diabetes
Conditions
Interventions
study subjects will participate in the BolusCal education program: a structured
program concerning insulin dose adjustment based on carbohydrate counting with
the use of a personalized automated bol
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Subject is * 18 years of age. * Patient is diagnosed with Type 1 or Type 2 diabetes, with an HbA1c in the range of 48-86 mmol/mol, with either multiple hypoglycemia episodes (defined as >1 per month) or large daily variability. 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 * Subject adjusts meal insulin doses based on carbohydrate content of meals. * Subject is sub-optimally controlled at investigator*s discretion.
Exclusion criteria
Exclusion criteria: * Subject has been diagnosed with any clinically significant condition at investigator*s discretion e.g. infectious disease, major organ system disease, Gastroparesis, Psychosis or cognitive impairment, severe or moderate renal impairment, defined by an eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of the present study is to test whether a structured Bolus Calculation education program and subsequent use of the Accu-Chek® Aviva Expert with an integrated bolus advisor can improve glycemic control in carbohydrate counting-patients with type 1 or type 2 diabetes mellitus with suboptimal glycemic control. Additionally, we will asses if the BolusCal concept leads to improvements in various patient reported outcomes such as quality of life, treatment satisfaction and fear of hypoglycemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if measurements of daily glucose levels are associated with psychological factors (mood, anxiety, energy level). And if so, which glucose measurements are related to which psychological factors To determine if, in case an association is found for the question above, the type of diabetes is an effect modificator. To determine if patients with depressive disorders and/or other long term psychological problems have greater glucose fluctuations or other differences in glucose measurements. | — |
Countries
Netherlands
Outcome results
None listed