Type 1 Diabetes MellitusNCT05754281
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- 2nd Gen LabPatch Glucose Sensing System
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 31 Dec 2027
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with type 1 or type 2 diabetes treated with insulin.
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Subject is between 18 and 75 years of age.
- Subject is diagnosed with type 1 diabetes or type 2 diabetes for ≥3 months and is being treated with insulin injections in the form of multiple daily injections or through insulin infusion pump.
- Subject is a male or a non-pregnant and non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- Subject is pregnant or lactating.
- Subject is not treated with insulin.
- Subject has/had acute or chronic, contagious, infectious disease
- Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV)
- Subject has/had clotting or bleeding disorders or other hematological disease.
- Subject has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
- Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The primary endpoint of this study is the mean absolute relative difference (MARD) for 2nd Gen LabPatch system compared to each of the above mentioned glucose references over a 6 hour outpatient visit.
Read the detailed description
In a pilot study conducted previously by our group using the prototype 1st generation LabPatch system (PRECISION study, 2016-31), the investigators found that LabPatch glucose measurements strongly correlated with those of YSI, OneTouch Verio, and Freestyle lite in a sample of 30 subjects. However, the investigators observed significant inter- and intra-subject variability of LabPatch glucose measurements. Factors that may have contributed to this variability include: manual manufacturing of the 1st Gen LabPatch circuit chips and/or variability in the pressure applied by subjects on the circuit chip at each measurement. To control for these variables with the goal of improving overall accuracy, Cambridge Medical Technologies, LLC significantly improved and completely automated the manufacturing process of the circuit chips. In addition, the system has been miniaturized to a more user-friendly layout and with a clasp unit to control for pressure applied by the subject finger on the circuit chip.
The 2nd Gen LabPatch system consists of:
- The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements The system has been previously tested on 10 human subjects with type 1 diabetes, each for six hours, at the Georgetown University Medical Center under clinical conditions supervised by a medical team including an endocrinologist and dermatologist. The test confirmed the absence of pain or abnormal physical sensation and that the operation of the device causes no tissue damage,instigates no neural sensation for the subject, and leaves no blemish on the skin. No skin damage incurred by the LabPatch operation was detected.
The 2nd Gen LabPatch system is an in vitro diagnostic device (IVD), does not have significant risk and is therefore exempted from the IDE requirements. In addition, the device uses an in vitro diagnostic technology that does not create adverse events and therefore a data safety monitoring board (DSMB) is not requited.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- 2nd Gen LabPatch Glucose Sensing System
- Keywords
- LabPatch Continuous Glucose Monitoring (CGM)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2nd Gen LabPatch Glucose Sensing SystemDevice
- The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact
II. A LabPatch clasp device
III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | 60 adult subjects with type 1 or type 2 diabetes treated with insulin. The accuracy of the 2nd Gen LabPatch Continuous Glucose Sensing will be evaluated during the study visit, comparing to YSI 2300 STAT Plus, OneTouch Verio and FreeStyle Lite. Receives: Device: 2nd Gen LabPatch Glucose Sensing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute relative difference (MARD)
Blood glucose values (mg/dL) from the LabPatch system and reference YSI, One Touch Verio, and FreeStyle Lite will be used to report the mean absolute relative difference (MARD) in Percentage (%).
Measured: Baseline, every 15 minutes for a total of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start3 Feb 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Medical Technologies, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754281
- Sponsor's protocol ID
- STUDY00000130
- Status last verified
- May 2026
- First submitted
- 22 Feb 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
- ClinicalTrials.gov ID
- NCT05754281
- Acronym / sponsor ID
- STUDY00000130
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Keywords
- LabPatch Continuous Glucose Monitoring (CGM)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Cambridge Medical Technologies, LLC
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2023 (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.
The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The primary endpoint of this study is the mean absolute relative difference (MARD) for 2nd Gen LabPatch system compared to each of the above mentioned glucose references over a 6 hour outpatient visit.
Detailed description
In a pilot study conducted previously by our group using the prototype 1st generation LabPatch system (PRECISION study, 2016-31), the investigators found that LabPatch glucose measurements strongly correlated with those of YSI, OneTouch Verio, and Freestyle lite in a sample of 30 subjects. However, the investigators observed significant inter- and intra-subject variability of LabPatch glucose measurements. Factors that may have contributed to this variability include: manual manufacturing of the 1st Gen LabPatch circuit chips and/or variability in the pressure applied by subjects on the circuit chip at each measurement. To control for these variables with the goal of improving overall accuracy, Cambridge Medical Technologies, LLC significantly improved and completely automated the manufacturing process of the circuit chips. In addition, the system has been miniaturized to a more user-friendly layout and with a clasp unit to control for pressure applied by the subject finger on the circuit chip.
The 2nd Gen LabPatch system consists of:
- The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements The system has been previously tested on 10 human subjects with type 1 diabetes, each for six hours, at the Georgetown University Medical Center under clinical conditions supervised by a medical team including an endocrinologist and dermatologist. The test confirmed the absence of pain or abnormal physical sensation and that the operation of the device causes no tissue damage,instigates no neural sensation for the subject, and leaves no blemish on the skin. No skin damage incurred by the LabPatch operation was detected.
The 2nd Gen LabPatch system is an in vitro diagnostic device (IVD), does not have significant risk and is therefore exempted from the IDE requirements. In addition, the device uses an in vitro diagnostic technology that does not create adverse events and therefore a data safety monitoring board (DSMB) is not requited.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: 2nd Gen LabPatch Glucose Sensing System60 adult subjects with type 1 or type 2 diabetes treated with insulin. The accuracy of the 2nd Gen LabPatch Continuous Glucose Sensing will be evaluated during the study visit, comparing to YSI 2300 STAT Plus, OneTouch Verio and FreeStyle Lite. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with type 1 or type 2 diabetes treated with insulin.
Key inclusion criteria (4 listed)
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Subject is between 18 and 75 years of age.
- Subject is diagnosed with type 1 diabetes or type 2 diabetes for ≥3 months and is being treated with insulin injections in the form of multiple daily injections or through insulin infusion pump.
- Subject is a male or a non-pregnant and non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Key exclusion criteria (7 listed)
- Subject is pregnant or lactating.
- Subject is not treated with insulin.
- Subject has/had acute or chronic, contagious, infectious disease
- Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV)
- Subject has/had clotting or bleeding disorders or other hematological disease.
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 |
|---|---|---|
| 2nd Gen LabPatch Glucose Sensing SystemI. The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements | Device | Study Cohort |
Primary outcome
Mean absolute relative difference (MARD)
Time frame: Baseline, every 15 minutes for a total of 6 hours
Blood glucose values (mg/dL) from the LabPatch system and reference YSI, One Touch Verio, and FreeStyle Lite will be used to report the mean absolute relative difference (MARD) in Percentage (%).
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 29 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Joslin Diabetes Center 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute relative difference (MARD) (time frame: Baseline, every 15 minutes for a total of 6 hours). 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 29 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.