Type 1 Diabetes MellitusNCT03966911

Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

A study testing Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter in people with Type 1 Diabetes Mellitus and Type2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days). Read more about this study

Who is it for?: Ages 2 to 80 years
Conditions the study is for: Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
What is being tested?: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 335 participants
Where: 15 sitesUnited States
Study dates: 14 Jun 2019to 13 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Individual is 2 - 80 years of age at time of enrollment
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
Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only

Who cannot join

Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
Subject has any unresolved adverse skin condition in the area of 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
Female of child bearing age and who is sexually active should be excluded if she is 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 15Show fewer

Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment
Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
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 (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents)
Subject has a history of adrenal insufficiency
Subject is a member of the research staff involved with the study.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Barbara Davis Center - Adults
Aurora, Colorado, 80045
Barbara Davis Center for Childhood Diabetes (Pediatric)
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78749
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133
University of Virgina
Charlottesville, Virginia, 22903
IDERC
Des Moines, Iowa, 50265
AMCR Institue
Escondido, California, 92026
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Rainer Clinical Research Center
Renton, Washington, 98057
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
University of South Florida
Tampa, Florida, 33613
SoCal Diabetes
Torrance, California, 90505
Diablo Clinical Research
Walnut Creek, California, 92025
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Read the detailed description

The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Conditions: Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
Being tested: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guardian™ Sensor (3) connected to a Guardian™ Connect TransmitterDevice
Continuous Glucose Monitoring and frequent sample testing

Study groups in NCT03966911
Study group	Role	What they receive
Subjects with diabetes wearing Guardian™ Sensor (3)	Other	Subjects wear Guardian™ Sensor (3) and Guardian™ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data. Receives: Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Readings Within 20% Agreement
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
Measured: 7 days (170 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201913 May 2020

First posted29 May 2019
Study start14 Jun 2019
Primary completion13 May 2020
Study completion13 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 Diabetes MellitusStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03966911
Sponsor's protocol ID: CIP324
Status last verified: May 2021
First submitted: 23 May 2019
Last updated: 7 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
ClinicalTrials.gov ID: NCT03966911
Acronym / sponsor ID: CIP324
Conditions: Type 1 Diabetes Mellitus, Type2 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 14 Jun 2019 (actual)
Primary completion: 13 May 2020 (actual)
Study completion: 13 May 2020 (actual)
First posted: 29 May 2019 (actual)
Results: Posted 7 Jun 2021

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 Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subjects with diabetes wearing Guardian™ Sensor (3)	Other	Device: Guardian™ Sensor (3) connected to a Guardian™ Connect TransmitterSubjects wear Guardian™ Sensor (3) and Guardian™ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.

Who may qualify

Ages: 2 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Individual is 2 - 80 years of age at time of enrollment
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
Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only

Key exclusion criteria (15 listed)

Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
Subject has any unresolved adverse skin condition in the area of 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
Female of child bearing age and who is sexually active should be excluded if she is 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
Guardian™ Sensor (3) connected to a Guardian™ Connect TransmitterContinuous Glucose Monitoring and frequent sample testing	Device	Subjects with diabetes wearing Guardian™ Sensor (3)

Primary outcome

Percentage of Readings Within 20% Agreement
Time frame: 7 days (170 hours)
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.

Results and safety

Results posted to the registry on 7 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)	169	160
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)	142	126

Primary outcome: Percentage of Readings Within 20% Agreement

Time frame: 7 days (170 hours). Mean (91.8% Confidence Interval). Unit: Percentage of Readings

Measure	Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm n = 169	Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen n = 169	Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm n = 142	Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Buttock n = 142
Value	88.00 (86.05 to 89.95)	87.96 (86.13 to 89.80)	84.59 (82.02 to 87.17)	81.05 (77.58 to 84.53)

Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Arm: Intercept from ANCOVA as agreement rate: 88.00 (91.8% CI 86.05 to 89.95), p <0.041, ANCOVA
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3) on the Abdomen: Intercept from ANCOVA as agreement rate: 87.96 (91.8% CI 86.13 to 89.80), p <0.041, ANCOVA
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3) on the Arm: Intercept from ANCOVA as agreement rate: 84.59 (91.8% CI 82.02 to 87.17), p = 0.041, ANCOVA

Population analysed: Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear

Adverse events

Time frame: Throughout the course of the study, up to 91 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Subjects (Age 18-80) With Diabetes Wearing Guardian™ Sensor (3)	2 of 169 (1.2%)	37 of 169 (21.9%)	0 of 169
Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardian™ Sensor (3)	2 of 142 (1.4%)	32 of 142 (22.5%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 15 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: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Readings Within 20% Agreement (time frame: 7 days (170 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03966911.

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 7 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.