NCT05754281Active, not recruiting
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- 3 Feb 2023
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Joslin Diabetes Center
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05754281
What you commit to
- Study type: Observational
- Planned participants: 60
- From 3 Feb 2023 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject is not treated with insulin.
- Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.
Other illness
- 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).
Other
- Subject is pregnant or lactating.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.