Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Evaluation of Inter-Arm Differences in Continuous Glucose Monitor Glucose Readings in Patients With Type 1 and Type 2 Diabetes
This is a clinical trial looking at differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes. The study will enroll 60 participants who will wear a CGM sensor on both arms for 14 days.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This study is a prospective, non-randomized clinical trial designed to evaluate differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes.
The study will enroll 60 participants. Each participant will wear two FreeStyle Libre 3 Plus CGM sensors simultaneously for 14 days, with one sensor placed on each arm.
The primary objective is to compare the frequency of hypoglycemic events, defined as glucose readings below 70 mg/dL, between the left and right arms. Secondary analyses will evaluate differences in Level 1 and Level 2 hypoglycemia and time below range. Additional analyses will compare time in range, time above range, time below range, and average glucose between the two arms.
CGM data from the two sensors will be collected and compared to evaluate differences in glucose readings between the left and right arms.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Innovative Clinical and Outcomes Research (iCOR)
- Telefoonnummer: 925-255-5374
- E-mail: icor@pacific.edu
Studie Locaties
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California
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Stockton, California, Verenigde Staten, 95211
- University of the Pacific
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Contact:
- Innovative Clinical and Outcomes Research (iCOR)
- Telefoonnummer: 9252555374
- E-mail: icor@pacific.edu
-
Hoofdonderzoeker:
- Sachin A Shah, PharmD
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Onderonderzoeker:
- Allen Shek, PharmD
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Onderonderzoeker:
- Aydin Shek
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Adults 18 years of age and over
- Diagnosed with type 1 or 2 diabetes mellitus
- Female participants with childbearing potential must have a negative urine pregnancy stick test, which has been confirmed by investigators
- Willingness to wear a CGM on each arm for 2 weeks
- A1c <7% within the past 6 months
- Willing to attend 3 virtual call meetings over the course of the trial
- Have active health insurance throughout the duration of the study
- Willing to refrain from consuming or using commercial products containing ascorbic acid (vitamin C) or salicylic acid, and certain skincare products for the duration of the study due to their known potential to interfere with CGM readings (exposure via food is allowed)
- Participants must have a mobile phone that is connected to the internet and compatible with both "FreeStyle Libre 3" and "Libre by Abbott" apps
Exclusion Criteria:
- Under the age of 18
- Any active dermatologic condition on the upper arms
- Implanted medical devices (e.g., pacemaker, insulin pump)
- Use of any medical or other devices (e.g., TMS) incompatible with the FreeStyle Libre 3 Plus CGM
- Critically ill or dialysis patients
- Planned high-frequency electrical heat treatment (diathermy) during the study period
- Currently taking hydroxyurea
- History of or planned gastric bypass within the study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
- Refusal to sign the informed consent document or HIPAA authorization form
- Pregnant, planned pregnancy during study period, or currently breastfeeding
- History of allergic reactions or hypersensitivity to adhesives
- Blood transfusion within the previous 3 months
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Left and Right Arm CGM Wear
Participants will wear two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) simultaneously for 14 days, with one sensor applied to the back of the upper arm on each arm. Participants will continue their normal daily routine during the study period. CGM data from the left and right arms will be compared. |
Two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) will be worn simultaneously for 14 days. One sensor will be applied subcutaneously to the back of the upper arm on each arm. The sensors measure glucose in the interstitial fluid, and data from the left and right arms will be collected and compared. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm. |
14 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in the frequency of Level 1 hypoglycemic events (54 to <70 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Frequency of Level 2 Hypoglycemic Events Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in the frequency of Level 2 hypoglycemic events (<54 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Percentage of Time Below Range (<70 mg/dL) Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in percentage of time below range (TBR) <70 mg/dL between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (54 to <70 mg/dL) Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in percentage of time below range (TBR) from 54 to <70 mg/dL (Level 1 hypoglycemia) between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (<54 mg/dL) Between Left and Right Arms
Tijdsspanne: 14 days
|
Difference in percentage of time below range (TBR) <54 mg/dL (Level 2 hypoglycemia) between the left and right arms. |
14 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB2026-284
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared with others.
Informatie over medicijnen en apparaten, studiedocumenten
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