Continuous Glucose MonitoringNCT07920341
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
A study testing FreeStyle Libre 3 Plus Continuous Glucose Monitor in people with Continuous Glucose Monitoring and Type 1 Diabetes, run by University of the Pacific at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring, Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- FreeStyle Libre 3 Plus Continuous Glucose Monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2026to 4 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of the Pacific
Stockton, California, 95211
Innovative Clinical and Outcomes Research (iCOR), 9252555374, icor@pacific.edu
Sachin A Shah, PharmD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- FreeStyle Libre 3 Plus Continuous Glucose Monitor
- Keywords
- Continuous Glucose Monitoring, CGM, Inter-Arm Differences, Glucose, Hypoglycemia, Type 2 Diabetes, Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 3 Plus Continuous Glucose MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Left and Right Arm CGM Wear | Experimental | 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. Receives: Device: FreeStyle Libre 3 Plus Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm.
Measured: 14 days
Secondary outcomes (5)
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
Difference in the frequency of Level 1 hypoglycemic events (54 to <70 mg/dL) between the left arm and right arm.
Measured: 14 days
Difference in Frequency of Level 2 Hypoglycemic Events Between Left and Right Arms
Difference in the frequency of Level 2 hypoglycemic events (<54 mg/dL) between the left arm and right arm.
Measured: 14 days
Difference in Percentage of Time Below Range (<70 mg/dL) Between Left and Right Arms
Difference in percentage of time below range (TBR) <70 mg/dL between the left and right arms.
Measured: 14 days
Difference in Percentage of Time Below Range (54 to <70 mg/dL) Between Left and Right Arms
Difference in percentage of time below range (TBR) from 54 to <70 mg/dL (Level 1 hypoglycemia) between the left and right arms.
Measured: 14 days
Difference in Percentage of Time Below Range (<54 mg/dL) Between Left and Right Arms
Difference in percentage of time below range (TBR) <54 mg/dL (Level 2 hypoglycemia) between the left and right arms.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion4 Nov 2027 (estimated)
- Study completion4 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sachin Shah, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920341
- Sponsor's protocol ID
- IRB2026-284
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared with others.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inter-Arm Differences in Continuous Glucose Monitor Glucose Readings in Patients With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07920341
- Acronym / sponsor ID
- IRB2026-284
- Keywords
- Continuous Glucose Monitoring, CGM, Inter-Arm Differences, Glucose, Hypoglycemia, Type 2 Diabetes, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 4 Nov 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left and Right Arm CGM Wear | Experimental | Device: FreeStyle Libre 3 Plus Continuous Glucose MonitorParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre 3 Plus Continuous Glucose MonitorTwo 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. | Device | Left and Right Arm CGM Wear |
Primary outcome
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
Time frame: 14 days
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm.
5 secondary outcomes
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
Time frame: 14 days
Difference in Frequency of Level 2 Hypoglycemic Events Between Left and Right Arms
Time frame: 14 days
Difference in Percentage of Time Below Range (<70 mg/dL) Between Left and Right Arms
Time frame: 14 days
Difference in Percentage of Time Below Range (54 to <70 mg/dL) Between Left and Right Arms
Time frame: 14 days
Difference in Percentage of Time Below Range (<54 mg/dL) Between Left and Right Arms
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 3 Plus Continuous Glucose Monitor in people with Continuous Glucose Monitoring and Type 1 Diabetes, run by University of the Pacific at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Innovative Clinical and Outcomes Research (iCOR) (925-255-5374, icor@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.