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Not yet recruitingNCT07920341Updated Nov 5, 2026

Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes

An interventional study of FreeStyle Libre 3 Plus Continuous Glucose Monitor in Continuous Glucose Monitoring, Type 1 Diabetes and Type 2 Diabetes, sponsored by University of the Pacific. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by University of the Pacific · Not applicable, Interventional, and Other

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Continuous Glucose Monitoring
  • Type 1 Diabetes
  • Type 2 Diabetes

Keywords

  • Continuous Glucose Monitoring
  • CGM
  • Inter-Arm Differences
  • Glucose
  • Hypoglycemia
  • Type 2 Diabetes
  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,619 studies on the registry are indexed under Diabetes Mellitus, Type 1; 587 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 2,721 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of the Pacific is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Device: FreeStyle Libre 3 Plus Continuous Glucose Monitor

Interventions

  • DeviceFreeStyle Libre 3 Plus Continuous Glucose Monitor

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 days

Secondary outcomes

  1. 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.

    Time frame: 14 days

  2. 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.

    Time frame: 14 days

  3. 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.

    Time frame: 14 days

  4. 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.

    Time frame: 14 days

  5. 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.

    Time frame: 14 days

07

Study locations

1 site
  • University of the Pacific
    Stockton, California 95211, United States
    • Innovative Clinical and Outcomes Research (iCOR) · Contacticor@pacific.edu · 9252555374
    • Sachin A Shah, PharmD · Principal investigator
    • Allen Shek, PharmD · Sub investigator
    • Aydin Shek · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with others.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 822 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 12 months is below that.

Counting every sponsor, half of 922 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 5, 2026
StartEst.
Nov 4, 2026
Primary completionEst.
Nov 4, 2027
CompletionEst.
Nov 4, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920341
Lead sponsor
University of the Pacific
Responsible party
Sachin Shah (Sachin Shah, PharmD, FACC, FAHA, University of the Pacific) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 4, 2026 (estimated)
Primary completion
Nov 4, 2027 (estimated)
Completion
Nov 4, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Innovative Clinical and Outcomes Research (iCOR)
Contact
icor@pacific.edu
925-255-5374

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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