Real-time Reminders To Decrease Late or Missed Meal Boluses (Klue)
31. august 2021 opdateret af: Bruce Buckingham, Stanford University
Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes.
The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion.
It will send text alerts to the user asking if they have bolused.
This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit.
If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.
Studieoversigt
Detaljeret beskrivelse
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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone.
Missing or late meal boluses will be assessed through their pump/pen and sensor downloads.
This is a pilot study.
The investigators do not have 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Palo Alto, California, Forenede Stater, 94305
- Stanford
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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
13 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 13 and over
- On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Using an iPhone
- 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 two weeks
- Understanding and willingness to follow the protocol and sign informed consent
- Ability to speak, read and write in the language of the investigators
Exclusion Criteria:
- Pregnant or lactating
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.
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 |
|---|---|
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Ingen indgriben: Standard Care
Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory
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Eksperimentel: Klue
Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.
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Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in the number of missed meal boluses
Tidsramme: The two weeks prior to each study visit
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A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.
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The two weeks prior to each study visit
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in time in range
Tidsramme: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject
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sensor glucose values between 70-180 mg/dl
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data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject
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Positive predictive value of a Klue meal alert
Tidsramme: All data for the 6 weeks on the Klue intervention arm when Klue is active
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Percent of time a meal alert signaled a meal
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All data for the 6 weeks on the Klue intervention arm when Klue is active
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.
- Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.
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)
12. oktober 2018
Primær færdiggørelse (Faktiske)
19. marts 2020
Studieafslutning (Faktiske)
30. marts 2020
Datoer for studieregistrering
Først indsendt
23. august 2018
Først indsendt, der opfyldte QC-kriterier
30. maj 2019
Først opslået (Faktiske)
3. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 47137
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