Clinical trial NCT04099043: Cascade CGM 15-day Performance Assessment
Official title: Cascade Continuous Glucose Monitor 15-day Performance Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Glucose Monitoring
Lead sponsor: WaveForm Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 15-day Continuous Glucose Monitoring
timeFrame: Fifteen days
Secondary outcomes:
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: Splošna bolnišnica Celje
Study officials:
affiliation: Splošna bolnišnica Celje
name: Maja Navodnik Peložnik, MD
role: PRINCIPAL_INVESTIGATOR
References: