Efficacy of Automated Bolus Calculation in Type 2 Diabetes
BolusCal2
Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Sep 2016
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 22, 2020
January 1, 2020
1.7 years
August 15, 2016
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
6 months
Secondary Outcomes (5)
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
Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)
6 months
Change in diet habits/diet composition
6 months
Change in treatment satisfaction
6 months
Other Outcomes (1)
Adherences to bolus calculator use
6 months
Study Arms (2)
Carb counting and bolus calculator
ACTIVE COMPARATOREducation in carb counting and the use of an automated bolus calculator
Carb counting
PLACEBO COMPARATOREducation in carb counting and manual calculation of insulin bolus
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or breast feeding
- Gastroparesis
- Severe nephropathy (eGFR\<30 mL/min/1,73 m2)
- Use of sulfonylurea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Related Publications (1)
Christensen MB, Serifovski N, Herz AMH, Schmidt S, Hommel E, Raimond L, Perrild H, Gotfredsen A, Gaede P, Norgaard K. Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial. Diabetes Technol Ther. 2021 Feb;23(2):95-103. doi: 10.1089/dia.2020.0276. Epub 2020 Sep 21.
PMID: 32846108DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 15, 2016
First Posted
September 2, 2016
Study Start
September 1, 2016
Primary Completion
June 1, 2018
Study Completion
November 1, 2018
Last Updated
January 22, 2020
Record last verified: 2020-01