Type 2 Diabetes
Conditions
Brief summary
The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.
Interventions
OTHEREducation
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes \> 1 year * Age 18 years or older * HbA1C \> 64 mmol/mol (8.0 %) * Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months * GAD-antibody negative * Naïve to bolus calculators
Exclusion criteria
* Pregnancy or breast feeding * Gastroparesis * Severe nephropathy (eGFR\<30 mL/min/1,73 m2) * Use of sulfonylurea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM) | 6 months | — |
| Frequency of blood glucose measurements assessed by meter download before randomization and at each visit | 6 months | — |
| Change in diet habits/diet composition | 6 months | Assessed by electronic diet recordings |
| Change in treatment satisfaction | 6 months | Using questionnaire |
| Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance) | 6 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherences to bolus calculator use | 6 months | Using questionnaire |
Countries
Denmark
Outcome results
None listed