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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
NameTimeMethod
Change in HbA1c6 months
Secondary Outcome Measures
NameTimeMethod
Change in treatment satisfaction6 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 composition6 months

Assessed by electronic diet recordings

Frequency of blood glucose measurements assessed by meter download before randomization and at each visit6 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

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