InPen User Experience

January 9, 2024 updated by: Medtronic Diabetes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uddevalla, Sweden
        • NU-Hospital Group
      • Vastra Frolunda, Sweden
        • Frolunda specialist hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is aged 18-75 years at time of screening
  2. Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥1 year prior to screening
  3. Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to screening
  4. 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

  5. Subject is on MDI therapy with

    1. SMBG,
    2. Continuous Glucose Monitoring (CGM), or
    3. Intermittent Scanning CGM (iscCGM)
  6. 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.
  7. 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.

  8. Subject is willing to take or switch to one of the following insulins:

    1. Humalog™* (insulin lispro injection)
    2. NovoLog™* (insulin aspart)

Exclusion Criteria:

  1. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
  2. Women who are breastfeeding.
  3. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  4. 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.
  5. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
  6. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
  7. Subject is legally incompetent, illiterate or vulnerable person.
  8. Research staff involved with executing the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: InPen with Guardian 4 System Arm

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.
Device: InPen with Guardian 4 System
Subjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Above endpoints will be categorized by daytime and night-time and overall (24hour).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

December 8, 2023

Study Completion (Actual)

December 8, 2023

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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