- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04531111
Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt
Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt: A Pilot Study
During the current unusual situation with COVID-19 pandemic and the lockdown applied in most of the countries, school students were kept at home and offered e-learning modules and all activities were suspended.
Lockdown entails significant modifications of life style, involving changes in physical activities, dietary habits and nutrition, which are likely to impact glycemic control.
So the aim of the current study is to evaluate the impact of COVID-19 pandemic on glycemic control among children and adolescents with type 1 diabetes.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
All aspects of life were significantly impacted by the COVID-19 pandemic. The pandemic created heavy burdens on all countries affecting all foundations of the country. Global measures aimed to limit spread of COVID- 19 infection and a series of restriction were announced by serial countries including the suspension of schools, organized sports activities and gatherings. On March, 2020 Egypt started to take a series of lockdown regulation to control the spread of infection.
The restriction and lockdown will impact the whole population especially populations with chronic disease. It is known that the lockdown will render access to outpatient clinics and services,beside the possible limitation of access to care, the restrictions may affect glycemic control patients with diabetes.
The negative impact of limiting physical exercise, behavioral changes, dietary changes and fear of shortage of medical supplies could have an influence on diabetes control.
Study procedure:
All included patients / caregivers will complete an online questionnaire. For patients with limited internet access, the questionnaire will be carried out through phone calls according to patients' convenience.
Perceived stress scale-10 (Arabic Validated version) will be used to measure patients'/ caregivers' level of stress in response to the extraordinary status of the pandemic and its consequences. The scale is a 10 questions scale that will be circulated among the patients as an Arabic validated electronic form .
Medical reports and files of included patients will be reviewed and last visit before the lock down will be thoroughly evaluated to identify:
- Patients' body weight, body mass index.
- Insulin regimen with special emphasis on total daily dose and percentage of basal insulin.
- Glycemic control of patients by evaluating the last HbA1C After completing the questionnaire, patients' insulin dosage and glycemic control during the quarantine period will be re-evaluated.
Evaluation of glycemic control at the end of the study:
- For patients on self- monitoring of blood glucose, a rapid Hba1c test will be done according to patients' convenience, patterns and frequency of hypoglycemia and hyperglycemia will be evaluated.
- For those on continous glucose monitoring ( if available), the data will be extracted from the ambulatory glucose profile(AGP).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Yasmine Elhenawy
- Numero di telefono: +201006714334
- Email: dr_yasmi@yahoo.com
Backup dei contatti dello studio
- Nome: Khadiga Eltonbary
Luoghi di studio
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Cairo, Egitto, 11765
- Reclutamento
- Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
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Contatto:
- Yasmine Ehenawyl
- Numero di telefono: +201006714334
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Contatto:
- Khadiga Eltonbary
- Numero di telefono: +201010477244
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with type 1 diabetes and willing to participate in the study.
- Age: less than 18 years old
Exclusion Criteria:
- Newly diagnosed patients with type 1 diabetes and those in honeymoon period.
- Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes.
- Patients with any other chronic disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes
Lasso di tempo: 12 weeks
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Change in HbA1c from baseline to 3 month after the lockdown
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12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes
Lasso di tempo: 12 weeks
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Change in total insulin dosage from baseline to 3 month after the lockdown
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12 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yasmine Elhenawy, ain shams University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Malattie autoimmuni
- Polmonite, virale
- Polmonite
- Malattie polmonari
- Malattie del sistema endocrino
- COVID-19
- Diabete mellito
- Diabete mellito, tipo 1
Altri numeri di identificazione dello studio
- FMASU P66/2020
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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-
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