Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
29. januar 2018 opdateret af: Bruce A. Buckingham, Stanford University
Development of Algorithms for a Hypoglycemic Prevention Alarm
This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.
The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
After the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night).
Three predictive algorithm versions were studied sequentially during the study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
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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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Barbara Davis Center for Childhood Diabetes, University of Colorado
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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
12 år til 46 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18 years or older,
- Type 1 diabetes for at least 1 year
- Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose sensor
- Hemoglobin A1c level of < 8.0%,
- Home computer with access to the Internet,
- At least one CGMglucose value < 70 mg/dL during the most recent 15 nights of CGM glucose data.
- Not pregnant or planning to become pregnant
Exclusion Criteria:
The exclusion criteria for this study is the following:
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Angina (recurrent heart pain)
- Past heart attack or coronary artery (heart vessel) disease
- Past stroke or impairment of blood flow to the brain
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Predictive Low Glucose Suspend
The pump suspension system consists of the Revel CGM device communicating with a laptop computer that contains the hypoglycemia prediction algorithm.
During the 21 night study period, the laptop is placed at the bedside and turned on by the participant at bedtime and off on arising in the morning.The laptop contains a randomization schedule (2:1) that indicats whether the hypoglycemia prediction algorithm will be in operation that night (Predictive Low Glucose Suspend Algorithm ON) or will not be activated (Predictive Low Glucose Suspend Algorithm OFF), to which the participant is blinded.
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The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.
Andre navne:
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL
Tidsramme: 21 days
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Nights with CGM sensor values < 60 mg/dL were considered to be undesirable.
A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed.
Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
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21 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Nights With CGM Values >180 mg/dL
Tidsramme: 21 days
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Nights with CGM sensor values >180 mg/dL were considered to be undesirable.
Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
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21 days
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Mean Morning Blood Glucose (BG)
Tidsramme: 21 days
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Desirable glucose level was 70-180 mg/mL.
Average of all morning BG data is presented.
Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
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21 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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.
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
1. maj 2007
Primær færdiggørelse (Faktiske)
1. juli 2011
Studieafslutning (Faktiske)
1. august 2011
Datoer for studieregistrering
Først indsendt
17. april 2009
Først indsendt, der opfyldte QC-kriterier
20. april 2009
Først opslået (Skøn)
21. april 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SU-10162008-1321
- Stanford eprotocol # 6789 (Anden identifikator: Stanford University)
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 .