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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

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
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Virginia

Samarbejdspartnere

Stanford University
Klue, Inc.

Efterforskere

  • Ledende efterforsker: Marc Breton, PhD, University of Virginia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

29. maj 2019

Primær færdiggørelse (Faktiske)

18. november 2019

Studieafslutning (Faktiske)

18. november 2019

Datoer for studieregistrering

Først indsendt

11. januar 2019

Først indsendt, der opfyldte QC-kriterier

15. januar 2019

Først opslået (Faktiske)

18. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 180034

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is no current plan to share individual participant data

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Diabetes mellitus, type 1

Kliniske forsøg med Klue App

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Djibouti

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner