Poor Glycemic ControlNCT06141629
Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections
A study testing accu chek Aviva Expert and Accu Chek Aviva Nano in people with Poor Glycemic Control and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Poor Glycemic Control, Quality of Life
- What is being tested?
- accu chek Aviva Expert and Accu Chek Aviva Nano
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - 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%
Who cannot join
- Insulin pump therapy
- Missing consent declaration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of a Bolus Calculator on pre-and Postprandial Glycaemic Control and Meal Flexibility of Pediatric Patients on Multiple Daily Insulin Injections
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.
Read the 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.
- Conditions
- Poor Glycemic Control, Quality of Life
- Being tested
- accu chek Aviva Expert, Accu Chek Aviva Nano
- Keywords
- Metabolic control, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accu chek Aviva ExpertDevice
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 NanoDevice
This meter is a normal glucometer without bolus calculator.
| Study group | Role | What they receive |
|---|---|---|
| Accu-Chek Aviva Expert. | Active comparator | Accu-Chek Aviva Expert. This is a glucometer with boluscalculator. Receives: Device: accu chek Aviva Expert; Device: Accu Chek Aviva Nano |
| Accu check Nano | Placebo comparator | Accu check Nano Receives: Device: accu chek Aviva Expert; Device: Accu Chek Aviva Nano |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
better quality of life as assessed by Hvidore questionnaire
quality of life as assessed by Hvidore questionnaire
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startJan 2015
- Primary completionSep 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Glycemic ControlStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Hospital Sant Joan de Deu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141629
- Sponsor's protocol ID
- KC19092011
- Status last verified
- Sep 2011
- First submitted
- 26 Jan 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Bolus Calculator on pre-and Postprandial Glycaemic Control and Meal Flexibility of Pediatric Patients on Multiple Daily Insulin Injections
- ClinicalTrials.gov ID
- NCT06141629
- Acronym / sponsor ID
- KC19092011
- Conditions
- Poor Glycemic Control, Quality of Life
- Keywords
- Metabolic control, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Hospital Sant Joan de Deu
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accu-Chek Aviva Expert. | Active comparator | Device: accu chek Aviva Expert, Device: Accu Chek Aviva NanoAccu-Chek Aviva Expert. This is a glucometer with boluscalculator. |
| Accu check Nano | Placebo comparator | Device: accu chek Aviva Expert, Device: Accu Chek Aviva NanoAccu check Nano |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- - 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%
Key exclusion criteria (2 listed)
- Insulin pump therapy
- Missing consent declaration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| accu chek Aviva ExpertThis 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. | Device | Accu check Nano, Accu-Chek Aviva Expert. |
| Accu Chek Aviva NanoThis meter is a normal glucometer without bolus calculator. | Device | Accu check Nano, Accu-Chek Aviva Expert. |
Primary outcome
better metabolic control as assessed by HbA1C
Time frame: 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.
2 secondary outcomes
better quality of life as assessed by Hvidore questionnaire
Time frame: 12 months
better metabolic control as assessed by glucose variability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Related trials for Poor Glycemic Control
Not yet recruitingPhase 2
Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Poor Glycemic Control Despite Lifestyle Intervention
Diabetes Mellitus, Type 2
Recruiting
ED Diabetes Screening and Outpatient Care - Aim 3
Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus
Active, not recruitingPhase 3
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)
Active, not recruitingPhase 3
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise
Type 2 Diabetes Mellitus (T2DM)
RecruitingPhase 4
Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
T2DM (Type 2 Diabetes Mellitus)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accu chek Aviva Expert and Accu Chek Aviva Nano in people with Poor Glycemic Control and Quality of Life, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
better metabolic control as assessed by HbA1C (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.