NCT06141629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

September 1, 2011

Enrollment Period

8 months

First QC Date

January 26, 2023

Last Update Submit

November 16, 2023

Conditions

Poor Glycemic ControlQuality of Life

Keywords

Metabolic controlQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • better quality of life as assessed by Hvidore questionnaire

    12 months

  • better metabolic control as assessed by glucose variability

    12 months

Study Arms (2)

Accu-Chek Aviva Expert.

ACTIVE COMPARATOR

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

Device: accu chek Aviva ExpertDevice: Accu Chek Aviva Nano

Accu check Nano

PLACEBO COMPARATOR

Accu check Nano

Device: accu chek Aviva ExpertDevice: Accu Chek Aviva Nano

Interventions

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 check NanoAccu-Chek Aviva Expert.
Accu Chek Aviva NanoDEVICE

This meter is a normal glucometer without bolus calculator.

Accu check NanoAccu-Chek Aviva Expert.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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%

You may not qualify if:

  • Insulin pump therapy
  • Missing consent declaration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

November 21, 2023

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

January 1, 2017

Last Updated

November 21, 2023

Record last verified: 2011-09

Locations

BE(1)