Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus
NCT ID: NCT05928260
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2023-08-10
2024-03-31
Brief Summary
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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.
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Detailed Description
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This study is a randomized control clinical 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 into rt-CGMS, is-CGMS arms and SMBG(Self Monitoring of Blood Glucose) arms respectively. For the rt-CGMS group Medtronic Guardian Connect sensor 3 will be applied for 2 weeks and and for is-CGMS group Free Style Libre will be applied for 2 weeks. The participants randomized into the 3rd group shall do self monitoring of blood glucose(SMBG) throughout the study duration of 6 months. Those participants randomized into rt-CGMS and is-CGMS groups after the end of 2 weeks will also monitor their blood glucose by SMBG till the end of 3 months.The frequency of SMBG for all these groups would be - 4 times a day( premeal blood glucose and one post meal blood glucose on rotational basis) on weekdays and 7 times on Sundays(3 times pre meals, 3 times 2 hrs post meals and once at 3 am). At the end of 3 months participants in the rt-CGMS group will undergo crossover to is-CGMS group and vice versa whereas participants in SMBG group will remain in the same arm till the end of the study(6 months).Short term blood glucose control will be assessed by Fructosamine assay after 2 weeks of CGMS application and long term control by HbA1C at the end of 3 months and 6 months. All glycemic parameters(like Time in Range, Time below Range and Time in Range will be compared in both CGMS groups before and after cross-over and both these arms will be compared with SMBG for all the outcomes.Quality of life will also be assessed in these groups by using QOLID questionnaire.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Real time CGMS(rt-CGMS)
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.
Medtronic Guardian Connect Sensor 3
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.
Intermittently scanned CGMS(is-CGMS)
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.
Abott Freestyle Libre Sensor
This system is an is-CGMS in which the participant gets his blood glucose only when the device is scanned.
Self Monitoring of Blood Glucose(SMBG)
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.
Self blood Glucose monitoring by a glucometer
In this all patients will check their blood glucose using a needle prick and glucometer at pre-specified intervals.
Interventions
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Medtronic Guardian Connect Sensor 3
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.
Abott Freestyle Libre Sensor
This system is an is-CGMS in which the participant gets his blood glucose only when the device is scanned.
Self blood Glucose monitoring by a glucometer
In this all patients will check their blood glucose using a needle prick and glucometer at pre-specified intervals.
Eligibility Criteria
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Inclusion Criteria
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
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 scoreā„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.
15 Years
40 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Sanjay K. Bhadada
Head of Department of Endocrinology,Postgraduate Institute of Medical Education and Research, Chandigarh
Principal Investigators
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Ashish Gupta, MD, Internal Medicine
Role: STUDY_DIRECTOR
Senior Resident Academic DM, Department of Endocrinology, PGIMER, Chandigarh
Locations
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Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2649-01/2023
Identifier Type: -
Identifier Source: org_study_id
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