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Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

22. června 2017 aktualizováno: Mark DeBoer, MD, University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.

Typ studie

Intervenční

Zápis (Aktuální)

12

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Virginia
      • Charlottesville, Virginia, Spojené státy, 22903
        • University of Virginia Center for Diabetes Technology

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

5 let až 9 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: Diabetes Assistant (DiAs) with Closed-Loop
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.
Experimentální: 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.
Přístroj: Diabetes Assistant (DiAs) with Closed-Loop
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Časové okno: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Časové okno: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >150 mg/dL
Časové okno: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Percent of Time Sensor Glucose Readings Are >180 mg/dL
Časové okno: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >250 mg/dL
Časové okno: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >400 mg/dL
Časové okno: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Časové okno: 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
Distribution of Sensor and Meter Glucose Values (Maximum)
Časové okno: 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
Distribution of Sensor and Meter Glucose Values (Minimum)
Časové okno: 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
Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Časové okno: 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
Mean BG (as Measured by CGM)
Časové okno: 68 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.
68 hours
Hypoglycemia Area Under the Curve <60
Časové okno: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hypoglycemia Area Under the Curve <70 mg/dL
Časové okno: 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 >180
Časové okno: 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
Časové okno: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Časové okno: 68 hours
All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
68 hours
End of Night Blood Glucose
Časové okno: 72 hours
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.
72 hours

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Virginia

Spolupracovníci

DexCom, Inc.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2016

Primární dokončení (Aktuální)

1. května 2016

Dokončení studie (Aktuální)

1. května 2016

Termíny zápisu do studia

První předloženo

15. dubna 2016

První předloženo, které splnilo kritéria kontroly kvality

20. dubna 2016

První zveřejněno (Odhad)

25. dubna 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. července 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. června 2017

Naposledy ověřeno

1. června 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 18888

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Not yet determined

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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