Type 1 diabetes
Conditions
Interventions
Phase 1:
Enrollment (Visit 1) and Screening/Start Run-in (baseline/Visit 2) The purpose
of the run-in phase is to collect data for two weeks while subjects are on
their current MDI therapy. Blinded
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 12% as assessed by local lab or capillary blood testing
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| N/A only descriptive endpoints for this study | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A only descriptive endpoints for this study | — |
Countries
Netherlands
Outcome results
None listed