Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections

Benefits of a Bolus Calculator on pre-and Postprandial Glycaemic Control and Meal Flexibility of Pediatric Patients on Multiple Daily Insulin Injections

It it hypothesized that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control by concurrent use of the Accu-Chek Aviva Expert. Additionally, it is proposed that carbohydrate counting in combination with the the Accu-Chek Aviva Expert will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Poor Glycemic Control
• Intervention / Treatment: Device: accu chek Aviva Expert; Device: Accu Chek Aviva Nano

Detailed Description

Carbohydrate (Carb) counting is a meal planning approach for patients with diabetes mellitus that focuses on carbohydrate as the primary nutrient affecting postprandial glycaemic response. In the early 1990's the Diabetes Control and Complications Trial (DCCT) used Carb counting as one of its education tools. More recently, short acting insulin analogues and insulin pumps have made the role of Carb counting important and popular. Carb counting can be used to estimate carbohydrate intake and adjust insulin around mixed meals and snacks using insulin to carbohydrate ratio. This effectively addresses the variable eating habits of most children and adolescents. Carb counting can make food planning more flexible and thus more acceptable for young patients with diabetes.

Roche has recently launched the Accu-Chek Aviva Expert recently preliminary tested in adults4, being a blood glucose meter with integrated bolus calculator and memory function. This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: Current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and insulin action time.

Hypothesis:

It is hypothesized that paediatric patients in MDI therapy with suboptimal regulated diabetes will achieve better glycemic control by using Accu-Chek Aviva Expert rather than carbohydrate counting alone without the use of an external calculator.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZLeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Patients with type 1 diabetes (n=120) Age > 1 year and < 18 years
• Diabetes duration >12 months
• MDI therapy (fast acting analog for meals; long acting analog as basal)
• HbA1c > 7.0% and <11%

Exclusion Criteria:

• Insulin pump therapy
• Missing consent declaration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Accu-Chek Aviva Expert.; Accu-Chek Aviva Expert. This is a glucometer with boluscalculator.	Device: accu chek Aviva Expert; This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and quantity of insulin previously administered.; Device: Accu Chek Aviva Nano; This meter is a normal glucometer without bolus calculator.
Placebo Comparator: Accu check Nano	Device: accu chek Aviva Expert; This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and quantity of insulin previously administered.; Device: Accu Chek Aviva Nano; This meter is a normal glucometer without bolus calculator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
better metabolic control as assessed by HbA1C	We hypothesize that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control as assessed by HbA1C.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
better quality of life as assessed by Hvidore questionnaire	quality of life as assessed by Hvidore questionnaire	12 months
better metabolic control as assessed by glucose variability	We hypothesize that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control as assessed by glucose variability by concurrent use of the Accu-Chek Aviva Expert. Additionally, we propose that carbohydrate counting in combination with the the Accu-Chek Aviva Expert will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose.	12 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University of Copenhagen; Hospital Sant Joan de Deu

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Quality of life; Metabolic control
• Other Study ID Numbers: KC19092011