- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456922
A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
September 28, 2020 updated by: Medtronic Diabetes
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This study is a multi-center, randomized, prospective single-sample correlational design without controls.
A total of up to 310 previously-diagnosed type 1 or 2 diabetes subjects will be enrolled in order to have 160 subjects complete frequent sample testing at up to 17 centers.
Subjects will wear Harmony 1 sensors used with the Guardian Mobile application.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is 2-75 years of age at time of screening
- A clinical diagnosis of type 1 or 2 diabetes for a minimum of 12 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
- Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.
Exclusion Criteria:
- Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individuals
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group A
Subjects wearing Harmony 1 Sensor for up to 10 days.
|
Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harmony 1 Sensor accuracy
Time Frame: 10 days
|
Sensor accuracy will be evaluated compared to YSI plasma glucose values during frequent sample testing.
A within 30% mean agreement rate (±22.5 mg/dL when Reference BG ≤ 75 mg/dL) between sensor and YSI will be evaluated against the null Hypothesis for varying glucose ranges.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Brazg, MD, Rainier Clinical Research Center
- Principal Investigator: Robert Slover, MD, Barbara Davis Center
- Principal Investigator: Kevin Kaiserman, MD, SoCal Diabetes
- Principal Investigator: Luis Casaubon, MD, Texas Diabetes & Endocrinology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
May 12, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (Estimate)
May 29, 2015
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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