InPenTM User Experience

Withdrawn

Conditions: Type 1 diabetes
10018424

Registration Number: NL-OMON51113

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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
a. SMBG,
b. Continuous Glucose Monitoring (CGM), or
c. 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:
a. Humalog** (insulin lispro injection)
b. 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.