Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
22. juni 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- University of Virginia Center for Diabetes Technology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
5 år til 9 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent of Sensor Glucose Readings Between 70-180 mg/dL
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Tidsramme: 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
Tidsramme: 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
Tidsramme: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
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Percent of Time Sensor Glucose Readings Are >250 mg/dL
Tidsramme: 68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
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Percent of Time Sensor Glucose Readings Are >400 mg/dL
Tidsramme: 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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Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Tidsramme: 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 (Maximum)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
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Hypoglycemia Area Under the Curve <60
Tidsramme: 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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Hypoglycemia Area Under the Curve <70 mg/dL
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2016
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. mai 2016
Datoer for studieregistrering
Først innsendt
15. april 2016
Først innsendt som oppfylte QC-kriteriene
20. april 2016
Først lagt ut (Anslag)
25. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18888
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Not yet determined
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