Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type I
- Registration Number
- NCT06945744
- Lead Sponsor
- King Fahad Medical City
- Brief Summary
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).
- Detailed Description
This is a single-center, randomized, controlled trial evaluating the effectiveness of a mobile application, CHOC-BC, designed to assist adults with type 1 diabetes mellitus (T1DM) in carbohydrate counting and insulin bolus calculation.
The study is conducted at King Fahad Medical City over a 12-week period. Participants are randomized into two groups: the intervention group uses the CHOC-BC mobile app, while the control group continues with standard diabetes management practices.
Participants are required to use flash glucose monitoring systems and multiple daily insulin injections. The primary outcome is the percentage of time that glucose levels remain within the target range (70-180 mg/dL), assessed using continuous glucose data. Secondary outcomes include time spent in hypoglycemia and hyperglycemia, changes in body weight, and user engagement with the application.
The study seeks to determine whether digital support tools can improve glycemic outcomes and simplify self-management among adults with T1DM.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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%
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time in Range 70-180 mg/dl From enrollment to the end of treatment at 12 weeks Percentage of time that glucose levels are within the target range (70-180 mg/dL) as measured by continuous glucose monitoring (CGM). TIR will be assessed at baseline and after the 12-week intervention period.
- Secondary Outcome Measures
Name Time Method Percentage of Time with Glucose >250 mg/dL From enrollment to the end of treatment at 12 weeks Percentage of time that glucose levels exceed 250 mg/dL as measured by continuous glucose monitoring (CGM). This measure is used to assess the duration of hyperglycemia during the study period.
Coefficient of Variation of Glucose Levels From enrollment to the end of treatment at 12 weeks Glucose variability (GV) will be assessed using standard deviation and coefficient of variation derived from continuous glucose monitoring data. This outcome measures the degree of glucose fluctuations throughout the study period.
Average Glucose Level Based on CGM Data From enrollment to the end of treatment at 12 weeks Mean glucose levels will be calculated using CGM data collected over the 12-week study period. This outcome reflects average blood glucose concentration over time.
Trial Locations
- Locations (1)
Kinf Fahad Medical City
🇸🇦Riyadh, Saudi Arabia