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

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Harmony 1 Sensor

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Type 2 Diabetes, Harmony 1

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Group A

Arm Description

Subjects wearing Harmony 1 Sensor for up to 10 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02456922

First Posted

May 12, 2015

Last Updated

September 28, 2020

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT02456922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Withdrawn

Why Stopped

For administraive reasons

Study Start Date

July 2018 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Type 2 Diabetes

Keywords

Type 1 Diabetes, Type 2 Diabetes, Harmony 1

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Other

Arm Description

Subjects wearing Harmony 1 Sensor for up to 10 days.

Intervention Type

Device

Intervention Name(s)

Harmony 1 Sensor

Intervention Description

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.

Primary Outcome Measure Information:

Title

Harmony 1 Sensor accuracy

Description

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: