The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections

Prior treatment

• \- Actual treatment with CGM or previous use of CGM for more than four weeks or \< 6 months before recruitment. No actual or previous use of connected pen.
• \- One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
• \- Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.

Other illness

• \- Allergic reaction to the adhesive used in the isCGM.

Lab values

• \- Individual goal for HbA1c is reached (even if \> 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
• \- Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (\> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.

Other

• \- Fasting C-peptide \< 370 pmol/l.
• \- Considered unable to participate due to frequent cancellation of appointments.
• \- Pregnant or planning pregnancy.
• \- Participating in other trials.

• \- Type 2 DM.
• \- HbA1c \> 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
• \- Contact to diabetes clinic for ≥ 6 months.
• \- Insulin treatment ≥ 12 months.
• \- Basal insulin and bolus insulin at least for one meal every day.
• \- Bolus insulin is insulin aspart.
• \- Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
• \- Considered to be technically and intellectually capable of using isCGM and smart pen.
• \- Can communicate in Danish.
• \- Informed consent including acceptance to share glucose data from the Libreview platforms.
• \- The patient has a smart phone suitable for Libre and NOVOpen6 data registration.