MedDataX Logo

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

NCT ID: NCT06141629

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poor Glycemic Control Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accu-Chek Aviva Expert.

Accu-Chek Aviva Expert. This is a glucometer with boluscalculator.

Group Type ACTIVE_COMPARATOR

accu chek Aviva Expert

Intervention Type 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

Intervention Type DEVICE

This meter is a normal glucometer without bolus calculator.

Accu check Nano

Accu check Nano

Group Type PLACEBO_COMPARATOR

accu chek Aviva Expert

Intervention Type 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

Intervention Type DEVICE

This meter is a normal glucometer without bolus calculator.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

accu chek Aviva Expert

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.

Intervention Type DEVICE

Accu Chek Aviva Nano

This meter is a normal glucometer without bolus calculator.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZLeuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KC19092011

Identifier Type: -

Identifier Source: org_study_id