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Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

18. april 2020 oppdatert av: Marc Breton, University of Virginia

Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

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

  • Forente stater
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 and over
  • Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
  • Willing to wear a CGM at least 70% of the time while in the study
  • Willing to wear an Apple watch on their dominant hand while awake
  • Missing or late in giving at least four food boluses in the previous 2 weeks
  • Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  • Current treatment for a seizure disorder
  • Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Klue App Use then Usual Care
Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.
Annen: Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
Eksperimentell: Usual Care then Klue App Use
Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.
Annen: Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of missed meal boluses
Tidsramme: During the two weeks prior to each visit
The change in the number of missed meal boluses
During the two weeks prior to each visit

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of missed meal boluses as a measure of attenuation to the alerts
Tidsramme: 6 weeks
The change in the number of missed meal boluses as a measure of attenuation to the alerts
6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts
Tidsramme: 12 weeks
The change in the number of missed meal boluses as a measure of attenuation to the alerts
12 weeks
Change in Hemoglobin A1c Levels
Tidsramme: 3 months
Change in Hemoglobin A1c Levels
3 months
Time in range 70-180 mg/dL
Tidsramme: 6 weeks
Time in range 70-180 mg/dL as measured by CGM
6 weeks
Time in range 70-180 mg/dL
Tidsramme: 12 weeks
Time in range 70-180 mg/dL as measured by CGM
12 weeks
Percent time <70 mg/dL mean glucose
Tidsramme: 6 weeks
Percent time <70 mg/dL mean glucose as measured by CGM
6 weeks
Percent time <70 mg/dL mean glucose
Tidsramme: 12 weeks
Percent time <70 mg/dL mean glucose as measured by CGM
12 weeks
Glucose Coefficient of Variation
Tidsramme: 6 weeks
Glucose (as measured by CGM) Coefficient of Variation
6 weeks
Glucose Coefficient of Variation
Tidsramme: 12 weeks
Glucose (as measured by CGM) Coefficient of Variation
12 weeks
Total daily insulin dose
Tidsramme: 6 weeks
Total daily insulin dose
6 weeks
Total daily insulin dose
Tidsramme: 12 weeks
Total daily insulin dose
12 weeks
Number of meal bolus injections each day
Tidsramme: 6 weeks
Number of meal bolus injections each day
6 weeks
Number of meal bolus injections each day
Tidsramme: 12 weeks
Number of meal bolus injections each day
12 weeks
Number of total bolus injections each day
Tidsramme: 6 weeks
Number of total bolus injections each day
6 weeks
Number of total bolus injections each day
Tidsramme: 12 weeks
Number of total bolus injections each day
12 weeks
Total daily basal insulin
Tidsramme: 6 weeks
Total daily basal insulin
6 weeks
Total daily basal insulin
Tidsramme: 12 weeks
Total daily basal insulin
12 weeks
Accuracy of Klue in detecting meals
Tidsramme: 3 months
Accuracy of Klue in detecting meals (true positive and false positive rates)
3 months
User satisfaction of Klue
Tidsramme: 3 months
User satisfaction of Klue
3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores
Tidsramme: 3 months
DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
3 months
Diabetes Distress Scale (DDS) Scores
Tidsramme: 3 months
DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Virginia

Samarbeidspartnere

Stanford University
Klue, Inc.

Etterforskere

  • Hovedetterforsker: Marc Breton, PhD, University of Virginia

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.

Generelle publikasjoner

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)

29. mai 2019

Primær fullføring (Faktiske)

18. november 2019

Studiet fullført (Faktiske)

18. november 2019

Datoer for studieregistrering

Først innsendt

11. januar 2019

Først innsendt som oppfylte QC-kriteriene

15. januar 2019

Først lagt ut (Faktiske)

18. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 180034

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is no current plan to share individual participant data

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på Diabetes mellitus, type 1

Kliniske studier på Klue App

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