Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment

Continuous Glucose Monitoring Clinical Trial

— CUSP  

Official title:

Cascade CGM 15-Day US Performance Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04397965
• Other study ID #: EXT-1040
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: WaveForm Technologies Inc.
• Contact: Mihailo V. Rebec, PhD
• Phone: 503-855-5377
• Email: mrebec[@]agamatrix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System

Description:

To assess a 15-day wear period for the Cascade CGM. The study wear period includes four in-clinic days in which frequent blood draws and Yellow Springs Instrument (YSI) glucose measurements will be performed. Participants will be blinded to CGM glucose values during the study. A retrospective performance assessment will be conducted following the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 using a CGM for at least three months -Willing to follow all study procedures, including attending all clinic visits (including in- clinic sessions during which a venous line will be inserted for blood sampling), wearing a CGM sensor(s) for fifteen days, performing fingertip glucose tests for self-monitoring, and keeping a diary of activities.

• Be willing to wear 2 investigational CGM devices.

Exclusion Criteria:

1. Known allergy to medical grade adhesives

2. Magnetic Resonance Imaging (MRI) scheduled during fifteen-day CGM sensor wear period

3. Persons with type 2 diabetes using diet and exercise only for diabetes management

4. Used an investigational drug within 30 days prior to study entry

5. Hematocrit < 35% for females and <40% for males (obtained during screening)

6. Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal

7. 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

8. Diagnosis of the following diabetic autonomic neuropathies: orthostatic hypotension, heart rate anomalies, gastroparesis

9. Cerebrovascular incident within the past six months

10. History or presence of eczema, psoriasis, atopic or contact dermatitis

11. Subject must not be pregnant at the start of the study.

12. Current use or within one-week exposure to topical medications at the proposed insertion sites

13. Seizure disorder (epilepsy)

14. Malignancy within the past five years, except basal cell or squamous cell skin cancers

15. Major surgical operation within 30 days prior to screening

16. 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)

17. Subject has experienced severe hypoglycemia or severe hyperglycemia in the last six months. Severe hypoglycemia is defined as having low blood glucose levels that requires assistance from another person to treat. Severe hypoglycemia is classed as a diabetic emergency. Severe hyperglycemia is defined as a blood ketone level >1.6 millimolar (mM).

Related Conditions & MeSH terms

• Continuous Glucose Monitoring

Intervention

Device:
• Cascade Continuous Glucose Monitor
Continuous Glucose Monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
WaveForm Technologies Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Use	Validate the feasibility of a 15-day wear period of the Cascade CGM. The primary endpoint is an 80% sensor survival rate over a 15-day wear period, which includes four in-clinic days and eleven at-home days.	15 days
Secondary	Performance	Accuracy performance compared to YSI readings. The secondary endpoints are: to achieve <15% Mean Average Relative Difference (MARD) and <20mg/dL Mean Average Difference (MAD) compared to YSI readings during the four in-clinic days and to assess Blood Glucose Meter (BGM) fingerstick calibration success.	15 days