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

Korábbi kezelés

• - 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.

Más betegség

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

Laborértékek

• - 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.

Egyéb

• - 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.