Efficacy of Automated Bolus Calculation in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Education; Device: Automated bolus calculator

• 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

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-29
• Study Start: 2016-09
• Study First Posted: 2016-09-02
• Primary Completion: 2018-06
• Study Completion: 2018-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

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

Arm && Interventions

Group	Intervention	Description
Carb counting	Education	Education in carb counting and manual calculation of insulin bolus
Carb counting and bolus calculator	Education	Education in carb counting and the use of an automated bolus calculator
Carb counting and bolus calculator	Automated bolus calculator	Education in carb counting and the use of an automated bolus calculator

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