An interventional study of Standard Treatment and Carbohydrate in Diabetes Mellitus, Type I, sponsored by King Fahad Medical City. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by King Fahad Medical City · Not applicable, Interventional, and Treatment
Among 14 studies in Diabetes Mellitus, Type 1 with a site in Saudi Arabia — 6 open to participants now, 7 under way, 2 of them phase 3. Diabetes Mellitus, Type 1 · Saudi Arabia.
Among the 14 studies in Diabetes Mellitus, Type 1 with a site in Saudi Arabia, this one is the only one that started in 2023, is one of 3 with no phase, and was the 11th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 140 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →6 of the 14 studies in Diabetes Mellitus, Type 1 with a site in Saudi Arabia are open now.
A study can be open while its sites in Saudi Arabia have not opened yet or have stopped. Only those recruiting at a site in Saudi Arabia →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2023.
Median enrollment 84 across the 9 interventional studies, 5,926 across the 5 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
8 of 14 have an industry lead sponsor. The 9 most frequent:
King Fahad Medical City is the lead sponsor of 22 studies on the registry; none are open to participants now.
King Fahad Medical City has 1 study filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetes Mellitus, Type 1 with a site in Saudi Arabia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06812988SanofiTreatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule | 2027-04-29 |
| NCT07038473SanofiEarly Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF) | 2027-06-30 |
Among the 14 studies in Diabetes Mellitus, Type 1 with a site in Saudi Arabia, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or female participants aged 18-60 years Clinical diagnosis of type 1 diabetes mellitus (T1DM) for at least one year >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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
The control group followed a standard diabetic habitual diet
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.
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Percentage of Time with Glucose >250 mg/dL
Percentage of time that glucose levels exceed 250 mg/dL as measured by continuous glucose monitoring (CGM). This measure is used to assess the duration of hyperglycemia during the study period.
Time frame: From enrollment to the end of treatment at 12 weeks
Coefficient of Variation of Glucose Levels
Glucose variability (GV) will be assessed using standard deviation and coefficient of variation derived from continuous glucose monitoring data. This outcome measures the degree of glucose fluctuations throughout the study period.
Time frame: From enrollment to the end of treatment at 12 weeks
Average Glucose Level Based on CGM Data
Mean glucose levels will be calculated using CGM data collected over the 12-week study period. This outcome reflects average blood glucose concentration over time.
Time frame: From enrollment to the end of treatment at 12 weeks
Bi-Monthly Time in Range (70-180 mg/dL) from CGM
To monitor safety and trend responses over time, time in range (TIR; 70-180 mg/dL) will be assessed every 2 weeks in the intervention group using continuous glucose monitoring. This will help identify short-term changes during the course of the 12-week intervention.
Time frame: 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]
Safety will be evaluated through CGM data on hypoglycemia, including time spent with glucose levels below 70 mg/dL and the number of low-glucose events. Weight and BMI will also be monitored throughout the study period.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: No — Individual participant data will not be shared due to confidentiality and data privacy concerns.
Ran from May 2023 to primary completion in Dec 2023, 6 months.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 6 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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King Fahad Medical City