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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Poor Glycemic Control, Quality of Life

Intervention / Treatment
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* Device: accu chek Aviva Expert
* Device: Accu Chek Aviva Nano


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Accu-Chek Aviva Expert.<br>Accu-Chek Aviva Expert. This is a glucometer with boluscalculator. | Device: accu chek Aviva Expert<br>* 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.<br>Device: Accu Chek Aviva Nano<br>* This meter is a normal glucometer without bolus calculator.<br>|
| Placebo Comparator: Accu check Nano<br>Accu check Nano | Device: accu chek Aviva Expert<br>* 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.<br>Device: Accu Chek Aviva Nano<br>* This meter is a normal glucometer without bolus calculator.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic control, Quality of life