Type 1 DiabetesNCT02646878
A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
A study testing Harmony 1 Sensor in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc..
Trial summary
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Harmony 1 Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
Read the detailed description
The study is a multi-center, prospective single-sample correlational design without controls.
- Conditions
- Type 1 Diabetes
- Being tested
- Harmony 1 Sensor
- Keywords
- Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmony 1 SensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Harmony 1 Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour calibration requirement
Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016 (estimated)
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Brazg, MD, Principal investigator, Rainer Clinical Research CenterMark Christiansen, MD, Principal investigator, Diablo Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646878
- Sponsor's protocol ID
- CEP310
- Status last verified
- Nov 2017
- First submitted
- 22 Dec 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
- ClinicalTrials.gov ID
- NCT02646878
- Acronym / sponsor ID
- CEP310
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (estimated)
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
Detailed description
The study is a multi-center, prospective single-sample correlational design without controls.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmony 1 Sensor Group A | Other | Device: Harmony 1 SensorSubjects 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. |
| Harmony 1 Sensor Group B | Other | Device: Harmony 1 SensorSubjects 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. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmony 1 SensorUse 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. | Device | Harmony 1 Sensor Group A, Harmony 1 Sensor Group B |
Primary outcome
24 hour calibration requirement
Time frame: 10 days
Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Brazg, MD principal investigator
Rainer Clinical Research Center
Mark Christiansen, MD principal investigator
Diablo Clinical Research
Questions about this trial
What is this clinical trial studying?
A study testing Harmony 1 Sensor in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour calibration requirement (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.