Diabetes Type 1NCT05029271
InPen User Experience
A study testing InPen with Guardian 4 System in people with Diabetes Type 1, run by Medtronic MiniMed, Inc. at 3 sites in Sweden.
Trial summary
The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- InPen with Guardian 4 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesSweden
- Study dates
- 17 Apr 2023to 8 Dec 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged 18-75 years at time of screening
- Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥1 year prior to screening
- Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to screening
- Subject has a Glycosylated hemoglobin (HbA1c) less than 10% as assessed by local lab <15 days prior to screening or at time of screening visit
- Subject is on MDI therapy with
- SMBG,
Show all 13Show fewer
- Continuous Glucose Monitoring (CGM), or
- Intermittent Scanning CGM (iscCGM)
- Subject is willing to upload data from a BG meter, must have internet access and a compatible computer system that meets the requirements for uploading data at home.
- Subject is willing and able to sign and date informed consent, comply with all study procedures, and wear all study devices, as required during the study.
- Subject is willing to take or switch to one of the following insulins:
- Humalog™* (insulin lispro injection)
- NovoLog™* (insulin aspart)
Who cannot join
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- Women who are breastfeeding.
- Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Subject is legally incompetent, illiterate or vulnerable person.
- Research staff involved with executing the study.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Örebro University Hospital
Örebro
NU-Hospital Group
Uddevalla
Frolunda specialist hospital
Västra Frölunda
About this study
The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.
Read the detailed description
This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy.
The total study duration will be approximately 10 weeks long for each participant.
The study consists of a run-in (phase 1) and study phases 2, 3 and 4.
Phase 1:
The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy.
Phase 2:
All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks.
Phase 3:
Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit.
Phase 4:
All subjects will utilize the InPen™ system consisting of:
- InPen™ and InPen™ Diabetes Management App
- Guardian™ 4 system (RT-CGM)
- Guardian™ 4 sensor
- Guardian™ 4 transmitter
- Guardian™ 4 app
- Conditions
- Diabetes Type 1
- Being tested
- InPen with Guardian 4 System
- Keywords
- Multiple Daily injections, Continuous Glucose Monitoring
- 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.
InPen with Guardian 4 SystemDevice
Subjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system.
| Study group | Role | What they receive |
|---|---|---|
| InPen with Guardian 4 System Arm | Other | All subjects will move from phase 1 to phase 4 of the study.
Phase 1:
Blinded Continuous Glucose Monitoring (CGM) will be utilized while subjects are on their current MDI therapy.
Phase 2:
All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App).
Phase 3:
Subjects will continue on the InPen and InPen App utilizing the HCP insights gained during the titration follow-up visit.
Phase 4:
All subjects will utilize the InPen™ with the Guardian™ 4 system. Receives: Device: InPen with Guardian 4 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoints are exploratory and descriptive related to time in glycemic range.
Percentage of Time spent within range with sensor glucose (SG) between 70-180 mg/dL (3.9-10.0 mmol/L)
Measured: Above endpoints will be categorized by daytime and night-time and overall (24hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start17 Apr 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies 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
- Model description
- Single Arm exploratory and descriptive study.
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT05029271
- Sponsor's protocol ID
- CIP338
- Status last verified
- Jan 2024
- First submitted
- 11 Aug 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InPen User Experience
- ClinicalTrials.gov ID
- NCT05029271
- Acronym / sponsor ID
- CIP338
- Conditions
- Diabetes Type 1
- Keywords
- Multiple Daily injections, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- 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 evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.
Detailed description
This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy.
The total study duration will be approximately 10 weeks long for each participant.
The study consists of a run-in (phase 1) and study phases 2, 3 and 4.
Phase 1:
The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy.
Phase 2:
All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks.
Phase 3:
Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit.
Phase 4:
All subjects will utilize the InPen™ system consisting of:
- InPen™ and InPen™ Diabetes Management App
- Guardian™ 4 system (RT-CGM)
- Guardian™ 4 sensor
- Guardian™ 4 transmitter
- Guardian™ 4 app
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm exploratory and descriptive study.
| Arm | Type | Receives |
|---|---|---|
| InPen with Guardian 4 System Arm | Other | Device: InPen with Guardian 4 SystemAll subjects will move from phase 1 to phase 4 of the study. Phase 1: Blinded Continuous Glucose Monitoring (CGM) will be utilized while subjects are on their current MDI therapy. Phase 2: All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App). Phase 3: Subjects will continue on the InPen and InPen App utilizing the HCP insights gained during the titration follow-up visit. Phase 4: All subjects will utilize the InPen™ with the Guardian™ 4 system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is aged 18-75 years at time of screening
- Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥1 year prior to screening
- Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to screening
- Subject has a Glycosylated hemoglobin (HbA1c) less than 10% as assessed by local lab <15 days prior to screening or at time of screening visit
- Subject is on MDI therapy with
Key exclusion criteria (8 listed)
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- Women who are breastfeeding.
- Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
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 |
|---|---|---|
| InPen with Guardian 4 SystemSubjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system. | Device | InPen with Guardian 4 System Arm |
Primary outcome
Endpoints are exploratory and descriptive related to time in glycemic range.
Time frame: Above endpoints will be categorized by daytime and night-time and overall (24hour).
Percentage of Time spent within range with sensor glucose (SG) between 70-180 mg/dL (3.9-10.0 mmol/L)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetes Type 1
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InPen with Guardian 4 System in people with Diabetes Type 1, run by Medtronic MiniMed, Inc. at 3 sites in Sweden.
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 13 inclusion and 8 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endpoints are exploratory and descriptive related to time in glycemic range. (time frame: Above endpoints will be categorized by daytime and night-time and overall (24hour).). 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 Jan 2024.