Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections
- Conditions
- Poor Glycemic ControlQuality of Life
- Interventions
- Device: accu chek Aviva ExpertDevice: Accu Chek Aviva Nano
- Registration Number
- NCT06141629
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
- 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%
- Insulin pump therapy
- Missing consent declaration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Accu check Nano Accu Chek Aviva Nano Accu check Nano Accu-Chek Aviva Expert. Accu Chek Aviva Nano Accu-Chek Aviva Expert. This is a glucometer with boluscalculator. Accu check Nano accu chek Aviva Expert Accu check Nano Accu-Chek Aviva Expert. accu chek Aviva Expert Accu-Chek Aviva Expert. This is a glucometer with boluscalculator.
- Primary Outcome Measures
Name Time Method better metabolic control as assessed by HbA1C 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 Outcome Measures
Name Time Method better quality of life as assessed by Hvidore questionnaire 12 months quality of life as assessed by Hvidore questionnaire
better metabolic control as assessed by glucose variability 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.
Trial Locations
- Locations (1)
UZLeuven
🇧🇪Leuven, Belgium