RECRUITING

The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus LabPatch Continuous Glucose Monitoring (CGM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes

Quick Facts

Study Start:2023-02-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05754281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Subject is between 18 and 75 years of age. 3. 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. 4. 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).	1. Subject is pregnant or lactating. 2. Subject is not treated with insulin. 3. Subject has/had acute or chronic, contagious, infectious disease 4. Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV) 5. Subject has/had clotting or bleeding disorders or other hematological disease. 6. Subject has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix). 7. Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Subject is between 18 and 75 years of age.
3. 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.
4. 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).

1. Subject is pregnant or lactating.
2. Subject is not treated with insulin.
3. Subject has/had acute or chronic, contagious, infectious disease
4. Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV)
5. Subject has/had clotting or bleeding disorders or other hematological disease.
6. Subject has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
7. Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.

Contacts and Locations

Study Locations (Sites)

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Joslin Diabetes Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-02-03

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

LabPatch Continuous Glucose Monitoring (CGM)

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus