Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes
NCT ID: NCT06945744
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2023-05-21
2023-12-19
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Standard Treatment
The control group followed a standard diabetic habitual diet
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.
Carbohydrate
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.
Interventions
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Standard Treatment
The control group followed a standard diabetic habitual diet
Carbohydrate
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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King Fahad Medical City
OTHER_GOV
Responsible Party
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Sara Albabtain
Senior Clinical Dietitian
Locations
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Kinf Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia
Countries
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Related Links
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Carbohydrate Counting and bolus calculator Application
Other Identifiers
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023-015
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
22-630
Identifier Type: -
Identifier Source: org_study_id
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