Type 1 DiabetesCOVIDIABADONCT04669912
COVID-19 Pandemic Lockdown Effect in Adolescents and Young Adults With Type 1 Diabetes: Positive Results of an Unpreceded Challenge for Telemedicine and Patient Self-management
An observational study of Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 22 Jan 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population will be selected from two university general hospitals of the region of Ile de France (France): Kremlin-Bicetre hospital and Sud-Francilien hospital. The population will be aged from to 13 to 25 years at the beginning of lockdown.
Who may be able to join
- Type 1 diabetes
- Age between 13 and 25 years
- use of a flash glucose monitoring related to the LibreView cloud platform
- patients follow-up by the diabetes department of Hopital Sud Francilien or the diabetes department of Hôpital Bicêtre.
- patient informed of the study and not having objected to it.
Who cannot join
- patients out of France during lockdown
- other type of diabetes
- Duration of diabetes of less than one year
- patient aged under 13 years or above 26 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.
The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.
The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.
Read the detailed description
Continuous glucose monitoring (CGM) data will be collected from the cloud-based platform, LibreView.
Data will be collected for patients from Sud-Francilien hospital (Corbeil-Essonnes, France) and Kremlin-Bicêtre hospital (Kremlin-Bicêtre, France). Data related to glucose control and sensor usage will be collected from the Libreview platform. Data related to patients' characteristics, treatment and telemedicine visits (number of contacts with health professionals) will be collected from the medical record and confirmed with telephone-administered questionnaire.
The lockdown imposed by the French government occurred from March 17 to May 10, 2020. Therefore, outcomes will be assessed 4 times: the month before lockdown, during the first month, the second month of lockdown, and one month after lockdown ended.
Potential confounding factors will be studied: age, gender, type of insulin delivery (multiple daily injections, MDI; insulin pump), contacts with health professionals (physician or nurse).
Descriptive statistics will include means with standard deviations, numbers of patients and percentages.
Outcomes will be analysed with a linear mixed-effects regression model. Analyses will be performed with R studio version 3.5.0.
- Conditions
- Type 1 Diabetes
- Being tested
- glucose control and sensor usage
- Keywords
- type 1 diabetes, adolescent, COVID-19, telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 1, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose control and sensor usageOther
Data related to glucose control and sensor usage collected from the Libreview platform
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 2 times : month before lockdown (28 days), after lockdown
Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)
Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)
Secondary outcomes (8)
Evolution of glucose management indicator (GMI) compared to before lockdown.
Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using continuous glucose monitoring data collected on Libreview.
Measured: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range <54 mg/dL
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 54 - 70 mg/dL
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 180-250 mg/dL
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range > 250 mg/dL
Percentage of time spent in this glucose range in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of average glucose in mg/dL compared to before lockdown.
Average glucose level in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of hypoglycaemia frequency compared to before lockdown.
Number of hypoglycaemia events (glycemia under 70 mg/dL during at least 15 minutes) in a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Measured: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose sensor use compared to before lockdown.
The level of glucose data collected related to the glucose monitoring frequency and the number of scans with continuous glucose monitoring data collected on Libreview.
Measured: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2021
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred PENFORNIS, MD PhD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669912
- Sponsor's protocol ID
- 2020-A02760-39
- Acronym
- COVIDIABADO
- Status last verified
- May 2026
- First submitted
- 7 Dec 2020
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.
- ClinicalTrials.gov ID
- NCT04669912
- Acronym / sponsor ID
- COVIDIABADO / 2020-A02760-39
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, adolescent, COVID-19, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 17 Dec 2020 (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.
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.
The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.
The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.
Detailed description
Continuous glucose monitoring (CGM) data will be collected from the cloud-based platform, LibreView.
Data will be collected for patients from Sud-Francilien hospital (Corbeil-Essonnes, France) and Kremlin-Bicêtre hospital (Kremlin-Bicêtre, France). Data related to glucose control and sensor usage will be collected from the Libreview platform. Data related to patients' characteristics, treatment and telemedicine visits (number of contacts with health professionals) will be collected from the medical record and confirmed with telephone-administered questionnaire.
The lockdown imposed by the French government occurred from March 17 to May 10, 2020. Therefore, outcomes will be assessed 4 times: the month before lockdown, during the first month, the second month of lockdown, and one month after lockdown ended.
Potential confounding factors will be studied: age, gender, type of insulin delivery (multiple daily injections, MDI; insulin pump), contacts with health professionals (physician or nurse).
Descriptive statistics will include means with standard deviations, numbers of patients and percentages.
Outcomes will be analysed with a linear mixed-effects regression model. Analyses will be performed with R studio version 3.5.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population will be selected from two university general hospitals of the region of Ile de France (France): Kremlin-Bicetre hospital and Sud-Francilien hospital. The population will be aged from to 13 to 25 years at the beginning of lockdown.
Key inclusion criteria (5 listed)
- Type 1 diabetes
- Age between 13 and 25 years
- use of a flash glucose monitoring related to the LibreView cloud platform
- patients follow-up by the diabetes department of Hopital Sud Francilien or the diabetes department of Hôpital Bicêtre.
- patient informed of the study and not having objected to it.
Key exclusion criteria (4 listed)
- patients out of France during lockdown
- other type of diabetes
- Duration of diabetes of less than one year
- patient aged under 13 years or above 26 years old
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 |
|---|---|---|
| glucose control and sensor usageData related to glucose control and sensor usage collected from the Libreview platform | Other | – |
Primary outcome
Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown
Time frame: Measure repeated 2 times : month before lockdown (28 days), after lockdown
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown
Time frame: Measure repeated 2 times : month before lockdown (28 days), first month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown
Time frame: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)
Percentage of time spent in glucose range from 70 to 180 mg/dL over a month (28 days) according to continuous glucose monitoring data collected on Libreview.
8 secondary outcomes
Evolution of glucose management indicator (GMI) compared to before lockdown.
Time frame: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range <54 mg/dL
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 54 - 70 mg/dL
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range 180-250 mg/dL
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose time spent below range > 250 mg/dL
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of average glucose in mg/dL compared to before lockdown.
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of hypoglycaemia frequency compared to before lockdown.
Time frame: Measure repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
Evolution of glucose sensor use compared to before lockdown.
Time frame: Measures repeated 4 times (including 28 days of data for each): month before lockdown (28 days), first month of lockdown (28 days), second month of lockdown (28 days), first month after lockdown (28 days).
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 22 May 2026.
- 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.
Alfred PENFORNIS, MD PhD principal investigator
Centre Hospitalier Sud Francilien
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 Type 1 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 5 inclusion and 4 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 22 May 2026. 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?
Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown (time frame: Measure repeated 2 times : month before lockdown (28 days), after lockdown). The study lists 3 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 22 May 2026.