Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
A Prospective, Single Arm, Open-label, Interventional Study to Evaluate the Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With Type 1 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how accurate and consistent the CareSens Air 3 continuous glucose monitor is at measuring blood sugar. It is for adults ages 18–65 with type 1 diabetes who use daily insulin shots or an insulin pump.
This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–65 years old.
- You have type 1 diabetes and have used multiple daily insulin shots or an insulin pump for at least 3 months. Pumps that automatically adjust insulin using a glucose monitor are allowed.
- You choose to join and sign a consent form.
Who can't join
- You have certain skin problems where the sensor would go, such as severe skin disease, burns, scars, a large tattoo, or a staph infection. You have an allergy to medical adhesives or a history of frequent pockets of infection at insulin pump sites.
- In the past 3 months, low blood sugar caused you to pass out or have a seizure needing emergency care, or you had diabetic ketoacidosis (dangerous acid buildup from diabetes). You cannot sense low blood sugar, have a condition that makes it more likely, or have an HbA1c above 9.5% (a measure of average blood sugar).
- You have a history of epilepsy or fainting within the past 6 months. You have unstable or poorly treated heart or blood vessel disease, including stroke, mini-stroke, poor blood flow, or serious heart rhythm problems. You have anemia (low hemoglobin in your blood).
- You have a pacemaker or a similar medical device, or you plan to have an X-ray, MRI, CT scan, or diathermy (a deep-heating treatment) during the study.
- You are pregnant, breastfeeding, planning pregnancy, or do not agree to use adequate birth control during the study.
- You are in another study, were in one within 2 weeks before screening, or plan to join one that the study doctor believes could affect safety or results. You depend on the study sponsor or study doctor.
- You will not limit the foods listed in Appendix 3 to the allowed amounts, or you cannot or will not follow study procedures.
- You have problems with thinking or memory, or the study doctor believes the study is not suitable for you or could put you at greater risk.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Adults who are 18-65 years of age, inclusive * Patients with type 1 diabetes who use intensive insulin therapy (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) including users of systems with continuous glucose monitoring (CGM) driven automatic adjustment of insulin doses for at least 3 months * Patients who voluntarily decide to participate in the study and provide written informed consent Exclusion Criteria: * The following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection. * Allergic contact dermatitis to medical adhesives. * History of frequent catheter abscesses associated with pump therapy. * Severe hypoglycemia events within 3 months prior to screening. Severe hypoglycemia is defined as loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia. * Hypoglycemia unawareness. * Conditions that predispose to hypoglycemia including inadequately treated thyroid and adrenal disease. * Participants with diabetic ketoacidosis within 3 months prior to screening. * History of epilepsy or syncope within 6 months prior to screening. * Unstable vascular diseases (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including: Stroke, transitory cerebral ischemia, ischemic heart disease, peripheral vascular disease, and serious arrhythmia. * Patients with anemia (hemoglobin below normal range). * Patients scheduled for X-ray, MRI, CT or diathermy during the study. * Pregnant or lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study. * Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study participant or the study result. * Patients unwilling to abstain from ingesting the foodstuffs listed in Appendix 3 in excess of the allowed amounts. * Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator. * Wearing of a pace maker or other comparable medical devices. * HbA1c \>9.5%. * Dependency from the sponsor or the clinical investigator. * Unwillingness and/or inability to comply with study procedures.
Study sites (4)
CA
- Headlands Research AMCR · Escondido, CA 92025Site Director · Study contact · 760-466-1523 · Laura.Bedolla@Headlandsresearchamcr.comMore trials in Escondido
- Diablo Clinical Research · Walnut Creek, CA 94598Principal Investigator, MD · Study contact · 925-930-7267 · Mchristiansen@flourishresearch.comMore trials in Walnut Creek
GA
- Atlanta Diabetes Associates · Atlanta, GA 30318Amanda Maxson Clinical Research Manager, RN · Study contact · 404-355-4393More trials in Atlanta
WA
- Rainier Clinical Reseach Center · Renton, WA 98057Principal Investigator, MD · Study contact · 425-251-1720 · SMarks@rainier-research.comMore trials in Renton