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New treatment option for Type 1 Diabetes Mellitus
Official title Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
ClinicalTrials.gov ID: NCT07296276
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)...
- Patients who voluntarily decide to participate in the study and provide written informed consent
You likely can't join if
- The following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site: Severe psoriasis, recent burn injury...
- 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...
- Hypoglycemia unawareness.
- Conditions that predispose to hypoglycemia including inadequately treated thyroid and adrenal disease.
See the full eligibility 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)...
- Patients who voluntarily decide to participate in the study and provide written informed consent
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Walnut Creek, California, United States
- Atlanta, Georgia, United States
- Renton, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Walnut Creek, California, United States; Atlanta, Georgia, United States; Renton, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.