Status:
COMPLETED
Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes
Lead Sponsor:
King Fahad Medical City
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
18-60 years
Phase:
NA
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 effectivenes...
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 coun...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06945744
Start Date
May 21 2023
End Date
December 19 2023
Last Update
April 25 2025
Active Locations (1)
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1
Kinf Fahad Medical City
Riyadh, Riyadh Region, Saudi Arabia, 12231