NCT05029271Completed
InPen User Experience
Source: ClinicalTrials.gov · Last updated 10 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 11 Aug 2021
- Start date
- 17 Apr 2023
- Primary completion date
- 8 Dec 2023
- Lead sponsor
- Medtronic MiniMed, Inc.
- Diseases
- Type 1 diabetes
- NCT number
- NCT05029271
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 17 Apr 2023 to the primary completion date, 8 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
Other
- 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 is legally incompetent, illiterate or vulnerable person.
- Research staff involved with executing the study.
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Örebro University Hospital Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| NU Hospital Group Coordinator of this site? Confirm its status | Uddevalla | Sweden | Unknown status |
| Frolunda specialist hospital Coordinator of this site? Confirm its status | Västra Frölunda | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.