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

NCT05928260 | Unknown FDA Device

• 1 other identifier: 2649-01/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients.Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. real-time CGMS (rt-CGMS) and intermittently scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established. This study is a randomized control clinical cross over study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1:2 in rt-CGMS, is-CGMS and SMBG (self monitoring of blood glucose) arms, respectively. For the first two groups Medtronic Guardian Connect Sensor 3 and Abott Freestyle Libre Sensor 2will be applied for 2 weeks, respectively; followed by a crossover at 3 months withapplication of is-CGMS and rt-CGMS, respectively in these groups for a further 2 weeks period. For rest of the study duration these patients in the rt-CGMS and is-CGMS group will be monitored through SMBG. The 3rd SMBG group will act as control. Short term blood glucose control will be assessed by Fructosamine assay in the 2 CGMS groups and long term control by HbA1C.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Composite outcome of blood glucose control over the preceding 3 months at time=3 months from the start of the study, It will be measured in % using VARIANTII TURBO Hemoglobin Testing System- Bio Rad.

  3 months

Secondary Outcomes (7)

• HbA1c

  6 months

• Fructosamine levels in the CGMS groups

  At baseline , 2 weeks, 3 months and 3 months 2 weeks.

• Mean sensor glucose

  After the first device(2 weeks) and after 2nd device(3 months 2 weeks)

• Standard deviation of Sensor Glucose

  After the first device(2 weeks) and after 2nd device(3 months 2 weeks)

• Coefficient of Variation(CV)

  After the first device(2 weeks) and after 2nd device(3 months 2 weeks)

Study Arms (3)

Real time CGMS(rt-CGMS)

ACTIVE COMPARATOR

Medtronic Guardian Connect sensor 3 will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control.

Device: Medtronic Guardian Connect Sensor 3

Intermittently scanned CGMS(is-CGMS)

ACTIVE COMPARATOR

Abott Freestyle Libre Sensor will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control.

Device: Abott Freestyle Libre Sensor

Self Monitoring of Blood Glucose(SMBG)

PLACEBO COMPARATOR

This group will monitor blood glucose using glucometer and needle pricks throughout the study duration and insulin doses will be adjusted based on these readings as per the standard management of Type-1 Diabetes Mellitus patients endorsed by American Diabetic Association in 2023.

Other: Self blood Glucose monitoring by a glucometer

Interventions

Medtronic Guardian Connect Sensor 3 DEVICE

This is a real-time CGMS which transmits all the blood glucose readings into the application downloaded in a device continuously and also gives alarms and alerts to the person.

Real time CGMS(rt-CGMS)

Abott Freestyle Libre Sensor DEVICE

This system is an is-CGMS in which the participant gets his blood glucose only when the device is scanned.

Intermittently scanned CGMS(is-CGMS)

Self blood Glucose monitoring by a glucometer OTHER

In this all patients will check their blood glucose using a needle prick and glucometer at pre-specified intervals.

Self Monitoring of Blood Glucose(SMBG)

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Patients on Basal bolus regimen (Glargine as basal and lispro /Aspart /Glulisine as bolus);
• Duration of Diabetes \> 2 years;
• Insulin dose requirement of at least 0.5U/kg
• HbA1c 8%-12%;
• Gold score\<4;
• No previous experience with rt-CGMS and/or is-CGMS;
• Euthyroid status;
• If hypothyroid, then on stable dose of Levothyroxine for last 3 months with normal T4 level;
• Urine albumin creatinine ratio\<300 mg/g of Creatinine;
• Those willing to give informed consent prior to enrolment.

You may not qualify if:

• LADA or Secondary Diabetes
• eGFR\<60ml/min/1.73m2
• Celiac disease;
• Hb\<12g/dl for males and \<11g/dl for females;
• Hypoglycemia unawareness defined by Gold score≥4;
• HbA1c\>12%;
• Diabetic Ketoacidosis in the previous 3 months;
• Severe Non proliferative Diabetic retinopathy/Proliferative Diabetic Retinopathy/Macular edema;
• Pregnancy;
• Lactation;
• Willing to become pregnant during study;
• Requiring MRI for any existing condition;
• Any other chronic illness.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Study Officials

• Ashish Gupta, MD, Internal Medicine

  Senior Resident Academic DM, Department of Endocrinology, PGIMER, Chandigarh

  STUDY DIRECTOR

Central Study Contacts

Sanjay Bhadada, DM Endo

CONTACT

+919876602448; bhadadask@rediffmail.com

Soham Mukherjee, DM Endo

CONTACT

+919914743222; drsoham.mukherjee@googlemail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Endocrinology,Postgraduate Institute of Medical Education and Research, Chandigarh

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 3, 2023
• Study Start: August 10, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

IN (1)