Carbohydrate Counting /Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King Fahad Medical City
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Time in Range 70-180 mg/dl
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
Exclusion Criteria
- •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)
Arms & Interventions
Participants receiving standard diabetes education
The control group received a standard diabetic educational diet plan emphasizing regular meal timing and distribution. This plan included three main meals and 2-3 snacks daily while encouraging the avoidance of high glycemic and high-fat foods.
Intervention: Standard Treatment (Other)
Participants using the Carbohydrate Counting/Bolus Calculator Mobile Application
Eligible participants provided informed consent and underwent baseline assessments, including demographics, medical history, insulin doses, and fasting blood samples for HbA1c and lipid profile. Participants used the FreeStyle Libre 2 sensor, with AGP data collected bimonthly. The primary outcome was Time in Range (TIR, 70-180 mg/dL), while secondary outcomes included TAR, TBR, GV%, GMI, HbA1c, and BMI.
A registered dietitian provided structured CHOC-BC education. The intervention group used the CHOC-BC app, validated against expert-calculated carbohydrate counts, while the control group followed standard diabetes education. Virtual follow-ups occurred bimonthly for three months. At study completion, HbA1c, lipid profile, insulin doses, weight, and AGP data were collected for comparison.
Intervention: Carbohydrate (Device)
Outcomes
Primary Outcomes
Time in Range 70-180 mg/dl
Time Frame: 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 Outcomes
- Percentage of Time with Glucose >250 mg/dL(From enrollment to the end of treatment at 12 weeks)
- Coefficient of Variation of Glucose Levels(From enrollment to the end of treatment at 12 weeks)
- Average Glucose Level Based on CGM Data(From enrollment to the end of treatment at 12 weeks)
Investigators
Sara Albabtain
Senior Clinical Dietitian
King Fahad Medical City