Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

7. november 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

92

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado
    • Florida
      • Tampa, Florida, Forenede Stater, 33620
        • University of South Florida
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

To be eligible for the study, a child must meet the following criteria:

  1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
  2. Time since diagnosis of at least six months
  3. Age between 2 and 6 years at enrollment
  4. Parental consent to participate in the study
  5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
  6. If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
  7. 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:

  1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
  2. Age of 18.0 years or older
  3. Parent comprehends written English
  4. Parent understands the study protocol and signs the informed consent document
  5. 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:

  1. 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).
  2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
  3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  4. Child is unable to completely avoid acetaminophen for duration of study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nødreduktion
Identificer og reducer forældrenes nødsymptomer og bekymringer. Giv strategier til at opnå social støtte.
Adfærdsmæssigt: Nødreduktion
Uddannelse og træning i at reducere nød
Eksperimentel: 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.
Adfærdsmæssigt: Developmental Demands
Education and training related to use of CGM in this age group
Eksperimentel: Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
Adfærdsmæssigt: Remote Monitoring
Education and training on the use of remote monitoring
Eksperimentel: Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
Adfærdsmæssigt: Fear of Hypoglycemia
Education and training on reducing fear of hypoglycemia
Placebo komparator: No Intervention
Serves as the control group comparator. No intervention provided.
Adfærdsmæssigt: No intervention
No intervention - serves as the control group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.
Change over 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Samarbejdspartnere

University of Colorado, Denver
University of South Florida
Indiana University

Efterforskere

  • Ledende efterforsker: Linda DiMeglio, MD, Indiana University
  • Ledende efterforsker: Kimberly Driscoll, PhD, University of Colorado, Denver
  • Ledende efterforsker: Henry Rodriguez, MD, University of South Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. august 2016

Primær færdiggørelse (Faktiske)

1. april 2019

Studieafslutning (Faktiske)

1. april 2019

Datoer for studieregistrering

Først indsendt

25. juli 2016

Først indsendt, der opfyldte QC-kriterier

25. juli 2016

Først opslået (Skøn)

28. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 37360

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes mellitus

Kliniske forsøg med Nødreduktion

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Albania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner