A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

NCT02646878 | Withdrawn FDA Device

• 1 other identifier: CEP310
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Type 2 Diabetes; Harmony Sensor; Continuous Glucose Monitoring; CGM

Outcome Measures

Primary Outcomes (1)

• 24 hour calibration requirement

  Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements

  10 days

Study Arms (2)

Harmony 1 Sensor Group A

OTHER

Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion.

Device: Harmony 1 Sensor

Harmony 1 Sensor Group B

OTHER

Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion.

Device: Harmony 1 Sensor

Interventions

Harmony 1 Sensor DEVICE

Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.

Harmony 1 Sensor Group A; Harmony 1 Sensor Group B

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 14 - 75 years of age at time of screening
• A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Adequate venous access as assessed by investigator or appropriate staff

You may not qualify if:

• Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual.
• Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
• Subject is female and has a positive pregnancy screening test
• Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
• Subject is female and plans to become pregnant during the course of the study
• Subject has had a hypoglycemic seizure within the past 6 months
• Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit.
• Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
• Subject has a history of a seizure disorder
• Subject has central nervous system or cardiac disorder resulting in syncope
• Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• Subject has a hematocrit (Hct) lower than the normal reference range
• Subject has a history of adrenal insufficiency.

Sponsors & Collaborators

• Medtronic Diabetes: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ronald Brazg, MD

  Rainer Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Mark Christiansen, MD

  Diablo Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share