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Lo studio clinico NCT02530450 per Diabete mellito di tipo 1 è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Continuous Glucose Monitor in Children With Poorly Controlled Diabetes 30
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La sperimentazione clinica NCT02530450 è stata uno studio osservazionale per Diabete mellito di tipo 1, attualmente completato. Avviato il 1 maggio 2011, prevedeva di arruolare 30 partecipanti. Sotto la guida di The University of Texas Health Science Center at San Antonio, si è concluso il 1 marzo 2013. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 6 ottobre 2017.
Sommario breve
The purpose of this study is to determine if the use of continuous glucose monitoring in a practical outpatient clinic setting in children with poorly controlled diabetes will lead to improved blood sugar control.
Descrizione dettagliata
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the Univer...Mostra di più
Titolo ufficiale
iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study
Patologie
Diabete mellito di tipo 1Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- HSC20110049H
Numero NCT
Data di inizio (effettiva)
2011-05
Ultimo aggiornamento pubblicato
2017-10-06
Data di completamento (stimata)
2013-03
Arruolamento (previsto)
30
Tipo di studio
Osservazionale
Stato
Completato
Parole chiave
children
poor adherence
continuous glucose monitoring
poor adherence
continuous glucose monitoring
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Group 1 Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use | continuous glucose monitoring (CGM) All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points. |
Group 2 Never blinded to continuous glucose monitoring (CGM) data | continuous glucose monitoring (CGM) All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
The Primary Outcome Measure Was Change in HgbA1c | 0 months, 3 months and 6 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia | 3 months and 6 months |
Criteri di eleggibilità
Età idonea
Bambino
Età minima
7 Years
Sessi idonei
Tutti
- Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
- Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
- HgbA1c >8.5% (equivalent to average BG of >205 mg/dL for past three months).
- Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
- Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
- Attend proposed clinic, nutritional, and CGM follow up visits.
- Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
- Hypoglycemic unawareness.
- English or Spanish primary language.
- Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
- Documented concomitant chronic disease known to affect glycemic control.
- 3 or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
- 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
- Reported alcohol or drug abuse.
- Documented cutaneous allergy to latex products.
- Documented eating disorders or morbid obesity as assessed by the investigator.
- Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- Home use of CGM in the past 6 months.
The University of Texas Health Science Center at San AntonioMedtronic DiabetesNessun dato di contatto
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