MedTrace Logo

Carbohydrate Counting and Bolus Calculator Mobile Application Improves Time in Range in Adults With Type 1 Diabetes

NCT06945744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-04-25

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type I

Interventions

OTHER

Standard Treatment

The control group followed a standard diabetic habitual diet

DEVICE

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.

Sponsors & Collaborators

  • King Fahad Medical City

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-21
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945744 on ClinicalTrials.gov