Safety and Efficacy Study of Using Smartphone-Assisted Application for Carbohydrate Counting in People with Type 1 Diabetes Mellitus

Phase 2

• Conditions: Sub-optimal glycemic control Type 1 Diabetes Mellites; Type 1 Diabetes Mellites

• Registration Number: TCTR20210923008
• Lead Sponsor: Institute of Nutrition, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Study Completion: 2023-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. People with type 1 diabetes (ICD10 code E10) with multiple daily injection at least 6 months prior the study enrollment.
2. Aged 18 - 50 years
3. Target A1C control less than or equal to 7.0 %NGSP and willing to achieve their HbA1c target
4. Able to adjust insulin by carb-insulin ratio (ICR) or sliding scale regimen.
5. Sub-optimal glycemic control, as defined by persistent HbA1c more than or equal to 8 up to 10% over 6 months prior the study enrollment.
6. Stable control of diabetes as defined by less than or equal to 10% variation in total daily insulin doses over 3 months
7. Willing to perform SMBG and currently performing SMBG more than or equal to 2 times a day.
8. No willing to lose weight. No plan for bariatric surgery or weight reduction medication. No additional structural dietary intervention or dietary pattern for specific purpose such as, but not conclusive only, intermittent fasting or low carb diet.
9. No plan for pregnancy, no pregnancy and lactation
10. No alcohol addicted and drug abuse
11. No any medication that known to alter glucose homeostasis, may including but not limited to, Oral antidiabetic drugs and GLP-1 analog, chemotherapy, glucocorticoids usage (more than 30 mg of prednisolone or equivalence) for treatment acute inflammatory diseases including arthritis, IBD or autoimmune diseases.
12. Participants must have an android smartphone and an internet service
13. Able to speak, read, write Thai

Exclusion Criteria

1. Previous history of diabetic ketoacidosis or hyperosmolar syndrome within 6 months and no severe hypoglycemia as defined by requiring another person to treat the symptom
2. Current diabetic foot ulcer, unstable Charcot foot, soft tissue infection, cellulitis or necrosis
3. Unstable angina, myocardial infarction, cerebrovascular accident, vascular intervention for coronary or peripheral at least 6 months prior the study
4. Uncontrolled hypertension as defined by SBP more than or equal to 160 or DBP more than or equal to 100 mmHg
5. Other diseases that alter glucose homeostasis, digestion, absorption may include but not limited to Cushing's syndrome, severe liver disease, CKD stage 4 to 5
6. Other diseases or conditions that alter number of erythrocyte or its production such as pernicious anemia, blood transfusion, severe blood loss at least 6 months prior the study
7. Plan to use CGMS or insulin pump during the study
8. The participants with a SMBG compliance rate during run-in period less than 80% will be excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A1C level After end of intervention HPLC,Proportion of patients who achieve A1C less than 7.0 After end of intervention Numerical count,Proportion of patients who achieve A1C less than 6.5 with and without hypoglycemia more than 2 times per month After end of intervention Numerical count

Secondary Outcome Measures

Name	Time	Method
Variation in blood glucose level During intervention SMBG,Number of blood glucose levels adverse events During intervention Numerical count