NCT06945744Completed
Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes
Carbohydrate Counting /Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes Subjects
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
Introduction: Accurate insulin bolusing requires advanced knowledge of carbohydrate counting and correction doses, which can be supported by mobile technology. Objective: To evaluate the effectiveness and safety of a mobile application for carbohydrate counting and bolus calculation (CHOC-BC) in adults with type 1 diabetes mellitus (T1DM). Methods: This is a 12-week randomized controlled trial conducted at King Fahad Medical City. Adults with T1DM using multiple daily insulin injections and Libre flash glucose monitoring systems are randomly assigned to either the CHOC-BC intervention group or a control group receiving conventional treatment. The primary endpoint is the time in range (TIR; 70-180 mg/dL).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 15 Mar 2025
- Start date
- 21 May 2023
- Primary completion date
- 19 Dec 2023
- Lead sponsor
- King Fahad Medical City
- Diseases
- Type 1 diabetes
- NCT number
- NCT06945744
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 21 May 2023 to the primary completion date, 19 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Limited literacy Use of an insulin pump Pregnant or breastfeeding Diagnosed with ischemic heart disease Presence of multiple comorbidities where low glucose levels may pose a risk Unwillingness or inability to comply with the study protocol Following a very low-carbohydrate diet (\<10% of daily intake from carbohydrates)
Who the study is looking for
- Male or female participants aged 18-60 years Clinical diagnosis of type 1 diabetes mellitus (T1DM) for at least one year HbA1c \>6.5% (48 mmol/mol) Using multiple daily insulin injections as the method of T1DM treatment Basic knowledge of carbohydrate counting (CHOC) Regular use of a smartphone operating on iOS 13 or higher or Android 11 Active users of the Libre 2 flash glucose monitoring system Sensor capture rate greater than 30%
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kinf Fahad Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.