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NCT Number: NCT06141629

Benefits of a Bolus Calculator in 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.

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Key information

Conditions

Poor Glycemic Control Quality of Life

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

accu chek Aviva Expert

Device

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.

Accu Chek Aviva Nano

Device

This meter is a normal glucometer without bolus calculator.

Primary outcomes

  1. better metabolic control as assessed by HbA1C

    Time frame: 12 months

    We hypothesize that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control as assessed by HbA1C.

Secondary outcomes

  1. better quality of life as assessed by Hvidore questionnaire

    Time frame: 12 months

    quality of life as assessed by Hvidore questionnaire

  2. better metabolic control as assessed by glucose variability

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Hospital Sant Joan de Deu
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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