Clinical trial NCT06945744: Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes
Official title: Carbohydrate Counting /Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type I
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2025-04-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 12-week randomized controlled trial was conducted at King Fahad Medical City. Participants with T1DM who were using multiple insulin injections and Libre flash glucose monitors were randomly assigned to either CHOC-BC intervention (n = 64) or control (n = 63) group to perform conventional treatment. The primary endpoint was the time in range (TIR; 70-180 mg/dL).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time in Range 70-180 mg/dl
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Percentage of Time with Glucose >250 mg/dL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Coefficient of Variation of Glucose Levels
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Average Glucose Level Based on CGM Data
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
measure: Bi-Monthly Time in Range (70-180 mg/dL) from CGM
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Time Spent Below 70 mg/dL, Number of Hypoglycemia Events, and Changes in Weight/BMI [Safety]
timeFrame: From enrollment to the end of treatment at 12 weeks
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kinf Fahad Medical City
Study officials:
References: