Continuous Glucose Monitoring Clinical Trial
— CASPAOfficial title:
Cascade Continuous Glucose Monitor 15-day Performance Assessment
Verified date | September 2019 |
Source | WaveForm Technologies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To validate the feasibility of a 15-day wear period of the Cascade CGM system
Status | Completed |
Enrollment | 10 |
Est. completion date | October 13, 2019 |
Est. primary completion date | October 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - • Signed informed consent form - Diagnosis of type 1 or type 2 (on insulin therapy) diabetes mellitus for at least 6 months - 18 years of age or older - Currently self-monitoring capillary blood glucose (on average at least three times per day or more) or on a CGM for at least three months - Willing to have blood glucose levels manipulated into high and low glucose levels during in clinic days if deemed appropriate per the protocol based on insulin use. - Willing to follow all study procedures, including attending all clinic visits during which a venous line will be inserted for blood sampling, wearing CGM sensors for entire study, performing fingertip glucose tests for self-monitoring and calibration, and keeping a diary of activities. - Be willing to wear two investigational CGM devices. Exclusion Criteria: - • Known allergy to medical grade adhesives - Magnetic Resonance Imaging (MRI) scheduled during CGM sensor wear period - Persons with type 2 diabetes using diet and exercise only for diabetes management - Used an investigational drug within 30 days prior to study entry - Hematocrit < 32% (obtained during screening) - Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal - Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g., percutaneous transluminal coronary angioplasty [PTCA], stent placement), or coronary artery bypass graft (CABG) within the past six months - Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis - Cerebrovascular incident within the past six month - History or presence of eczema, psoriasis, atopic or contact dermatitis - Subject is pregnant at the start of the study. - Current use or within one-week exposure to topical medications at the proposed insertion sites - Seizure disorder (epilepsy) - Malignancy within the past five years, except basal cell or squamous cell skin cancers - Major surgical operation within 30 days prior to screening - Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity (reason for exclusion will be clearly documented by investigator or designee) |
Country | Name | City | State |
---|---|---|---|
Slovenia | Splošna bolnišnica Celje | Celje |
Lead Sponsor | Collaborator |
---|---|
WaveForm Technologies Inc. |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 15-day Continuous Glucose Monitoring | Fifteen days of sensor wear with the Cascade CGM Smart Device App | Fifteen days |
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