Efficacy of Automated Bolus Calculation in Type 2 Diabetes
Not Applicable
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT02887898
- Lead Sponsor
- Hvidovre University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in HbA1c 6 months
- Secondary Outcome Measures
Name Time Method Change in treatment satisfaction 6 months Using questionnaire
Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM) 6 months Change in diet habits/diet composition 6 months Assessed by electronic diet recordings
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit 6 months Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance) 6 months
Trial Locations
- Locations (1)
Hvidovre University Hospital
🇩🇰Hvidovre, Denmark
Hvidovre University Hospital🇩🇰Hvidovre, Denmark