CompletedNot Applicable

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

France77 participantsStarted 2021-01-15

Plain-language 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. 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.

Who can participate

Age range

13 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown

Timeframe: 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

Timeframe: 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

Timeframe: Measure repeated 2 times : month before lockdown (28 days), second month of lockdown (28 days)

Trial details

NCT IDNCT04669912

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-22

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