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

22 czerwca 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

12

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Virginia
      • Charlottesville, Virginia, Stany Zjednoczone, 22903
        • University of Virginia Center for Diabetes Technology

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

5 lat do 9 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Eksperymentalny: 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.
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Ramy czasowe: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Virginia

Współpracownicy

DexCom, Inc.

Śledczy

  • Główny śledczy: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2016

Zakończenie podstawowe (Rzeczywisty)

1 maja 2016

Ukończenie studiów (Rzeczywisty)

1 maja 2016

Daty rejestracji na studia

Pierwszy przesłany

15 kwietnia 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 kwietnia 2016

Pierwszy wysłany (Oszacować)

25 kwietnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 lipca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 czerwca 2017

Ostatnia weryfikacja

1 czerwca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 18888

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Not yet determined

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