Cascade CGM 15-day Performance Assessment

Continuous Glucose Monitoring Clinical Trial

— CASPA  

Official title:

Cascade Continuous Glucose Monitor 15-day Performance Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099043
• Other study ID #: PR-19-0032
• Status: Completed
• Phase: N/A
• Start date: September 28, 2019
• Est. completion date: October 13, 2019

Study information

• Verified date: September 2019
• Source: WaveForm Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To validate the feasibility of a 15-day wear period of the Cascade CGM system

Description:

To assess a 15-day wear period for the Cascade CGM. This study includes ten subjects who will interface with the system and take finger stick BGM glucose values for calibration. The wear period includes four in-clinic days frequent blood draws and eleven at home days at a single testing site.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Continuous Glucose Monitoring

Intervention

Device:
• Cascade Continuous Glucose Monitoring System
Continuous Glucose Monitoring for 15 days

Locations

Country	Name	City	State
Slovenia	Splošna bolnišnica Celje	Celje

Sponsors (1)

Lead Sponsor	Collaborator
WaveForm Technologies Inc.

Country where clinical trial is conducted

Slovenia, 

Outcome

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