An interventional study of accu chek Aviva Expert and Accu Chek Aviva Nano in Poor Glycemic Control and Quality of Life, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Supportive care
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.
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Accu-Chek Aviva Expert. This is a glucometer with boluscalculator.
Device: accu chek Aviva Expert · Device: Accu Chek Aviva Nano
Accu check Nano
Device: accu chek Aviva Expert · Device: Accu Chek Aviva Nano
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.
This meter is a normal glucometer without bolus calculator.
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.
Time frame: 12 months
better quality of life as assessed by Hvidore questionnaire
quality of life as assessed by Hvidore questionnaire
Time frame: 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.
Time frame: 12 months
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven