Comparing two types of continuous glucose monitoring in young adults with Type 1 Diabetes

Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus: an Open Label Randomised Control Cross Over Study

This study is testing which type of continuous glucose monitoring—real-time or intermittently scanned—works better for young adults with Type 1 Diabetes to help them manage their blood sugar levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 15 Years to 40 Years
• Sex: All
• Sponsor: Pgimer
• Locations: 1 site (Chandigarh)
• Trial ID: NCT05928260 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of real-time continuous glucose monitoring systems (rt-CGMS) versus intermittently scanned continuous glucose monitoring systems (is-CGMS) in adolescents and adults aged 15-40 years with Type 1 Diabetes Mellitus (T1DM) who have normal hypoglycemic awareness. The study involves a randomized crossover design over six months, where participants will be assigned to one of three groups: rt-CGMS, is-CGMS, or self-monitoring of blood glucose (SMBG). After a two-week training period, participants will use either the Medtronic Guardian Connect sensor or the Abbott Freestyle Libre sensor for two weeks, followed by monitoring their blood glucose levels. The goal is to determine which monitoring method provides better glycemic control and reduces variability in blood glucose levels.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 15-40 years with Type 1 Diabetes and an HbA1c level between 8-12%.

Not a fit: Patients with secondary diabetes or those with significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glycemic control and reduced hypoglycemic episodes for patients with Type 1 Diabetes.

How similar studies have performed: Previous studies have indicated that rt-CGMS is superior to is-CGMS in certain populations, but this specific comparison in patients with normal hypoglycemic awareness is less established.

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.

Where this trial is running

Chandigarh

• Post Graduate Institute of Medical Education and Research — Chandigarh, India (Recruiting)

Study contacts

• Study coordinator: Sanjay Bhadada, DM Endo

Conditions Type1 Diabetes Mellitus