Type 1 Diabetes MellitusNCT04436822

Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

A study testing Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 18 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) 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, Type 2 Diabetes Mellitus
What is being tested?: Continuous Glucose Monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 317 participants
Where: 18 sitesin 2 countries
Study dates: 15 Jul 2020to 12 Apr 2022
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.
Subject has a clinical diagnosis of type 1 or type 2 diabetes:
If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
If subject is participating in YSI™* FST , subject has 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 factor(s). Subjects without ratios may participate under observation only.

Who cannot join

Subject will not tolerate tape adhesive in the area of sensor 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 (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
Subject is a sexually active female of child-bearing potential and 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
If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of 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

18 sites in 2 countries.

Country

City, postcode or hospital

18 sites in 2 countries

United States13 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Texas Diabetes & Endocrinology
Austin, Texas, 78749
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
AMCR Institute
Escondido, California, 92025
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
University of South Florida
Tampa, Florida, 33612
SoCal Diabetes
Torrance, California, 90505
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598

Other trials in United States

China5 sites

Dalian Municiple Central Hospital
Dalian, Liaoning, 116089
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310005
Nanjing First Hospital
Nanjing, Jiangsu, 210008
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Read the detailed description

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

This is a multi-center study.

Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Being tested: Continuous Glucose Monitoring
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.

Continuous Glucose MonitoringDevice
CGM and frequent sample testing

Study groups in NCT04436822
Study group	Role	What they receive
Subjects with diabetes wearing DS5	Experimental	Subjects wearing DS5 over 7 days and participating in FSTs. Receives: Device: Continuous Glucose Monitoring

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 [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
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.

15 Jul 202012 Apr 2022

First posted18 Jun 2020
Study start15 Jul 2020
Primary completion12 Apr 2022
Study completion12 Apr 2022

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: 317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04436822
Sponsor's protocol ID: CIP330
Status last verified: May 2023
First submitted: 12 Jun 2020
Last updated: 2 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
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

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
ClinicalTrials.gov ID: NCT04436822
Acronym / sponsor ID: CIP330
Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 317 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jul 2020 (actual)
Primary completion: 12 Apr 2022 (actual)
Study completion: 12 Apr 2022 (actual)
First posted: 18 Jun 2020 (actual)
Results: Posted 2 Jun 2023

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 Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Detailed description

The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

This is a multi-center study.

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 DS5	Experimental	Device: Continuous Glucose MonitoringSubjects wearing DS5 over 7 days and participating in FSTs.

Who may qualify

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

Key inclusion criteria (6 listed)

Individual is 2 - 80 years of age at time of enrollment.
Subject has a clinical diagnosis of type 1 or type 2 diabetes:
If subject is participating in YSI™* FST , subject has 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 factor(s). Subjects without ratios may participate under observation only.

Key exclusion criteria (15 listed)

Subject will not tolerate tape adhesive in the area of sensor 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 (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
Subject is a sexually active female of child-bearing potential and 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
Continuous Glucose MonitoringCGM and frequent sample testing	Device	Subjects with diabetes wearing DS5

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 [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.

Results and safety

Results posted to the registry on 2 Jun 2023, 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) Wearing DS5	172	160
Pediatric Subjects (Age 2-17) Wearing DS5	138	132

Primary outcome: Percentage of Readings Within 20% Agreement

Time frame: 7 days (170 hours). Mean (90% Confidence Interval). Unit: percentage of readings

Measure	Adult Subjects (Age 18-80) Wearing DS5 on the Arm n = 155	Pediatric Subjects (Age 2-17) Wearing DS5 on the Arm n = 127	Pediatric Subjects (Age 2-17) Wearing DS5 on the Buttock n = 118
Value	88.9 (87.1 to 90.7)	87.5 (85.4 to 89.7)	87.9 (85.8 to 89.9)

Adult Subjects (Age 18-80) Wearing DS5 on the Arm: Intercept from ANCOVA as agreement rate: 88.9 (90% CI 87.1 to 90.7), p <0.05, ANCOVA
Pediatric Subjects (Age 2-17) Wearing DS5 on the Arm: Intercept from ANCOVA as agreement rate: 87.5 (90% CI 85.4 to 89.7), p <0.05, ANCOVA
Pediatric Subjects (Age 2-17) Wearing DS5 on the Buttock: Intercept from ANCOVA as agreement rate: 87.9 (90% CI 85.8 to 89.9), p <0.05, 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 approximately 90 days (including an up to 7-day training period and a 7-day study period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Subjects (Age 18-80) Wearing DS5	1 of 172 (0.6%)	27 of 172 (15.7%)	0 of 172
Pediatric Subjects (Age 2-17) Wearing DS5	0 of 138 (0%)	23 of 138 (16.7%)	0 of 138

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes Mellitus

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

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.

18 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 18 sites in 2 countries.

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 6 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, China. 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 2 Jun 2023). 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 NCT04436822.

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 2 Jun 2023.