- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01954459
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
-
-
Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University School of Medicine
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Sensor alone
Glucose sensor site will not have Insupatch
|
Glucose sensor inserted without warming patch
|
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Experimentell: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Camille Michaud, MD, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1306012208
- R01DK085618-01 (U.S.S. NIH-anslag/kontrakt)
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