- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01954459
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hypotheses:
- Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
- The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
- Age 8 years to less than 45 years old.
- Subject understands the study protocol and agree to comply with it.
- Subject is on insulin pump or injection-based basal-bolus therapy
- Subject comprehends written English.
- For females, subject not intending to become pregnant during the study.
- Informed Consent Form signed by the subject
- No history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear.
- Hemoglobin A1C ≤10%
Exclusion Criteria:
- 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:
a. Current use of systemic corticosteroids (within the last week) b. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. 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 or past use of a continuous glucose sensor is not an exclusion criterion.
- Active skin condition that would affect sensor placement
- Use of acetaminophen or Vitamin C supplement within the last 7 days
- Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
Pregnancy A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Sensor alone
Glucose sensor site will not have Insupatch
|
Glucose sensor inserted without warming patch
|
|
Eksperimentel: Sensor with Insupatch
Glucose sensor site with Insupatch
|
Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use.
Tidsramme: 4 hours after lunch, 8 hours after breakfast
|
Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use, comparing sensor glucose readings and signal data to serum Yellow Springs Instrument (YSI) glucose measurements, with each subject acting as his or her own control.
|
4 hours after lunch, 8 hours after breakfast
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Camille Michaud, MD, Yale University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1306012208
- R01DK085618-01 (U.S. NIH-bevilling/kontrakt)
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 .
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