Glucomen Day Cascade CGM System 21-Day Wear Study

Study Overview
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Brief Summary
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Assessment of 21-day CGM wear period

Detailed Description
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This single-site study will include 10 subjects who will wear two CGMs for 21 days. On day 1, 5, 10, 15, and 21 subjects will be in-clinic for 12 hrs of testing with YSI blood glucose measurements taken every 15 minutes.

Official Title
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GlucoMen Day Cascade CGM 21-Day Study

Conditions
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Efficacy of a 21-Day Wear Period for the Cascade CGM

Intervention / Treatment
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* Device: Cascade CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 Be 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. Sign informed consent form 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 months History or presence of eczema, psoriasis, atopic or contact dermatitis Pregnancy 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GLUCODAY21<br>Study subjects for 21-day study | Device: Cascade CGM<br>* 21-days of CGM wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 21-Day CGM Functionality The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days. | To evaluate the feasibility of a 21-day wear CGM system. The secondary objective is: -To evaluate the uniformity of the performance of the WaveForm GlucoMmen Day Cascade CGM over 21 days. To evaluate the feasibility of a 21-day wear CGM system. | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Uniformity | To evaluate the uniformity of the performance of the WaveForm GlucoMen Day Cascade CGM over 21 days. | From 15 to 21 days |