A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

Type 2 Diabetes Clinical Trial

Official title:

A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02456922
• Other study ID #: CEP301
• Status: Withdrawn
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• Harmony 1 Sensor
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harmony 1 Sensor accuracy	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