Clinical trial NCT06141629: Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections
Official title: Benefits of a Bolus Calculator on pre-and Postprandial Glycaemic Control and Meal Flexibility of Pediatric Patients on Multiple Daily Insulin Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Glycemic Control
Quality of Life
Keywords: Metabolic control
Quality of life
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Hospital Sant Joan de Deu
First posted: 2023-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: better metabolic control as assessed by HbA1C
timeFrame: 12 months
Secondary outcomes:
measure: better quality of life as assessed by Hvidore questionnaire
timeFrame: 12 months
measure: better metabolic control as assessed by glucose variability
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References: