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883372
- Sponsor's protocol ID
- 2021/0013
- Acronym
- TLS-DIAB
- Status last verified
- Jun 2021
- First submitted
- 6 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.
- ClinicalTrials.gov ID
- NCT04883372
- Acronym / sponsor ID
- TLS-DIAB / 2021/0013
- Conditions
- Diabetes
- Keywords
- Telemedicine, telemonitoring, diabetes, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 22 May 2021 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- insulin-treated diabetic patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- patients objecting to research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous glucose monitoringa continuous glucose monitoring CGM system through the ETAPES telemedicine program | Other | – |
Primary outcome
glycated hemoglobin
Time frame: at 3 months
glycated hemoglobin
glycated hemoglobin
Time frame: at 6 months
glycated hemoglobin
6 secondary outcomes
glycated hemoglobin
Time frame: at 3 months
glycated hemoglobin
Time frame: at 6 months
Time above target (TAR)
Time frame: at 3 months
Time above target (TAR)
Time frame: at 6 months
Time spent below target (TBR)
Time frame: at 3 months
Time spent below target (TBR)
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.