MaxABC study: Effect of Automated Bolus Calculation on glycemic variability and relation with psychological problems

• Subject is ≥ 18 years of age.

• Patient is diagnosed with Type 1 or Type 2 diabetes.

• HbA1c lies in the range of 48-86 mmol/mol, with either multiple hypoglycemia episodes or large variability as measured by blood glucose self-measurements and participating in the structured BolusCal Education program. HbA1c has remained stable within a range of 12 mmol/mol in the year prior to inclusion.

• Subject has had diabetes for >12 months.

• Subject has been on Multiple Daily Injections (MDI) insulin therapy for at least 6 months, consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analogue insulin for meal coverage.

• Subject adjusts meal insulin doses based on carbohydrate content of meals.

• Subject is sub-optimally controlled at investigator’s discretion.

• Patient has the willingness to measure his/her blood glucose level four to seven times a day for a period of 6 months.

• Patient’s Dutch language skills are sufficient for participation in the BolusCal program at investigator’s discretion.

• Subject has been diagnosed with any clinically significant condition at investigator’s discretion e.g.:

o Infectious disease,

o Major organ system disease,

o Gastroparesis

o Psychosis or cognitive impairment,

o Severe or moderate renal impairment, defined by an eGFR <50ml/m/1.73,

o Active proliferative retinopathy.

• Subject is on chemotherapy or radiation therapy (self-reported)

• Subject is pregnant, breast feeding or currently planning a pregnancy.

• Patient is unable to work with a PDA or smartphone, at investigator’s discreation.