The DBLG1 System is contraindicated in the following cases:
- Patient receiving a total daily dose of insulin lower than 8 U
- Patient who is less than 7 years old.
- Patient suffering from a serious illness or having a treatment that might significantly impair diabetes physiology; i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids).
- Patient having severe uncorrected problems of hearing and/or visual acuity.
- Patient unable to understand and perform all of the instructions provided by Diabeloop SA.
- DO NOT wear the DBLG1 System for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The G6 has not been tested in those situations. The magnetic fields and heat could damage the components of the Dexcom G6, which may cause it to display inaccurate sensor glucose readings (readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, you might be exposed to you might miss a severe low or high glucose events. Without your blood glucose values or alarms/alerts, you may miss a severe hypoglycemic / hyperglycemic event.
- Patient who is unwilling or unable to maintain contact with his healthcare professional.
- Patient wishing to use insulin other than 100 U/mL rapid-acting insulin analog with the system (for example regular insulin; long-acting insulin analog; 200 U/mL rapid-acting insulin analog).
To find out if you personally can be prescribed from the DBLG1 System, we recommend that you speak with your diabetes specialist.