InPen User Experience

NCT05029271 | Completed

• 1 other identifier: CIP338
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Type 1

Keywords

Multiple Daily injections; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

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

Study Arms (1)

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.

Device: InPen with Guardian 4 System

Interventions

InPen with Guardian 4 System DEVICE

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

InPen with Guardian 4 System Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (3)

Örebro University Hospital

Örebro, Sweden

Location

NU-Hospital Group

Uddevalla, Sweden

Location

Frolunda specialist hospital

Västra Frölunda, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm exploratory and descriptive study.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 31, 2021
• Study Start: April 17, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)