Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two types of continuous glucose monitoring systems (CGMS) to see which one helps manage blood sugar better for people aged 15 to 40 with Type 1 Diabetes Mellitus (T1DM) who are aware of when their blood sugar is low. The two systems being compared are real-time CGMS, which provides continuous updates on blood sugar levels, and intermittently scanned CGMS, which requires users to scan the device to get their readings. The goal is to find out if one system is more effective than the other in keeping blood sugar levels stable and reducing the risk of low blood sugar episodes.

To participate in this study, individuals must have had T1DM for at least two years, have an HbA1c level between 8% and 12% (which indicates average blood sugar levels), and be on a specific insulin regimen. Participants will first use one type of CGMS for two weeks, then switch to the other for another two weeks. Throughout the study, their blood sugar control will be monitored, and they will receive training on how to use the devices. It's important to note that certain medical conditions, such as kidney issues or pregnancy, may disqualify someone from participating. If you're interested, you can learn more about how this study might help improve diabetes management.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adolescents and adults aged 15-40 years with Type-1 Diabetes mellitus defined by any of the following; i. Diabetic Ketoacidosis or ketonemia or ketonuria at diagnosis with insulin dependence for survival since diagnosis OR ii. Insulin dependence for survival since diagnosis and any one of the following autoantibody positivity: GAD-65 or IA-2
• • 2. Patients on Basal bolus regimen (Glargine as basal and lispro /Aspart /Glulisine as bolus);
• • 3. Duration of Diabetes \> 2 years;
• • 4. Insulin dose requirement of at least 0.5U/kg
• • 5. HbA1c 8%-12%;
• • 6. Gold score\<4;
• • 7. No previous experience with rt-CGMS and/or is-CGMS;
• • 8. Euthyroid status;
• • 9. If hypothyroid, then on stable dose of Levothyroxine for last 3 months with normal T4 level;
• • 10. Urine albumin creatinine ratio\<300 mg/g of Creatinine;
• • 11. Those willing to give informed consent prior to enrolment.
• Exclusion Criteria:
• • 1. LADA or Secondary Diabetes
• • 2. eGFR\<60ml/min/1.73m2
• • 3. Celiac disease;
• • 4. Hb\<12g/dl for males and \<11g/dl for females;
• • 5. Hypoglycemia unawareness defined by Gold score≥4;
• • 6. HbA1c\>12%;
• • 7. Diabetic Ketoacidosis in the previous 3 months;
• • 8. Severe Non proliferative Diabetic retinopathy/Proliferative Diabetic Retinopathy/Macular edema;
• • 9. Pregnancy;
• • 10. Lactation;
• • 11. Willing to become pregnant during study;
• • 12. Requiring MRI for any existing condition;
• • 13. Any other chronic illness.