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

NCT06945744 | Completed

• 2 other identifiers: 22-630023-015
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type I

Outcome Measures

Primary Outcomes (1)

• Time in Range 70-180 mg/dl

  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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• 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

Other Outcomes (2)

• Bi-Monthly Time in Range (70-180 mg/dL) from CGM

  From enrollment to the end of treatment at 12 weeks

• Time Spent Below 70 mg/dL, Number of Hypoglycemia Events, and Changes in Weight/BMI [Safety]

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Participants receiving standard diabetes education

ACTIVE COMPARATOR

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.

Other: Standard Treatment

Participants using the Carbohydrate Counting/Bolus Calculator Mobile Application

EXPERIMENTAL

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.

Device: Carbohydrate

Interventions

Standard Treatment OTHER

The control group followed a standard diabetic habitual diet

Participants receiving standard diabetes education

Carbohydrate DEVICE

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.

Participants using the Carbohydrate Counting/Bolus Calculator Mobile Application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

Kinf Fahad Medical City

Riyadh, Riyadh Region, 12231, Saudi Arabia

Location

Related Links

• Carbohydrate Counting and bolus calculator Application

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Dietitian

Model Details: 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).

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: April 25, 2025
• Study Start: May 21, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)