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InPen User Experience

Primary Purpose

Diabetes Type 1

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

InPen with Guardian 4 System

About this trial

This is an interventional other trial for Diabetes Type 1 focused on measuring Multiple Daily injections, Continuous Glucose Monitoring

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
1. SMBG,
2. Continuous Glucose Monitoring (CGM), or
3. 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:
1. Humalog™* (insulin lispro injection)
2. NovoLog™* (insulin aspart)

Exclusion Criteria:

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.

Sites / Locations

NU-Hospital Group
Frolunda specialist hospital
Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

InPen with Guardian 4 System Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05029271

First Posted

August 11, 2021

Last Updated

April 18, 2023

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT05029271

Brief Title

InPen User Experience

Official Title

InPen User Experience

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 17, 2023 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 1

Keywords

Multiple Daily injections, Continuous Glucose Monitoring

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Arm exploratory and descriptive study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

InPen with Guardian 4 System Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

InPen with Guardian 4 System

Intervention Description

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

Primary Outcome Measure Information:

Title

Endpoints are exploratory and descriptive related to time in glycemic range.

Description

Percentage of Time spent within range with sensor glucose (SG) between 70-180 mg/dL (3.9-10.0 mmol/L)

Time Frame

Above endpoints will be categorized by daytime and night-time and overall (24hour).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, 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) Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabiona Hoevelaken

Phone

+31 (0)6 115 978 31

fabiona.hoevelaken@medtronic.com

First Name & Middle Initial & Last Name or Official Title & Degree

Roseline Re

Phone

+33 (0)6 845 204 25

roseline.re@medtronic.com

Facility Information:

Facility Name

NU-Hospital Group

City

Uddevalla

Country

Sweden

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcus Lind

Facility Name

Frolunda specialist hospital

City

Vastra Frolunda

Country

Sweden

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Adolfsson

Facility Name

Örebro University Hospital

City

Örebro

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johan Jendle, Prof.

First Name & Middle Initial & Last Name & Degree

Johan Jendle, Prof.

12. IPD Sharing Statement

Plan to Share IPD

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