Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22903
- University of Virginia Center for Diabetes Technology
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes,
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel.
All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system).
Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission.
Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Sperimentale: Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission.
Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission.
As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent of Sensor Glucose Readings Between 70-180 mg/dL
Lasso di tempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent of Time Sensor Glucose Readings Are <70 mg/dL
Lasso di tempo: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
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Percent of Time Sensor Glucose Readings Are >150 mg/dL
Lasso di tempo: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
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Percent of Time Sensor Glucose Readings Are >180 mg/dL
Lasso di tempo: 68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
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Percent of Time Sensor Glucose Readings Are >250 mg/dL
Lasso di tempo: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
|
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Percent of Time Sensor Glucose Readings Are >400 mg/dL
Lasso di tempo: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Lasso di tempo: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
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Distribution of Sensor and Meter Glucose Values (Maximum)
Lasso di tempo: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
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Distribution of Sensor and Meter Glucose Values (Minimum)
Lasso di tempo: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Lasso di tempo: 72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
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Mean BG (as Measured by CGM)
Lasso di tempo: 68 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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Hypoglycemia Area Under the Curve <60
Lasso di tempo: 72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
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Hypoglycemia Area Under the Curve <70 mg/dL
Lasso di tempo: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Hyperglycemia Area Under the Curve >180
Lasso di tempo: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
|
Hyperglycemia Area Under the Curve >250 mg/dL
Lasso di tempo: 72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
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Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Lasso di tempo: 68 hours
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All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
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68 hours
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End of Night Blood Glucose
Lasso di tempo: 72 hours
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All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
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72 hours
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 18888
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