- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02848261
Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
7. november 2019 oppdatert av: Korey Hood, Stanford University
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
92
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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California
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Stanford, California, Forente stater, 94305
- Stanford University
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado
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Florida
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Tampa, Florida, Forente stater, 33620
- University of South Florida
-
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University
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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
2 år til 6 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
To be eligible for the study, a child must meet the following criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- Time since diagnosis of at least six months
- Age between 2 and 6 years at enrollment
- Parental consent to participate in the study
- No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
- If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
- Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod
To be eligible for the study, a parent must meet the following criteria:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- Age of 18.0 years or older
- Parent comprehends written English
- Parent understands the study protocol and signs the informed consent document
- Parent has access to a personal computer to upload diabetes devices and send to research team
The presence of any of the following is an exclusion for the study:
- Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of study
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: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Nødreduksjon
Identifiser og reduser foreldrenes plagesymptomer og bekymringer.
Gi strategier for å få sosial støtte.
|
Utdanning og opplæring for å redusere nød
|
Eksperimentell: Developmental Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
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Education and training related to use of CGM in this age group
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Eksperimentell: Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
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Education and training on the use of remote monitoring
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Eksperimentell: Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
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Education and training on reducing fear of hypoglycemia
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Placebo komparator: No Intervention
Serves as the control group comparator.
No intervention provided.
|
No intervention - serves as the control group
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time spent in blood glucose range
Tidsramme: Change over 6 months
|
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome.
This measure will be used as a primary outcome and derived from objective data downloads.
|
Change over 6 months
|
Pediatric Quality of Life Inventory
Tidsramme: Change over 6 months
|
This is a measure of health-related quality of life.
It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
|
Change over 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
A1c
Tidsramme: Change over 6 months
|
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes.
Collected through a blood sample.
|
Change over 6 months
|
Problem Areas in Diabetes
Tidsramme: Change over 6 months
|
This measure captures areas that are reported as problems for people with diabetes.
Participants in the study report on daily problems with diabetes via this measure.
|
Change over 6 months
|
Diabetes Distress Scale
Tidsramme: Change over 6 months
|
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
|
Change over 6 months
|
Patient Health Questionnaire 9
Tidsramme: Change over 6 months
|
This is a widely used measure that captures depressive symptoms.
It is reported by the participants.
|
Change over 6 months
|
State-Trait Anxiety Inventory
Tidsramme: Change over 6 months
|
This is a widely used measure of anxiety symptoms.
It is reported by the participant.
|
Change over 6 months
|
Pittsburgh Sleep Quality Index
Tidsramme: Change over 6 months
|
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
|
Change over 6 months
|
Hypoglycemic Fear Survey
Tidsramme: Change over 6 months
|
People with diabetes worry about hypoglycemia.
This measure captures those worries and is reported by participants.
|
Change over 6 months
|
Hypoglycemic Confidence Questionnaire
Tidsramme: Change over 6 months
|
Hypoglycemia needs to be managed in various daily situations.
This questionnaire captures confidence of the participants in those various situations.
|
Change over 6 months
|
Glucose Monitoring System Satisfaction Survey
Tidsramme: Change over 6 months
|
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
|
Change over 6 months
|
General and diabetes-specific technology use
Tidsramme: Change over 6 months
|
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
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Change over 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Linda DiMeglio, MD, Indiana University
- Hovedetterforsker: Kimberly Driscoll, PhD, University of Colorado, Denver
- Hovedetterforsker: Henry Rodriguez, MD, University of South Florida
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 (Faktiske)
15. august 2016
Primær fullføring (Faktiske)
1. april 2019
Studiet fullført (Faktiske)
1. april 2019
Datoer for studieregistrering
Først innsendt
25. juli 2016
Først innsendt som oppfylte QC-kriteriene
25. juli 2016
Først lagt ut (Anslag)
28. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. november 2019
Sist bekreftet
1. november 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 37360
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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