Efficacy of Automated Bolus Calculation in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— BolusCal2  

Official title:

Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887898
• Other study ID #: BolusCal2
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Automated bolus calculator

Other:
• Education

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherences to bolus calculator use	Using questionnaire	6 months
Primary	Change in HbA1c		6 months
Secondary	Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM)		6 months
Secondary	Frequency of blood glucose measurements assessed by meter download before randomization and at each visit		6 months
Secondary	Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)		6 months
Secondary	Change in diet habits/diet composition	Assessed by electronic diet recordings	6 months
Secondary	Change in treatment satisfaction	Using questionnaire	6 months