Type 1 Diabetes MellitusNCT04809285
Use of the Guardian™ Connect System With Smart Connected Devices
A study testing Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with… Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 14 sitesUnited States
- Study dates
- 6 Apr 2021to 29 Sep 2023
- 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 consent.
- A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for:
- at least the last 6 months for subjects 2-6 years of age
- at least the last 12 months for subjects 7-80 years of age
- Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and pen cartridge(s).
- Subject is currently using or is willing to use the Guardian Connect system during the study.
- Subject agrees to comply with the study protocol requirements.
- For adult subjects: Subject is capable of providing legal consent without a legal authorized representative.
Who cannot join
- Subject is using a syringe and unwilling or unable to use insulin pen(s).
- Subject is using an insulin pump.
- Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study.
- Subject is using hydroxyurea at time of screening or plans to use it during the study.
- Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider.
- Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
Show all 11Show fewer
- Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
- Subject has a positive urine pregnancy test at time of screening.
- Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study.
- Subject is unwilling to participate in study procedures.
- Subject is directly involved in the study as research staff.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045-2536
Texas Diabetes and Endocrinology
Austin, Texas, 78731
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Arkansas Diabetes and Endocrinology Center
Little Rock, Arkansas, 72211
Loma Linda University Medical Center
Loma Linda, California, 92354-3811
Mary and Dick Allen Diabetes Center
Newport Beach, California, 92663
Rhode Island Hospital (Lifespan Clinical Research Center)
Providence, Rhode Island, 02903
Rainer Clinical Research Center
Renton, Washington, 98057
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681
Salinas Valley Memorial Healthcare System
Salinas, California, 93901-4483
About this study
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
Read the detailed description
The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
- 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™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management appDevice
Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
| Study group | Role | What they receive |
|---|---|---|
| Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens | Experimental | All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study. Receives: Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Hypoglycemia
The overall mean percentage of time in hypoglycemia (SG < 70 mg/dL)
Measured: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Euglycemia
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Measured: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Hyperglycemia
The overall mean percentage of time in hyperglycemia (SG > 180 mg/dL)
Measured: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start6 Apr 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809285
- Sponsor's protocol ID
- CIP331
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2021
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Guardian™ Connect System With Smart Connected Devices
- ClinicalTrials.gov ID
- NCT04809285
- Acronym / sponsor ID
- CIP331
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 10 Dec 2024
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 collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
Detailed description
The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens | Experimental | Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management appAll subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Individual is 2-80 years of age at time of consent.
- A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for:
- Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and pen cartridge(s).
- Subject is currently using or is willing to use the Guardian Connect system during the study.
- Subject agrees to comply with the study protocol requirements.
Key exclusion criteria (11 listed)
- Subject is using a syringe and unwilling or unable to use insulin pen(s).
- Subject is using an insulin pump.
- Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study.
- Subject is using hydroxyurea at time of screening or plans to use it during the study.
- Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider.
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™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management appGuardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI. | Device | Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens |
Primary outcome
Percentage of Time in Hypoglycemia
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hypoglycemia (SG < 70 mg/dL)
Percentage of Time in Euglycemia
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Percentage of Time in Hyperglycemia
Time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hyperglycemia (SG > 180 mg/dL)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 14 sites in United States.
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 8 inclusion and 11 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 10 Dec 2024). 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 Time in Hypoglycemia (time frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2). The study lists 3 primary outcomes in all. 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 10 Dec 2024.