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
Phase: NA
Conditions: Type1 Diabetes Mellitus
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

 1 
COVER LETTER 
 
 
 
 
To 
Clinical Trials PRS Registration System 
Dated: 08/06/2023 
 
Subject: Submission of a project termed “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” 
Dear sir/madam; 
This is to certify that I’m hereby submitting a project entitled “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”for 
registration. 
 
Regards 
Dr Sanjay Kumar Bhadada  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 2 
PLAN OF PROJECT 
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 
 
 
PRINCIPAL INVESTIGATOR 
 
 
 
 
 
 
CO- INVESTIGATOR 
DR. SOHAM MUKHERJEE 
ASSISTANT PROFESSOR 
DEPARTMENT OF ENDOCRINOLOGY 
PGIMER, CHANDIGARH 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
  
DR. SANJAY KUMAR BHADADA 
PROFESSOR & HEAD 
DEPARTMENT OF ENDOCRINOLOGY 
PGIMER, CHANDIGARH 
 
 
  
  

 3 
 
 
 
 
 
 
CONTENTS 
 
SR. 
NO. TITLE 
Page no 
1. 
INTRODUCTION 
5 
2. 
REVIEW OF LITERATURE 
9 
3. 
AIMS AND OBJECTIVES 
          20 
4. 
MATERIALS AND METHODS 
21 
5. 
METHODOLOGY 
24 
6. 
STATISTICAL ANALYSIS 
33 
7. 
ETHICAL  JUSTIFICATION 
34 
8. 
REFERENCES 
          35 
   9. 
QOLID Questionnaire 
40 
 
 
 
 
 
 
 
 

 4 
LIST OF ABBREVATIONS 
ABF 
After Breakfast Plasma Glucose 
ADN 
After Dinner Plasma Glucose 
AGE 
Advanced Glycation End product 
ALN 
After lunch plasma glucose 
aOR 
Adjusted Odds ratio 
ANOVA 
Analysis of variance 
BDN 
Before Dinner Plasma Glucose 
BMI 
Body Mass Index 
BLN 
Before Lunch Plasma Glucose 
CGM(S) 
Continuous Glucose Monitoring (System) 
CI 
Confidence interval 
CSII 
Continuous Subcutaneous Insulin Infusion 
ECLIA 
Electro Chemi Luminescence immuno assay 
DR 
Diabetic Retinopathy 
eGFR 
Estimated glomerular filtration rate  
FGM 
Flash Glucose Monitoring 
FPG 
Fasting plasma glucose 
FSLP 
Free Style Libre Pro 
HbA1c 
Glycated hemoglobin 
IAH 
Impaired Awareness of Hypoglycemia 

 5 
ICR 
Insulin Carbohydrate Ratio 
ISF 
Insulin Sensitivity Factor 
IgA-tTG 
Tissue transglutaminase  
is-CGM(S) 
Intermittently scanned CGM(S) 
LADA 
Latent autoimmune diabetes of adulthood 
LH 
Luteinising hormone 
MSI 
Multiple Subcutaneous Injections 
OGTT 
Oral glucose tolerance test 
PPPG 
Post prandial plasma glucose 
RCT 
Randomized control trial 
Rt-CGM(S) 
Real time continuous Glucose Monitoring (System) 
SMBG 
Self Monitoring of Blood Glucose 
T1D 
Type 1 diabetes mellitus 
T2D 
Type 2 diabetes mellitus 
ULN 
Upper limit of Normal 
 
 
 
 
 
 
 
 
 

 6 
 
INTRODUCTION 
Type 1 diabetes accounts for 10–15% of the worldwide diabetes prevalence and its 
incidence is increasing worldwide by 3–5%percent annually (1). Optimal glycaemic 
control is inevitable to prevent microvascular and macrovascular complications of the 
disease, however patients on intensive control regimes are at risk for hypoglycaemia 
(2,3,4). 
Glucose measurements are critically important for effective diabetes control. Currently, 
measurements performed by patients from capillary blood (self-monitoring of blood 
glucose, SMBG) are the golden standard of routine care (5). It has been demonstrated 
that frequent testing regimes improve glycaemic control (6,7) however, increasing the 
number of finger pricking above a certain threshold might yield no additional benefits 
but reflect badly on patient's quality of life (8). 
However, SMBG only provides information about a single time-point, it does not 
accurately reflect the glycaemic variability and often is painful and cumbersome.  
Only approximately 30% of individuals with type 1 diabetes meet the American 
Diabetes Association goal of hemoglobin A1c (HbA1c) level of 7.5% (58 mmol/mol) 
for children (<18 years) and 7.0% (53 mmol/mol) for adults (≥18 years), (9) indicating 
the need for better approaches to diabetes management, CGMS represents such an 
approach. CGMS systems measure glucose in the interstitial fluid and are currently 
divided into real-time continuous systems (rt-CGMS) and intermittently scanned 
systems (is-CGMS). These systems allow a semi-continuous insight, not only in 
glucose concentrations, but also in trends in time. Rt-CGM systems automatically 
transmit data to the receiver and/or smartphone, whereas is-CGM systems require a 

 7 
person to "swipe" the receiver and/or smartphone close to the sensor to obtain current 
and historical sensor glucose data. A key differentiator between these technologies was 
the added safeguard of active alarms/alerts. New is-CGM systems offer optional alerts 
that warn users when glucose levels fall below or rise above the programmed threshold; 
however, the current iteration of these technologies do not warn users of predicted low 
or high glucose levels. Both rt-CGM and is-CGM technologies are available as 
standalone devices. Some of the indications for continuous glucose monitoring in adults 
with Type 1 DM are as follows (10): 
• All persons with diabetes treated with intensive insulin therapy, defined as 3 or 
more injections of insulin per day or the use of an insulin pump 
• All 
individuals 
with 
problematic 
hypoglycaemia 
(frequent/severe 
hypoglycaemia, nocturnal hypoglycaemia, hypoglycaemia unawareness). 
• Children/adolescents with T1D. 
• Pregnant women with T1D and T2D treated with intensive insulin therapy. 
Other indications: 
• Women with gestational diabetes mellitus (GDM) on insulin therapy. 
• Adults undergoing change in their diabetes regimen. 
• Postprandial hyperglycaemia. 
• Patients with discrepancies between HbA1c and SMBG. 
• Patients unable to achieve goal with SMBG 
Currently following CGM systems are available in India: 
 Free Style Libre pro  
 Free Style Libre 
 Dexcom G6 platinum 
 Medtronic’s Guardian Connect 

 8 
Key differences between is-CGMS (FSLP) and rt-CGMS(Medtronic Guardian 3) are 
as follows: 
 
Abbott Libre (FSLP) Medtronic Guardian 3 
Age(FDA approved) ≥18yrs 
≥2yrs 
rt-CGM or is-CGM 
is-CGM 
rt-CGM 
Surgically implanted No 
No 
Sensor life 
14days 
7-10days 
BG readings 
Every 15mins  
Every 5 mins 
Alarms/alerts  
No  
Yes 
Ability to share  
Yes  
Indirectly  
Warm up 
1 hour 
Less than 2 hours 
 
Use of CGM is associated with a reduction in HbA1c (11), and reduced exposure to, 
and risk of hypoglycaemia (12) in people using insulin pump and multiple-dose 
injection regimens (13). The impact on glucose and hypoglycaemia outcomes has 
additionally been confirmed in people with Type 1 diabetes and impaired 
hypoglycaemia awareness (14).  
Superiority of rt-CGMS in comparison to SMBG for glycaemic control and reduction 
of number of hypoglycaemic events is clearly established in multiple RCTs 
(15,16,17,18,19). Many studies comparing is-CGM with SMBG are also available. 
Large randomized controlled trials using flash CGM have demonstrated significant 
improvements in hypoglycaemia, glycaemic variability, and patient satisfaction in 
individuals with well-controlled T1D (20) and T2D (21) who were treated with 
intensive insulin therapy. Improvements in glycated haemoglobin A1c (HbA1c) and 
percentage of time within the target glucose range were observed in T1D (20) but not 

 9 
T2D (21) patients. Moreover, recent real-world observational studies have reported 
significant reductions in hospital admissions for severe hypoglycaemia and/or diabetic 
ketoacidosis in large cohorts of T1D adults who used flash CGM for 12 months (22,23).  
However, studies comparing rt-CGMS vs is-CGMS in adult T1D patients are scarce. 
Rt-CGMS has been shown to be better compared to is-CGMS especially in patients 
with impaired hypoglycaemic awareness (24,25) but in patients with normal 
hypoglycaemic awareness it is not proven. A recent study published in 2020 included 
adults with type 1 diabetes (T1D) and normal hypoglycaemia awareness (Gold score 
<4) comparing rt-CGM (Guardian Connect Mobile) or is-CGM (Free Style Libre) in 
exercise phase and in the home phase revealed that rt-CGM was superior to is-CGM in 
reducing hypoglycaemia and improving time in range in adults with T1D with normal 
hypoglycaemia awareness (26). 
However, it had many limitations like: 
1. Short duration: Study duration was 4 weeks only so it could not assess the effect 
on long term glycemic control in term of HbA1C reduction 
2. Cross over between rtCGM and isCGM was not done. 
3. CGM was worn continuously for 4 days in exercise phase and 4 weeks for home 
phase which is not practical in a resource constraint setting. 
Hence, there arises a need for more studies comparing rt-CGMS and is-CGMS in 
resource constraint settings like ours. 
 
 
 
 
 

 10 
REVIEW OF LITERATURE 
CGMS (rt-CGMS and is-CGMS) vs SMBG in T1D 
There are various studies comparing CGMS mostly rt-CGMS with SMBG in T1D 
patients, some of which are as follows:  
 
 
 
IMPACT 
study (20) 
239 T1D pt with Hba1c 
6.9% at baseline 
Use of is-CGM is a/w 38% reduction in 
time spent in hypoglycemia(<70) 
DIAMOND 
trial (15) 
158 T1D with HbA1c 
7.5-9.9% on MSI, rt-
CGM 
compared 
to 
SMBG 
Lower HbA1c(-1% vs 0.4%, p<0.001) at 
24 
weeks 
TBR(-22min 
vs 
37min,  
p=0.002) TAR(-78 vs 78mins, p<0.001) 
GOLD study 
(27) 
6months cross over, 
142 adult T1D patients 
CGMS vs conventional 
on HbA1c at 26 weeks 
HbA1c was 7.92%(63 mmol/mol) during 
CGMS and 8.35%(68 mmol/mol) during 
conventional 
(mean 
difference,−0.43%[95%CI, 
−0.57%to 
−0.29%] or −4.7 [−6.3 to −3.1 mmol/mol]; 
P < .001) 
HypoDE 
study (16) 
141 T1D pts, number of 
hypoglycemic events in 
follow up phase(22-
26)weeks 
were 
compared in rt-CGM vs 
SMBG 
No. of hypoglycemic events in rt-CGM 
decreased from 10.4 to 3.4% whereas in 
control 13.5 to 13.2% 

 11 
GOLD 
-
3(28) 
rt-CGM  vs SMBG, 161 
T1D patients over a 
period of 69 weeks, 
duration of  episodes of 
nocturnal 
hypoglycemia 
Decrease in nocturnal hypoglycemia  
<70-19.6 to 10.2min 
<54-8.9 to 3.1 min 
Daytime hypoglycemia 49 to 29min/d 
RESCUE 
study(29) 
rt-CGM vs SMBG in 
441 T1D patients over 
24 months 
Significant 
reductions 
in 
no. 
of 
hypoglycaemia and DKA hospitalization 
Meta-
analysis 
of 
RCTs  
Dicembrini 
etal(30) 
Meta-analysis of RCTs 
comparing CGMS vs 
SMBG in T1D patients 
CGM was associated with a significantly 
lower HbA1c at endpoint in comparison 
with SMBG (− 0.24 [− 0.34,− 0.13]%); and 
a significantly lower risk of severe 
hypoglycemia than SMBG. 
 
Bolinder etal conducted a multicentre, prospective, non-masked, randomised controlled 
trial(20), with adult patients with well controlled type 1 diabetes (HbA1c ≤58 
mmol/mol [7·5%]) from 23 European diabetes centres in which all participants wore 
the blinded sensor for 2 weeks and, those with readings for at least 50% of the period 
were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention 
group) or to self-monitoring of blood glucose with capillary strips (control group).The 
primary outcome was change in time in hypoglycaemia (<3·9 mmol/L [70 mg/dL]) 
between baseline and 6 months in the full analysis set. Between Sept 4, 2014, and Feb 
12, 2015, 120 participants were randomly assigned to the intervention group and 121 
to the control group. They found mean time in hypoglycaemia changed from 3·38 h/day 

 12 
at baseline to 2·03 h/day at 6 months (baseline adjusted mean change −1·39) in the 
intervention group, and from 3·44 h/day to 3·27 h/day in the control group (−0·14); 
with the between-group diff erence of −1·24 (SE 0·239; p<0·0001), equating to a 38% 
reduction in time in hypoglycaemia in the intervention group and no device-related 
hypoglycaemia or safety issues.13 adverse events were reported by ten participants 
related to the sensor—four of allergy events (one severe, three moderate); one itching 
(mild); one rash (mild); four insertion-site symptom (severe); two erythema (one 
severe, one mild); and one oedema (moderate). They concluded Novel flash glucose is-
CGMS reduced the time adults with well controlled type 1 diabetes spent in 
hypoglycaemia. 
Beck etal conducted a Randomized clinical trial conducted between October 2014 and 
May  2016 at 24 endocrinology practices in the United States that included 158 adults 
with type 1 diabetes who were using multiple daily insulin injections and had 
hemoglobin A1c (HbA1c) levels of 7.5%to 9.9%.Random assignment 2:1 toCGM(n = 
105) or usual care (control group; n = 53) was done in this study and the difference in 
change in central-laboratory–measured HbA1c level was compared from baseline to 24 
weeks. Also, secondary outcome as duration of hypoglycemia at less than 70mg/dL, 
measured with CGM for 7 days at 12 and 24 weeks was reported. It was found that 
mean HbA1c reduction from baseline was 1.1%at 12 weeks and 1.0% at 24 weeks in 
the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-
measures model P < .001). At 24 weeks, the adjusted treatment-group difference in 
mean change in HbA1c level from baseline was –0.6%(95%CI, –0.8%to –0.3%; P < 
.001) and median duration of hypoglycemia at less than <70mg/dL was 43 min/d (IQR, 
27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). 
Severe hypoglycemia events occurred in 2 participants in each group. This trial 

 13 
revealed that among adults with type 1 diabetes who used multiple daily insulin 
injections, the use of CGM compared with usual care resulted in a greater decrease in 
HbA1c level during 24 weeks.  
Lind etal conducted an open-label crossover randomized clinical trial conducted in 15 
diabetes  outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 
that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at 
least 7.5%(58 mmol/mol) treated with MSIs in which participants were randomized to 
receive treatment using a CGMS or conventional treatment for 26 weeks, separated by 
a washout period of 17 weeks and compared the difference in HbA1c between weeks 
26 and 69 for the 2 treatments and also studied adverse events including severe 
hypoglycemia. In this trial, 161 (45.3% women) randomized participants with a  mean 
age was 43.7 years, with mean HbA1c was 8.6%(70 mmol/mol) but only 142 
participants had follow-up data in both treatment periods. It was found that mean 
HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 
8.35%(68 mmol/mol) during conventional treatment (mean difference,−0.43%[95%CI, 
−0.57%to −0.29%] or −4.7 [−6.3 to −3.1 mmol/mol]; P < .001). Five patients in the 
conventional treatment group and 1 patient in the continuous glucose monitoring group 
had severe hypoglycemia. The trial revealed that among patients with inadequately 
controlled type 1 diabetes treated with MSIs , the use of continuous glucose monitoring 
compared with conventional treatment for 26 weeks resulted in lower HbA1c. 
Heinemann  etal conducted  the HypoDE study which was a 6-month, multicentre, 
open-label, parallel, randomised controlled trial done at 12 diabetes practices in 
Germany in which eligible participants had type 1 diabetes and a history of impaired 
hypoglycaemia awareness or severe hypoglycaemia during the previous year, all 
participants wore a masked rtCGM system for 28 days and were then randomly 

 14 
assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the 
control group (continuing with SMBG). Block randomisation with 1:1 allocation was 
done centrally and control participants wore a masked rtCGM system during the follow-
up phase (weeks 22-26). The primary outcome was the baseline-adjusted number of 
hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the 
follow-up phase. In the study, 149 participants were randomly assigned (n=74 to the 
control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 
in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic 
events per 28 days among participants in the rtCGM group was reduced from 10·8 (SD 
10·0) to 3·5 (4·7); reductions among control participants were negligible (from 14·4 
[12·4] to 13·7 [11·6]). Incidence of hypoglycaemic events decreased by 72% for 
participants in the rtCGM group (incidence rate ratio 0·28 [95% CI 0·20-0·39], 
p<0·0001), thus CGMS reduced number of hypoglycemic events in T1D (16). 
Ólafsdóttir etal performed evaluations from the GOLD randomized trial, an open-label 
multicenter crossover randomized clinical trial (n = 161) over 69 weeks comparing 
CGM to SMBG in persons with T1D treated with MSI and they used masked CGM and 
the hypoglycemia confidence questionnaire for evaluations. It was found that time with 
nocturnal hypoglycemia, glucose levels <70 mg/dL was reduced by 48% (10.2 vs. 19.6 
min each night, P < 0.001) and glucose levels <54 mg/dL by 65%. (3.1 vs. 8.9 min, P 
< 0.001). For the corresponding glucose cutoffs, daytime hypoglycemia was reduced 
by 40% (29 vs. 49 min, P < 0.001) and 54% (8 vs. 18 min., P < 0.001), respectively. 
Compared with SMBG, CGM use improved hypoglycemia-related confidence in social 
situations (P = 0.016) and confidence in more broadly avoiding serious problems due 
to hypoglycemia (P = 0.0020). Persons also reported greater confidence in detecting 
and responding to decreasing blood glucose levels (thereby avoiding hypoglycemia) 

 15 
during CGM use (P = 0.0033) and indicated greater conviction that they could more 
freely live their lives despite the risk of hypoglycemia (P = 0.022). Hence, CGM 
reduced time in both nocturnal and daytime hypoglycemia in persons with T1D  treated 
with MSI and improved hypoglycemia-related confidence, especially in social 
situations, thus contributing to greater well-being and quality of life(28). 
Charleer etal conducted a 24-month, prospective, observational cohort study which 
followed 441 adults with insulin pumps receiving full reimbursement for rtCGM and 
42% had IAH. The primary end point was evolution of HbA1c, with secondary end 
points change in acute hypoglycemia complications, diabetes-related work 
absenteeism, and quality of life scores. Additionally, they evaluated whether people 
could achieve glycemic consensus targets during follow-up. It was found that after 24 
months, HbA1c remained significantly lower compared with baseline (7.64% [60 
mmol/mol] vs. 7.37% [57 mmol/mol], P < 0.0001) and  sustained benefits were also 
observed for the score on the hypoglycemia fear survey and hypoglycemia-related acute 
complications irrespective of hypoglycemia awareness level. Moreover, people with 
IAH had the strongest improvement, especially for severe hypoglycemia (862 events in 
the year before vs. 119 events per 100 patient-years in the 2nd year, P < 0.0001) and  
over 24 months, more people were able to meet hypoglycemia consensus targets at the 
expense of slightly fewer people achieving hyperglycemia consensus targets. 
Furthermore, the number of people with HbA1c <7% (<53 mmol/mol) without severe 
hypoglycemia events more than doubled (11.0% vs. 25.4%, P < 0.0001). Thus, use of 
rtCGM led to sustained improvements in hypoglycemia-related glucose control over 24 
months and lower fear of hypoglycemia, fewer acute hypoglycemia-related events, and 
fewer diabetes-related days off from work were observed, particularly in those with 
IAH(29). 

 16 
Dicembrini etal conducted  analysis of RCTs comparing CGM or FGM with SMBG, 
with a duration of at least 12 weeks. The principal endpoint was HbA1c at the end of 
the trial and a secondary endpoint was severe hypoglycemia. Mean and 95% confidence 
intervals for HbA1c and Mantel–Haenzel odds ratio [MH-OR] for severe hypoglycemia 
were calculated, using random effect models and a sensitivity analysis was also 
performed using fixed effect models. In addition, the following secondary endpoints 
were explored, using the same methods: time in range, health-related quality of life, 
and treatment satisfaction. Separate analyses were performed for trials comparing CGM 
with SMBG, and those comparing CGM + CSII and SMBG + MSI. It was found that 
CGM was associated with a significantly lower HbA1c at endpoint in comparison with 
SMBG (− 0.24 [− 0.34,− 0.13]%); and a significantly lower risk of severe 
hypoglycemia than SMBG, treatment satisfaction and quality of life were not measured, 
or not reported, in the majority of studies and  FGM showed a significant reduction in 
the incidence of mild hypoglycemia and an increased treatment satisfaction, but no 
significant results are shown in HbA1c. Also, CGM + CSII in comparison with SMBG 
+ MSI was associated with a significant reduction in HbA1c. Thus, CGMS compared 
to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with 
type 1 diabetes and even greater reduction in HbA1c with  CGMS + CSII than with 
SMBG(30). 
From above studies we conclude that CGMS is better than SMBG in T1D patients with 
regards to improvement in HbA1c and decrease in number of hypoglycemic events. 
 
 
 
 

 17 
Rt-CGMS vs is-CGMS in T1D 
There are very few studies comparing rt-CGMS vs is-CGMS in T1D patients some of 
which are as follows: 
Reddy et 
al(2017) 
(31) 
40adults T1DM with 
problematic 
hypoglycemia  
Improvement in time spent in hypoglycemia 
with rtCGM compared to isCGM 
IHART-
CGM 
extension 
(2018) 
(32) 
rtCGM vs isCGM in 
40 T1D after 8 and 
16 weeks , switching 
from is-CMS to rt-
CGM  
Significant reduction in percentage time in 
hypoglycemia (<3.0 mmol/L) in the group 
switching from flash to rt-CGMS (from 5.0 
[3.7–8.6]% to 0.8 [0.4–1.9]%, P = 0.0001), 
and  time in target range (3.9–10 mmol/L) 
increased in the flash group after switching 
to rt-CGMS (60.0 [54.5–67.8] vs. 67.4 
[56.3–72.4], P = 0.02) No reduction in TBR 
with isCGMS (11.9% baseline to 11.9% at 8 
weeks ) compared to rtCGMS (8.8% to 
6.2%). 
CORRIDA 
RCT (2020) 
(26) 
rtCGMS vs 
isCGMS, 60 T1DM 
Time in Hypoglycemia during exercise was 
lower in rtCGM(6.8% vs 11.4%, p=0.018)& 
during home phase(5.3% vs 7.3%,p=0.035). 
 
Reddy etal assessed the impact of CGMS and FGM in a high-risk group of people with 
T1D by a randomized, non-masked parallel group study using a multiple-dose insulin-
injection regimen with inclusion of patients with a Gold score of ≥ 4 or recent severe 
hypoglycaemia. Following 2 weeks of blinded CGM, they were randomly assigned 40 

 18 
T1D patients to CGM (Dexcom G5) or flash glucose monitoring (Abbott Freestyle 
Libre) for 8 weeks. The primary outcome was the difference in time spent in 
hypoglycaemia (below 3.3 mmol/l) from baseline to endpoint with CGM versus flash 
glucose monitoring. In this trial,  40 participants were randomized to CGM (n = 20) or 
flash glucose monitoring (n = 20), the participants (24 men, 16 women) had a median 
(IQR) age of 49.6 (37.5–63.5) years, duration of diabetes of 30.0 (21.0–36.5) years and 
HbA1c of 56 (48–63) mmol/mol [7.3 (6.5–7.8)%].The baseline median percentage time 
< 3.3 mmol/l was 4.5% in the CGM group and 6.7% in the flash glucose monitoring. 
At the end-point, the percentage time < 3.3 mmol/l was 2.4%, and 6.8% respectively 
(median between group difference -4.3%, P = 0.006) hence the time spent in 
hypoglycaemia at all thresholds, and hypoglycaemia fear, were different between 
groups, favouring CGM. They concluded that CGM more effectively reduces time 
spent in hypoglycaemia in people with Type 1 diabetes and impaired awareness of 
hypoglycaemia compared with flash glucose monitoring. 
The I HART CGM study showed that real-time continuous glucose monitoring (RT-
CGM) has greater beneficial impact on hypoglycemia than intermittent flash glucose 
monitoring (flash) in adults with type1 diabetes (T1D) at high risk. Reddy etal then 
evaluated the impact of continuing RT-CGM or switching from flash to RT-CGM for 
another 8 weeks as an extension of I HART CGM study. It was a prospective 
randomized parallel group study with an extension phase, there was a 2-week run-in 
with blinded CGM, after which participants were randomized to either rt-CGM or flash 
for 8 weeks. All participants were then given the option to continue with rt-CGM for 
another 8 weeks. Glycemic outcomes at 8 weeks are compared with the 16-week 
endpoint. Finally, 40 adults with T1D on MSIs and with IAH or a recent episode of 
severe hypoglycemia were included (40% female, median [IQR] age 49.5 [37.5–63.5] 

 19 
years, with a diabetes duration of 30.0 [21.0–36.5] years, HbA1c 56 [48–63] mmol/mol, 
and Gold Score 5[4–5]), of whom 36 completed the final 16-week extension. It was 
shown that there was a significant reduction in percentage time in hypoglycemia (<3.0 
mmol/L) in the group switching from flash to rt-CGMS (from 5.0 [3.7–8.6]% to 0.8 
[0.4–1.9]%, P = 0.0001), whereas no change was observed in the rt-CGMS group 
continuing with the additional 8 weeks of rt-CGMS (1.3 [0.4–2.8] vs. 1.3 [0.8–2.5], P 
= 0.82) amd  time in target range (3.9–10 mmol/L) increased in the flash group after 
switching to rt-CGMS (60.0 [54.5–67.8] vs. 67.4 [56.3–72.4], P = 0.02) and remained 
the same in the RT-CGM group that continued with RT-CGM (65.9 [54.1–74.8] vs. 
64.9 [49.2–73.9], P = 0.64). It was concluded that switching from flash to RT-CGM 
has a significant beneficial impact on hypoglycemia outcomes and that continued use 
of RT-CGM maintains hypoglycemia risk benefit in this high-risk population. 
Hasaga etal  conducted a trial  recently to compare the efficacy of real-time and 
intermittently scanned continuous glucose monitoring (rtCGM and isCGM, 
respectively) in maintaining optimal glycemic control in T1D patients with normal 
hypoglycemia awareness (Gold score <4). They used rtCGM (Guardian Connect 
Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) 
and in the subsequent 4 weeks at home (home phase). Primary end points were time in 
hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9–10.0 mmol/L [70–
180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 
days to check for bias between the different sensors used by the rtCGM and isCGM 
systems. In total, 60 adults with T1D (mean age 38613 years; A1C 62612 mmol/mol 
[7.861.1%]) were randomized to rtCGM (n =30) or isCGM (n=30). It was found that 
percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among 
rtCGM versus isCGM participants in the exercise phase (6.865.5% vs. 11.468.6%, 

 20 
respectively; P50.018) and during the home phase (5.362.5% vs. 7.36 4.4%, 
respectively; P 5 0.035) with hypoglycemia differences being most notable during the 
night. Also, rtCGM participants spent more time in range (3.9–10 mmol/L [70–180 
mg/dL]) than isCGM participants throughout both the exercise (78.5610.2% vs. 
69.7616%, respectively; P50.0149) and home (75.669.7% vs. 67.4 6 17.8%, 
respectively; P 5 0.0339) phases. Final conclusion was that rtCGM was superior to 
isCGM in reducing hypoglycemia and improving time in range in adults with T1D with 
normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during 
exercise and in daily diabetes self management. 
To the best of our knowledge only one study comparing rt-CGMS vs is-CGMS is there 
in T1D adult patients in individuals with normal hypoglycemic awareness. With 
multiple limtations like no cross-over and no assessment of change in HbA1c and 
CGMS device being continuously worn which is not practical in our scenario. 
The current thesis protocol supersedes on these limitations. 
HYPOTHESIS 
rt-CGMS is better than is-CGMS for short term effect on glycemic control which also 
will be translated into longer term glycemic control as reflected by improvement in 
HbA1c. 
We are postulating that by application of CGMS for 2 weeks glycemic patterns of 
individual patients will be identified and the education provided in this regard will 
change the insight of the individual towards his disease which will culminate in better 
longer term blood glucose control and already previous studies have shown that glucose 
readings from the most recent 14 days correlate strongly with 3 months of mean blood 
glucose, time in ranges, and hyperglycemia metrics (33,34). 
 

 21 
 
Primary objective: 
To study the effects of rtCGM vs isCGM on: 
• Reduction in HbA1c (at the end of 3 months). 
Secondary objectives: 
• Reduction in glycemic variability. 
• Reduction in hypoglycemic events in adults with Type-1 Diabetes. 
• Reduction in Fructosamine (at the end of 2 weeks). 
• Quality of life as assessed by QOLID (Nagpal etal) Questionnaire 
 
 
 
 
 
 
 
 
 
 

 22 
 
MATERIALS AND METHODS 
1. Study design: Open label crossover RCT with 3 arms 
2. Sample size:  Sample size of 17 is requires for a power of 80% to detect 0.5% 
change in HbA1c between both groups with an alpha of 0.05, Assuming 10% 
attrition in each group 20 patients will be recruited in all rt-CGMS and is-CGMS 
and 40 in SMBG arms. 
3. Subjects: Patients attending Endocrinology OPD at PGIMER Chandigarh 
4. Study Period: I5th June 2023 to 15th February 2024(last enrolment on 15th 
August 2023) and last follow up on 15th February 2024. 
5. Study Center: PGIMER, Chandigarh 
6. Study Population: Patients who fulfill inclusion and exclusion criteria will be 
recruited from OPD. 
Inclusion criteria :  
• 
Adolescents and adults 15 years with Type-1 Diabetes mellitus defined 
by any of the following; 
• Diabetic Ketoacidosis or ketonemia or ketonuria at diagnosis 
with insulin dependence for survival since diagnosis OR 
• 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; 

 23 
• 
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. 
 
 
 
 
 
 
 
 
 
 

 24 
EXCLUSION CRITERIA: 
• 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%; 
• DKA in previous 3 months; 
•  Severe Non proliferative Diabetic retinopathy/Proliferative DR/Macular 
edema; 
• Pregnancy; 
• Lactation; 
• Willing to become pregnant during study; 
• Requiring MRI for any existing condition; 
• Any chronic illness. 
 
     
 
 
 
  
 
 
 
 

 25 
 
METHODOLOGY 
Participants meeting inclusion criteria will be randomized to rt-CGMS, is-CGMS and 
SMBG arms. Randomization will be done using computer generated random number 
list. Blocks of patients with HbA1c 8%-10% and 10%-12% will be distributed equally 
in all 3 groups. 
Sample Size: With a 1:1:2randomization ratio in 3 arms with sample size of 20:20:40 
participants in each groups will be required. 
Initial training of 2 weeks for all enrolled patients in each of 3 groups about the disease 
itself, ICR, ISF, carbohydrate counting and bolus dose adjustment based on these 
parameters will be done, for premeal boluses.Only those patients will be enrolled who 
are using Lispro/Aspart/Glulisine for their diabetes control. All adults enrolled in 
the rt-CGM group will be placed on rt-CGM Medtronic CGMS for 2 weeks and finger-
prick blood glucose will also be monitored by glucometer (SMBG) 3 times on day 1 
and then at least 2 times per day with proper record of time. All patients will use same 
glucometer for SMBG. Physical exercise of at least 30 mins aerobic activity will be 
required in all patients. 
After a week a new Medtronic CGMS will be applied as per the manufacturer 
recommendation. Those randomized into is-CGM will be placed on Abott Libre Flash 
system for 2 weeks. A 3rd group on SMBG will also be there (doing SMBG 4 times a 

 26 
day- Before breakfast, Before Lunch, and Before Dinner and post meal (after any one 
meal on rotational basis) and 7 point profile once a week on Sunday).  
During this 2 week intervention phase all the patients will be monitored daily 
telephonically along with  once in a week follow-up visit. 
Fructosamine assay will be repeated after 2 weeks in rt-CGMS and is-CGMS groups 
and glycemic control compared. Thereafter the 3 groups shall use SMBG for 
monitoring glycemic status as in SMBG group and HbA1c will be repeated at the end 
of 3 months.  
CGMS metrics of the 2 weeks (TBR, TIR ,TAR etc) will be compared in both groups 
as per ADA recommendations and those with <70% data available will be kept on a 
new device. 
At the end of 3 months direct cross-over of rt-CGMS group to new is-CGMS group and 
is-CGMS group to new rt-CGMS group will be done and again fructosamine assay shall 

 27 
be done at the baseline and at the end of 2 weeks. Thereafter, all the 3 groups shall use 
same glucometer for SMBGtill the end of 6 months where HbA1c will be estimated. 
Hence, for each participant total 6 months of data will be recorded. Individuals will act 
as their own control thereby removing confounding factors in analysis 
be done at the baseline and at the end of 2 weeks. Thereafter, all the 3 groups shall use 
same glucometer for SMBG till the end of 6 months where HbA1c will be estimated. 
Hence, for each participant total 6 months of data will be recorded. Individuals will act 
as their own control thereby removing confounding factors in analysis.  
All these insulins and CGM systems are a part of routine standard care in 
management of Type-1 Diabetes Mellitus as endorsed by American Diabetic 
Association in 2022. 
 
 
 
 
 
 
 
 

 28 
 
 
 
 
 
 

 29 
FLOW CHART OF STUDY PROTOCOL 
 
 
 
 
 
 
 
 
 
 
 
Type 1 DM (Age15 years, HbA1c 
8%-12%) 
Patient evaluated for inclusion v/s exclusion criteria 
Inclusion criteria 
met 
Opted in to study 
DDonot meet 
criteria 
Opted out of study 
Baseline investigations -CBC LFT KFT Lipid profile IgAttG ,Thyroid profile, Urine spot protein 
creatinine ratio and Fundus examination 

 30 
 
 
Patients enrolled in the study
2 weeks training
Rt-CGMS
20
Is-CGMS
20
SMBG
40
• 
Insulin injection 
techniques 
• 
Self Monitoring 
of Blood Glucose 
• 
Carbohydrate 
counting 
• 
Insulin 
Carbohydrate 
Ratio and Insulin 
Sensitivity Factor 
Fructosamine assay at the end of training phase 

 31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
rt-CGMS for initial 2 
weeks  
is-CGMS for initial 2 weeks 
SMBG 4 times a day plus 7 
point profile once a week 
for 2 weeks 
Fructosamine assay and CGMS metrics of  2 weeks are  
compared 
SMBG 4 times a day: FBG, AFTER MEAL, BL, BD and 7 point plasma glucose profile once a week till 3 months. 
HbA1c 
2 weeks 
T=0 Start of CGMS 
3 months 

 32 
 
 
 
 
 
 
 
 
v 
 
 
 
 
 
 
 
 
rt-CGMS group 
is-CGMS group 
SMBG group 
New rt-CGMS group 
New is-CGMS group 
SMBG group 
Fructosamine at baseline and at 2 weeks, Comparison of CGMS 
metrics of 14 days done. 
3 months 
At 6 months 
HbA1c 
3 months 
2 weeks 
6 months 

 33 
 
 
 
 
 
 
 

 
34 
 
 
OUTCOME VARIABLES TO BE STUDIED 
• Glycemic variability as assed by CGMS 
• Daily average insulin requirement per kg body weight 
• Fructosamine assay after 2 weeks in rt-CGMS group and is-CGMS group and HbA1c in each 
of the 3 groups at end of 3 and 6 months respectively; 
• Number of hypoglycemic events especially nocturnal and exercise related events; 
• Any complications related to CGM; 
• Quality of Life by QOLID (Nagpal etal) Questionnaire. 
 
Statistical Analysis: 
Statistical analysis will be performed according to the results obtained from parameters. Discrete 
categorical data will be represented in the form of either a number or a percentage (%), continuous 
data, assumed to be normally distributed, will be  written as  either in the form of its mean and 
standard deviation or in the form of its median and  interquartile range, as per the requirement. The 
normality of quantitative data will be checked by measures of Kolmogorov-Smirnov tests of 
normality.  ANOVA or Mann Whitney U test will be applied to compare 3 groups at a time 
depending upon the normality of the data.  Proportions will be compared using Chi square or Fisher’s 
exact test, depending on their applicability for 3 groups. All the statistical tests will be two-sided and 
will be performed at a significance level of P<0.05. Analysis will be conducted using IBM SPSS 
STATISTICS (version 22.0) 
 
 
 
 
33 

 
35 
 
ETHICAL JUSTIFICATION 
 
Following ethical considerations will be adhered to during the study: 
1. Patients will be enrolled in the study after fully informed written consent has been taken. The 
patient will have right to quit the study at any point in time during the study and no 
compulsion will be exerted on them. 
2. Patient will be informed about the aim and method of the study, investigations that will be 
conducted on him/her, possible adverse effects associated with the treatment modality under 
study even after he/she has signed the consent and he/she will be excluded from the study. 
3. The patient, whether or not enrolled in the study will receive treatment as per the standard 
protocol followed in the Department of Endocrinology PGIMER, Chandigarh.  
4. The planned study involves blood collection (10 ml) by venipuncture from T2D patients. The 
blood sample will be used for biochemical tests, haematological tests and Hormonal analysis.  
5. Detailed education regarding CGM, methods of insertion, use and linking to smartphone 
wherever available will be provided. 
6. Signs and symptoms of hypoglycemia will be thoroughly explained and measures to correct 
it shall be taught to the patients. 
7. Confidentiality of data collected from contribution source or individual will be maintained. 
8. The study will be conducted following the principles of Declaration of Helsinki and Good 
clinical Practice laid down by Indian Council of Medical Research. 
 
 
 
 
 
 
 
 
 
 
  
 
34 

 
36 
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QOLID QUESTIONNAIRE 
Role Limitation Due to Physical Health 
1. 
How often do you miss your work because of your diabetes ? 
 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
2. 
A person with diabetes has the requirement of adhering to a schedule for 
eating and taking regular medication. How often does this affect your work 
? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
3. 
How often does diabetes affect your efficiency at Work ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
4. 
How often do you find diabetes limiting your social life ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
5. 
To what extent do you avoid traveling (business tour, holiday, general 
outings) because of your diabetes ? 
A lot 
Highly 
Little 
Very little 
Not at all 
1 
2 
3 
4 
5 
 
6. 
Compared to others of your age are your social activities (visiting 
friends/partying) 
limited 
because 
of 
your 
diabetes? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
53

 
 
Physical Endurance 
1. 
How often in last three months has your overall health problems limited 
the kind of vigorous activities you can do like lifting heavy bags/objects, 
running, skipping, jumping. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
2. 
How often in last three months has your overall health problems limited 
the kind of moderate activities you can do like moving a table, carrying 
groceries or utensils. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
3. 
How often in last three months has your overall health problems limited 
you from walking uphill or climbing 1-2 floors. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
4. 
How often in last three months has your overall health problems limited 
you from walking 1-2 km at a stretch. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
5. 
How often in last three months has your overall health problems limited 
from bending, squatting, or turning. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
6. 
How often in last three months has your overall health problems limited 
you from eating, dressing, bathing, or using the toilet. 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
54

 
 
General Health 
1. 
In general would you say your health. 
Poor 
Fair 
Good 
Very good 
Excellent 
1 
2 
3 
4 
5 
 
2. 
How well are you able to concentrate in everything like working, driving, 
reading etc. ? 
Not at all 
A little 
Moderate 
Very Much 
An 
extreme 
Amount 
1 
2 
3 
4 
5 
 
3. 
How many times in the past three months have you had fatigue/felt very 
tired ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
55

 
 
Treatment Satisfaction 
The following set of questions would enable us to know how satisfied are you 
with your treatment for diabetes. Please tick any one option. 
1. 
How satisfied are you with your current diabetes treatment ? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
 
2. 
How satisfied are you with amount of time it takes to manage your diabetes 
? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
 
3. 
How satisfied are you with the amount of time you spend getting regular 
checkups (once in 3 months) ? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
 
2. A person with diabetes needs to exercise for 35-45 min, 4 times a week. 
Keeping this in mind how satisfied are you with the time you spend 
exercising ? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
56

 
 
Financial Worries 
 
The following set of questions will help us know how your diabetes has affected 
your or your family's finances. Please tick any one option. 
1. 
What do you think about the cost involved in your management of 
diabetes ? 
Very 
expensive 
Little expensive 
Reasonable 
Not at all 
expensive 
1 
2 
3 
4 
 
2. 
To what extent has your priority of expenditure shifted towards diabetes 
management ? 
A lot 
Highly 
Little 
Very Little 
Not at all 
1 
2 
3 
4 
5 
 
3. 
To what extent has your family budget got affected by the expenses 
related to the management of diabetes ? 
A lot 
Highly 
Little 
Very Little 
Not at all 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
57

 
 
Symptom Botherness 
 
1. 
How many times in the past three months have you had thirst/dry mouth ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
2. 
How many times in the past three months have you felt excessive hunger ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
3. 
How many times in the past three months have you had frequent urination 
related to diabetes management ? 
Always 
Frequency 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
4. 
To what extent has your diabetes limited your expenditure on other 
aspects of life (Moving, outings, parties etc.)? 
A lot 
Highly 
Little 
Very Little 
Not at all 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
58

 
 
Emotional/Mental Health 
1. 
How satisfied are you with yourself ? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
 
2. 
How satisfied are you with your personal relationships (family, friends, 
relatives and known tos) 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
3. 
How satisfied are you with the emotional support you get from your friends 
and family ? 
Very 
dissatisfied 
Moderately 
dissatisfied 
Neither 
satisfied nor 
dissatisfied 
Moderately 
satisfied 
Very 
satisfied 
1 
2 
3 
4 
5 
 
4. 
How often are you discouraged by your health problems ? 
Always 
Frequently 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
5. 
All people want to fulfill certain roles and lead their lives in a purposeful 
manner. To what extent do you feel that you have been able to lead your 
life in the same way ? 
Not at all 
A little 
Moderate 
Very much 
An extreme 
amount 
1 
2 
3 
4 
5 
 
 
 
59

 
 
Diet Satisfaction 
Diabetes demands a little modification in diet, thus the 
following set of questions would help us know how much 
satisfied you are with modifications in your diet ? 
(For 
participants 
who 
have 
been 
advised 
some 
dietary 
modification/counseling) 
 
1. 
How often do you feel because of your diabetes a 
restriction in choosing your food when eating out ? 
Always 
Frequently 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
2. 
As you have diabetes, how much choice od you feel 
you have in eating your meals or snacks away from 
home e.g. if you go in a party and there is a buffet 
where there are also a lot of fried snacks and desserts 
would you be able to make enough choice ? 
No choice 
Very little 
Little 
Enough 
A lot 
1 
2 
3 
4 
5 
 
3. 
How often do you eat the food items that you 
shouldn't, in order to hide the fact that you are having 
diabetes. 
Always 
Frequently 
Often 
Sometimes 
Never 
1 
2 
3 
4 
5 
 
 
 
60 
 
 
 
 

 
 
 
Informed Consent Form (ICF) 
 
Study Title: 
“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”. 
Study Number (if any): 
 
Subject’s Initials: _______________ 
 
Subject’s Name:_______________ 
 
Date of Birth / Age: _________________ 
 
 
Participant'
s initial  
 
 
1. I confirm that I have read and understood the information sheet 
dated _ _ _ _ for the above study and have had the opportunity to 
ask questions. 
 
 
2. I understand that my participation in the study is voluntary and 
that I am      free to withdraw at any time, without giving any 
reason, without my      medical care or legal rights being affected. 
  
 
3.   I understand that the Sponsor of the clinical trial, others 
working on the      Sponsor’s behalf, the Ethics Committee and 
the regulatory authorities          will not need my permission to 
look at my health records both in respect        of the current study 
and any further research that may be conducted in          relation 
to it, even if I withdraw from the trial. I agree to this access.        
However, I understand that my identity will not be revealed in 
any          information released to third parties or published. 
 
4. I agree not to restrict the use of any data or results that arise from 
this     study provided such a use is only for scientific purpose(s)  
 

 
5. I agree to take part in the above study  
 
 
 
 
Signature (or Thumb impression) of the Subject/Legally Acceptable 
Representative:_____________ 
 
Date: _____/_____/______ 
 
Signatory’s Name: ________________________________________ 
 
Signature of the Investigator: ____________________________ 
 
Date:_____/_____/______ 
 
Study Investigator’s Name: ____________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
सूचित सहमतत फॉम (आईसीएफ) 
 
अध्ययन का शीर्मक: "टाइप 1 डायबिटीज मेलिटस वािे ककशोरों और 
वयस्कों में रुक-रुक कर स्कैन ककए गए सीजीएमएस के साथ रीयि-टाइम 
सीजीएमएस की तुिना: एक ओपन िेिि रैंडमाइज्ड कंट्रोि क्रॉस ओवर 
स्टडी"। 
अध्ययन संख्या (यदि कोई हो): 
ववर्य के आद्याक्षर: _______________ 
ववर्य का नाम:_______________ 
जन्म ततचथ / आयु: _________________ 
 
प्रततभागी का आद्याक्षर 
 
1. मैं पुष्टट करता हूं कक मैंने उपरोक्त अध्ययन के लिए सूिना पत्र दिनांक_ 
_ _ को पढ़ और समझ लिया है और मुझे प्रश्न पूछने का अवसर लमिा है। 
 
2. मैं समझता हूं कक अध्ययन में मेरी भागीिारी स्वैष्छछक है और यह कक 
मैं ककसी भी समय, बिना कोई कारण िताए, अपनी चिककत्सा िेखभाि या 
कानूनी अचिकारों को प्रभाववत ककए बिना वापस िेने के लिए स्वतंत्र हूं। 
 
 
3. मैं समझता हूं कक नैिातनक परीक्षण के प्रायोजक, प्रायोजक की ओर से 
काम करने वािे अन्य िोग, आिार सलमतत और तनयामक प्राचिकरण 
वतममान अध्ययन और ककसी भी अन्य शोि के संिंि में मेरे स्वास््य 
ररकॉडम को िेखने के लिए मेरी अनुमतत की आवश्यकता नहीं होगी इसके 
संिंि में, भिे ही मैं मुकिमे से हट जाऊं। मैं इस पहुंि से सहमत हूं। 

 
हािांकक, मैं समझता हूं कक मेरी पहिान ककसी में भी जादहर नहीं की 
जाएगी- तृतीय पक्षों को जारी की गई जानकारी या प्रकालशत। 
 
4. मैं इस अध्ययन से उत्पन्न होने वािे ककसी भी डेटा या पररणाम के 
उपयोग को प्रततिंचित नहीं करने के लिए सहमत हूं, िशते ऐसा उपयोग 
केवि वैज्ञातनक उद्िेश्य के लिए हो। 
 
5. मैं उपरोक्त अध्ययन में भाग िेने के लिए सहमत हूं 
 
 
 
 
ववर्य/कानूनी रूप से स्वीकायम प्रतततनचि के हस्ताक्षर (या अंगूठे का 
तनशान):___________ 
तारीख: _____/_____/______ 
हस्ताक्षरकताम का नाम: ________________________________________ 
अन्वेर्क के हस्ताक्षर: ____________________________ 
तारीख:_____/_____/______ 
अध्ययन अन्वेर्क का नाम: ________________________________________ 
 
 
 
 
 
 
 
 
 
 

 
ਸੂਚਿਤ ਸਚਿਮਤੀ ਫਾਰਮ (ICF) 
 
ਅਚਿਐਨ ਦਾ ਚਸਰਲੇਖ: “ਟਾਈਪ 1 ਡਾਇਬਟੀਜ਼ ਮਲੇਟਸ ਵਾਲੇ ਚਿਸ਼ੋਰਾਂ ਅਤੇ ਬਾਲਗਾਂ 
ਚਵਿੱਿ ਰੁਿ-ਰੁਿ ਿੇ ਸਿੈਨ ਿੀਤੇ CGMS ਨਾਲ ਅਸਲ-ਸਮੇਂ ਦੇ CGMS ਦੀ ਤੁਲਨਾ: ਇਿੱਿ 
ਓਪਨ ਲੇਬਲ ਰੈਂਡਮਾਈਜ਼ਡ ਿੰਟਰ਼ੋਲ ਿਰਾਸ ਓਵਰ ਸਟਿੱਡੀ”। 
ਅਚਿਐਨ ਨੰਬਰ (ਜੇ ਿ਼ੋਈ ਿੈ): 
ਚਵਸੇ ਦੇ ਸੁਰੂਆਤੀ ਅਿੱਖਰ: _______________ 
ਚਵਸੇ ਦਾ ਨਾਮ: _______________ 
ਜਨਮ ਚਮਤੀ / ਉਮਰ: ____________________ 
 
ਭਾਗੀਦਾਰ ਦਾ ਸੁਰੂਆਤੀ 
 
 
1. ਮੈਂ ਪੁਸਟੀ ਿਰਦਾ/ਿਰਦੀ ਿਾਂ ਚਿ ਮੈਂ ਉਪਰ਼ੋਿਤ ਅਚਿਐਨ ਲਈ ਚਮਤੀ _ _ _ _ ਦੀ 
ਜਾਣਿਾਰੀ ਸੀਟ ਨੂੰ ਪੜ੍ਹ ਅਤੇ ਸਮਝ ਚਲਆ ਿੈ ਅਤੇ ਮੈਨੂੰ ਸਵਾਲ ਪੁਿੱਛਣ ਦਾ ਮੌਿਾ ਚਮਚਲਆ 
ਿੈ। 
 
2. ਮੈਂ ਸਮਝਦਾ/ਸਮਝਦੀ ਿਾਂ ਚਿ ਅਚਿਐਨ ਚਵਿੱਿ ਮੇਰੀ ਭਾਗੀਦਾਰੀ ਸਵੈਇਿੱਛਤ ਿੈ ਅਤੇ ਇਿ 
ਚਿ ਮੈਂ ਚਿਸੇ ਵੀ ਸਮੇਂ, ਚਬਨਾਂ ਿ਼ੋਈ ਿਾਰਨ ਦਿੱਸੇ, ਮੇਰੀ ਡਾਿਟਰੀ ਦੇਖਭਾਲ ਜਾਂ ਿਾਨੂੰਨੀ 
ਅਚਿਿਾਰਾਂ ਨੂੰ ਪਰਭਾਚਵਤ ਿੀਤੇ ਚਬਨਾਂ ਵਾਪਸ ਲੈਣ ਲਈ ਸੁਤੰਤਰ ਿਾਂ। 
 
 
3. ਮੈਂ ਸਮਝਦਾ/ਸਮਝਦੀ ਿਾਂ ਚਿ ਿਲੀਚਨਿਲ ਟਰਾਇਲ ਦੇ ਸਪਾਂਸਰ, ਸਪਾਂਸਰ ਦੀ ਤਰਫੋਂ ਿੰਮ 
ਿਰ ਰਿੇ ਿ਼ੋਰ ਲ਼ੋਿ, ਐਚਿਿਸ ਿਮੇਟੀ ਅਤੇ ਰੈਗੂਲੇਟਰੀ ਅਿਾਰਟੀਆਾਂ ਮੌਜੂਦਾ ਅਚਿਐਨ ਅਤੇ 
ਿ਼ੋਰ ਚਿਸੇ ਵੀ ਖ਼ੋਜ ਦੇ ਸਬੰਿ ਚਵਿੱਿ ਮੇਰੇ ਚਸਿਤ ਚਰਿਾਰਡਾਂ ਨੂੰ ਦੇਖਣ ਲਈ ਮੇਰੀ ਇਜਾਜ਼ਤ ਦੀ 
ਲ਼ੋੜ੍ ਨਿੀਾਂ ਿ਼ੋਵੇਗੀ ਜ਼ੋ ਇਸ ਚਵਿੱਿ ਿੀਤੀ ਜਾ ਸਿਦੀ ਿੈ ਇਸ ਨਾਲ ਸਬੰਿਤ, ਭਾਵੇਂ ਮੈਂ ਮੁਿੱਦਮੇ 
ਤੋਂ ਚਪਿੱਛੇ ਿਟ ਜਾਂਦਾ ਿਾਂ। ਮੈਂ ਇਸ ਪਿੁੰਿ ਲਈ ਸਚਿਮਤ ਿਾਂ। 
ਿਾਲਾਂਚਿ, ਮੈਂ ਸਮਝਦਾ ਿਾਂ ਚਿ ਮੇਰੀ ਪਛਾਣ ਚਿਸੇ ਵੀ ਰੂਪ ਚਵਿੱਿ ਪਰਗਟ ਨਿੀਾਂ ਿੀਤੀ ਜਾਵੇਗੀ 
ਤੀਜੀ ਚਿਰ ਨੂੰ ਜਾਰੀ ਿੀਤੀ ਜਾਂ ਪਰਿਾਚਸਤ ਿੀਤੀ ਗਈ ਜਾਣਿਾਰੀ। 

 
 
4. ਮੈਂ ਇਸ ਅਚਿਐਨ ਤੋਂ ਪੈਦਾ ਿ਼ੋਣ ਵਾਲੇ ਚਿਸੇ ਵੀ ਡੇਟਾ ਜਾਂ ਨਤੀਚਜਆਾਂ ਦੀ ਵਰਤੋਂ 'ਤੇ ਪਾਬੰਦੀ 
ਨਾ ਲਗਾਉਣ ਲਈ ਸਚਿਮਤ ਿਾਂ ਬਸਰਤੇ ਚਿ ਅਚਜਿੀ ਵਰਤੋਂ ਿੇਵਲ ਚਵਚਗਆਨਿ ਉਦੇਸਾਂ 
ਲਈ ਿ਼ੋਵੇ। 
 
5. ਮੈਂ ਉਪਰ਼ੋਿਤ ਅਚਿਐਨ ਚਵਿੱਿ ਚਿੱਸਾ ਲੈਣ ਲਈ ਸਚਿਮਤ ਿਾਂ 
 
ਚਵਸੇ/ਿਾਨੂੰਨੀ ਤੌਰ 'ਤੇ ਸਵੀਿਾਰਯ਼ੋਗ ਪਰਤੀਚਨਿੀ ਦੇ ਦਸਤਖਤ (ਜਾਂ ਅੰਗੂਠੇ ਦਾ ਚਨਸਾਨ): 
_____________ 
ਤਾਰੀਖ਼: _____/_____/______ 
ਿਸਤਾਖਰ ਿਰਨ ਵਾਲੇ ਦਾ ਨਾਮ: _______________________________________ 
ਜਾਂਿਿਰਤਾ ਦੇ ਦਸਤਖਤ: ______________________________ 
ਤਾਰੀਖ਼:_____/_____/______ 
ਅਚਿਐਨ ਜਾਂਿਿਰਤਾ ਦਾ ਨਾਮ: ____________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
PATIENT INFORMATION SHEET 

 
PRINCIPAL INVESTIGATOR: Dr. Sanjay Kumar Bhadada  
Phone Number: +919876602448 
Study title: 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  
Invitation: You are being invited to take part in a research study. Before 
you decide it is important for you to understand why the research is being 
done and what it will involve. Please take time to read following 
information carefully and discuss with your friends, relatives or your 
family doctor if you wish to. Ask us if there is anything that is not clear or 
you would like to know more about the study.  
1. What is the purpose of the study?  
To compare the efficacy of rt-CGM vs is-CGM on improvement in 
glycemic profile at end of 3 months and 6 months in T1DM patients.  
2. What is the expected duration of the study?  
Expected duration for the study is 6 months  
3. Why have I been chosen? 
You have been chosen as a patient suffering from Type 1 Diabetes 
Mellitus. 
4. What are the benefits from this research? 
After participation in this study , you would be able to do 
carbohydrate counting and adjust insulin doses according to your 
meal content and pre-meal blood glucose values which will improve 
your meal flexibility without any compromise with your blood 
glucose control. Moreover, there would be 3 groups in this study and 
if you are randomized into one of the two CGMS groups, CGMS 
will be provided to you and by this technology your meal patterns 
and blood glucose fluctuations will be analysed and your insulin 
dosages will be modified accordingly. If you are randomized to 
SMBG group, you will be under close monitoring and supervision 
of a specialist and your insulin dosages would be modified as per the 

 
standard of care. Irrespective of randomization in any of the groups, 
your blood glucose control is expected to improve during this study. 
Through this research we are hypothesizing that only 2 week use of 
CGMS is enough to uncover your glycemic patterns, which is cost 
effective and the behavioural changes and therapeutic changes made 
in your treatment regime by the analysis of 2 week CGMS report 
will have an impact on your blood glucose control as reflected in 
your HbA1c at 3 months. Most of the studies have used continuous 
application of CGMS which is not practical in our country. 
5. Do I have to take part?  
It is up to you to decide whether or not to take part? If you decide to 
take part you will be given this information sheet to keep and will be 
asked to sign a consent form. If you decide to take part you are still free 
to withdraw at any time without giving a reason. Even if you decide, 
not to take part in this study, this will not affect the standard of care you 
receive.  
6. What will happen to me if I take part? 
You will have to sign consent. You will be physically examined. You 
have to give blood samples periodically and you can be kept in either 
of rt-CGMS or is-CGMS groups. Standard treatment of T1D will be 
provided irrespective of randomization in any group.  
7. What are the alternatives available to you? 
This is not a drug trial and we are only monitoring your blood glucose 
levels by CGMS, in case you don’t want to participate in this trial you 
can use Self monitoring of blood glucose by multiple finger pricks as is 
the standard of care for management of type 1 diabetes.  
8. What are the possible risks of taking part in study?  
There is almost no risk involved in this study because only blood 
samples and CGMS and SMBG for glucose profile will be done which 
is usual standard of care in T1D. You shall be under strict monitoring 
throughout our study  
9. What will be the treatment schedule in this study? 

 
The study will include 80 participants  and you will be randomized 
to rt-CGMS, is-CGMS or SMBG arm using computer generated 
random number list. Initial  training  of  2  weeks  for  all  enrolled  
patients  in  each  of  3  groups  about  the disease itself,  ICR, ISF,  
carbohydrate counting and bolus dose adjustment based on these  
parameters  will  be  done,  for  premeal  boluses.  If you are 
randomized into the rt-CGM group will be placed on rt-CGM 
Medtronic CGMS for 2  weeks  ;if in is-CGM group, u will be 
provided  Abott Libre Flash system for 2 weeks and if in SMBG 
group, u will monitor blood glucose by multiple finger pricks at least 
4 times a day- Before breakfast, Before Lunch, and Before Dinner 
and post meal (after any one meal on rotational basis) on weekdays 
and 7 point profile once a week on Sunday. After 3 months, you will 
be switched to other CGMS group if u were in any of the CGMS 
groups, however, if  you were in SMBG group, you will continue to 
be in that group till the end of this study. 
10. How much blood will be taken for investigations and at what time 
points? 
2ml of blood will be taken after the end of training phase (2 weeks), 
then after the end of CGMS device application  (4 weeks) and at 
three months and three and a half   month  and finally at 6 months 2 
weeks (total 8 ml blood will be taken for each patient over a period 
of 6 months)”(total four times in CGMS group). In SMBG group 
2ml of blood will be taken after the end of training phase (2 weeks), 
at 3 months and 2 weeks  and finally at 6 months 2 weeks (total 6 
ml of blood over a period of 6 months for each patient) ;in total 3 
times during the study. 
11. Will my talking part of this study kept confidential? 
All information collected about you during the course study will be kept 
confidential.  
12. What compensation and or treatments are available in case of trial 
related injury?  
The intervention we are doing here is application of Continuous 
Glucose Monitoring System for 14 days which is the standard of care 
for Type-1 Diabetes Mellitus as advocated by different guidelines 
(ref ADA 2022), all patients will receive the standard of care 
treatment (Insulin for type 1 diabetes) and no novel treatment is 

 
being introduced. Henceforth, it is not expected that any patient will 
develop any adverse event because of the particular intervention in 
the study as we are monitoring their glucose level only. However if 
any patient develops hypoglycemia including severe hypoglycemia 
(which may otherwise happen in any individual patient of type 1 
diabetes on insulin therapy) will be managed as per routine clinical 
care including hospital admission if needed.  
13. Are the participants paid to take part in this study? 
The participants will be reimbursed for their extra study related 
visits as per the norms. Apart from this no extra money will be 
provided to them. There will be no additional costs to be borne by 
the participants for participation in this study. 
14. What will be done with the results of study? 
Results of the research may be published. We assure you that you 
will not be identified by name in any report/publication.  
15. Who is organizing the research? 
Department of Endocrinology, PGIMER, Chandigarh are organizing 
this research  
16. Who has reviewed this study? 
           Ethics committee of the institution will review the study.  
17.  Whom can I contact if for any query or grievance? 
You can contact the following:  
1. Principal Investigator- Dr. Sanjay Kumar Bhadada, Head of 
Department, Department of Endocrinology Room number 1, 
Ground floor, Nehru Hospital Extension, PGIMER, Chandigarh-
160012, Phone Number: +919876602448  
2. Institute Ethics Committee, PGIMER - 6th floor PN Chuttani Block, 
Chandigarh- 160012, Phone number: 0172-2755266.  
 
रोगी सूचना पत्र 

 
मुख्य अन्वेषक: डॉ. संजय कुमार भडाडा 
 
फोन नंबर: +919876602448 
अध्ययन शीर्षक: ग्लाइसेमिक ननयंत्रण िें रीयल-टाइि सीजीएिएस बनाि 
आंतरानयक रूप से स्कैन ककए गए सीजीएिएस और टाइप 1 िधुिेह िेमलटस 
रोगगयों के सिूह िें पररवतषनशीलता: क्ललननकल ननयंत्रण अध्ययन पर एक खुला 
लेबल अध्ययन 
आिंत्रण: आपको एक शोध अध्ययन िें भाग लेने के मलए आिंत्रत्रत ककया जा रहा 
है। ननणषय लेने से पहले आपके मलए यह सिझना िहत्वपूणष है कक शोध लयों ककया 
जा रहा है और इसिें लया शामिल होगा। कृपया ननम्नमलखखत जानकारी को ध्यान 
से पढ़ने के मलए सिय ननकालें और यदि आप चाहें तो अपने िोस्तों, ररश्तेिारों या 
अपने पररवार के डॉलटर से चचाष करें। हिसे पूछें कक लया कुछ ऐसा है जो स्पष्ट नहीं 
है या आप अध्ययन के बारे िें अगधक जानना चाहते हैं। 
 
1. अध्ययन का उद्िेश्य लया है?  
T1D रोगगयों िें 3 िहीने के अंत िें ग्लाइसेमिक प्रोफाइल िें सुधार पर RT-CGM 
बनाि is-CGM की प्रभावकाररता की तुलना करना 
 
2. अध्ययन की अपेक्षित अवगध लया है? 
अध्ययन के मलए अपेक्षित अवगध 6 िहीने है 
 

 
3. िुझे लयों चुना गया है: आपको टाइप 1 डायत्रबटीज िेमलटस से पीड़ित रोगी के 
रूप िें चुना गया है। 
4. इस शोि से क्या िाभ हैं? 
 
इस अध्ययन में भाग िेने के िाि, आप अपने भोजन की मात्रा और भोजन से पहिे 
के रक्त ग्िूकोज मूल्यों के अनुसार कािोहाइड्रेट की चगनती और इंसुलिन खुराक 
को समायोष्जत करने में सक्षम होंगे, जो आपके रक्त ग्िूकोज तनयंत्रण के साथ 
ककसी भी तरह का समझौता ककए बिना आपके भोजन के ििीिेपन में सुिार 
करेगा। इसके अिावा, इस अध्ययन में 3 समूह होंगे और यदि आपको िो 
सीजीएमएस समूहों में से एक में यादृष्छछक ककया जाता है, तो आपको सीजीएमएस 
प्रिान ककया जाएगा और इस तकनीक द्वारा आपके भोजन के पैटनम और रक्त 
शकमरा के उतार-िढ़ाव का ववश्िेर्ण ककया जाएगा और आपके इंसुलिन की खुराक 
को संशोचित ककया जाएगा। इसलिए। यदि आपको एसएमिीजी समूह में 
यादृष्छछक रूप से शालमि ककया गया है, तो आप एक ववशेर्ज्ञ की करीिी तनगरानी 
और पयमवेक्षण के अिीन होंगे और आपकी इंसुलिन खुराक को िेखभाि के मानक 
के अनुसार संशोचित ककया जाएगा। ककसी भी समूह में यादृष्छछकीकरण के 
िावजूि, इस अध्ययन के िौरान आपके रक्त शकमरा तनयंत्रण में सुिार होने की 
उम्मीि है। 
इस शोि के माध्यम से हम पररकल्पना कर रहे हैं कक सीजीएमएस का केवि 2 
सप्ताह का उपयोग आपके ग्िाइसेलमक पैटनम को उजागर करने के लिए पयामप्त है, 
जो कक िागत प्रभावी है और 2 सप्ताह की सीजीएमएस ररपोटम के ववश्िेर्ण से 
आपके उपिार व्यवस्था में ककए गए व्यवहाररक पररवतमन और उपिारात्मक 
पररवतमन पर प्रभाव पडेगा। 3 महीने में आपके रक्त शकमरा तनयंत्रण को आपके 
एििीए1सी में िशामया गया है। अचिकांश अध्ययनों में सीजीएमएस के तनरंतर 
अनुप्रयोग का उपयोग ककया गया है जो हमारे िेश में व्यावहाररक नहीं है। 
5. क्या मुझे भाग िेना है? 
यह आपको तय करना है कक भाग िेना है या नहीं? यदि आप भाग िेने का तनणमय 
िेते हैं तो आपको यह सूिना पत्र रखने के लिए दिया जाएगा और सहमतत फॉम पर 

 
हस्ताक्षर करने के लिए कहा जाएगा। यदि आप भाग िेने का तनणमय िेते हैं, ति भी 
आप बिना कोई कारण िताए ककसी भी समय अपना नाम वापस िेने के लिए स्वतंत्र 
हैं। यदि आप इस अध्ययन में भाग न िेने का तनणमय भी िेते हैं, तो इससे आपको 
प्राप्त होने वािी िेखभाि के स्तर पर कोई प्रभाव नहीं पडेगा। 
6. यदि मैं भाग िेता हूूँ तो मेरा क्या होगा? 
आपको सहमतत पर हस्ताक्षर करना होगा। आपकी शारीररक जांि की जाएगी। 
आपको समय-समय पर रक्त के नमूने िेने होते हैं और आपको आरटी-
सीजीएमएस या आईएस-सीजीएमएस समूहों में से ककसी एक में रखा जा सकता 
है। ककसी भी समूह में रैंडमाइजेशन के िावजूि टी1डी का मानक उपिार प्रिान 
ककया जाएगा। 
7. आपके पास क्या ववकल्प उपिब्ि हैं? 
यह कोई िवा परीक्षण नहीं है और हम केवि सीजीएमएस द्वारा आपके रक्त शकमरा 
के स्तर की तनगरानी कर रहे हैं, यदि आप इस परीक्षण में भाग नहीं िेना िाहते हैं 
तो आप कई अंगुलियों की िुभन से रक्त ग्िूकोज की स्व तनगरानी का उपयोग कर 
सकते हैं जैसा कक प्रिंिन के लिए िेखभाि का मानक है टाइप 1 मिुमेह का। 
8. अध्ययन में भाग िेने के संभाववत जोखखम क्या हैं? 
इस अध्ययन में िगभग कोई जोखखम शालमि नहीं है क्योंकक ग्िूकोज प्रोफाइि के 
लिए केवि रक्त के नमूने और सीजीएमएस और एसएमिीजी ककए जाएंगे जो कक 
टी1डी में िेखभाि का सामान्य मानक है। हमारे अध्ययन के िौरान आप कडी 
तनगरानी में रहेंगे 
 
9. इस अध्ययन में उपिार कायमक्रम क्या होगा? 
अध्ययन में 80 प्रततभाचगयों को शालमि ककया जाएगा और आपको कंप्यूटर जतनत 
यादृष्छछक संख्या सूिी का उपयोग करके rt-CGMS, is-CGMS या SMBG शाखा में 
यादृष्छछक ककया जाएगा। िीमारी के िारे में 3 समूहों में से प्रत्येक में सभी 
नामांककत रोचगयों के लिए 2 सप्ताह का प्रारंलभक प्रलशक्षण, इन मापिंडों के आिार 
पर आईसीआर, आईएसएफ, कािोहाइड्रेट की चगनती और िोिस खुराक 
समायोजन, भोजन से पहिे के िोिस के लिए ककया जाएगा। यदि आपको आरटी-
सीजीएम समूह में रैंडमाइज ककया जाता है तो आपको आरटी-सीजीएम मेडट्रॉतनक 

 
सीजीएमएस पर 2 सप्ताह के लिए रखा जाएगा; दिन में कम से कम 4 िार कई 
अंगुलियों से ब्िड ग्िूकोज- नाश्ते से पहिे, िोपहर के भोजन से पहिे, और रात के 
खाने से पहिे और भोजन के िाि (रोटेशनि आिार पर ककसी एक भोजन के िाि) 
सप्ताह के दिनों में और रवववार को सप्ताह में एक िार 7 बिंिु प्रोफाइि। 3 महीने 
के िाि, यदि आप ककसी सीजीएमएस समूह में थे, तो आपको अन्य सीजीएमएस 
समूह में ििि दिया जाएगा, हािांकक, यदि आप एसएमिीजी समूह में थे, तो आप 
इस अध्ययन के अंत तक उस समूह में िने रहेंगे। 
 
10. जांि के लिए ककतना और ककस समय पर ब्िड लिया जाएगा? 
प्रलशक्षण िरण (2 सप्ताह) के अंत के िाि 2 एमएि रक्त लिया जाएगा, कफर 
सीजीएमएस डडवाइस एष्प्िकेशन के अंत के िाि (4 सप्ताह) और तीन महीने और 
साढ़े तीन महीने और अंत में 6 महीने 2 सप्ताह (कुि 8 एमएि) 6 महीने की अवचि 
में प्रत्येक रोगी के लिए रक्त लिया जाएगा)” (सीजीएमएस समूह में कुि िार िार)। 
एसएमिीजी समूह में 2 एमएि रक्त प्रलशक्षण िरण (2 सप्ताह) के अंत के िाि, 3 
महीने और 2 सप्ताह और अंत में 6 महीने 2 सप्ताह (प्रत्येक रोगी के लिए 6 महीने 
की अवचि में कुि 6 एमएि रक्त) लिया जाएगा; अध्ययन के िौरान कुि 3 िार। 
 
11. क्या इस अध्ययन के मेरे िोिने वािे दहस्से को गोपनीय रखा जाएगा? 
पाठ्यक्रम अध्ययन के िौरान आपके िारे में एकत्र की गई सभी जानकारी गोपनीय 
रखी जाएगी। 
 
12. परीक्षण संिंिी िोट के मामिे में क्या मुआवजा और/या उपिार उपिब्ि हैं? 
हम यहां जो हस्तक्षेप कर रहे हैं, वह 14 दिनों के लिए तनरंतर ग्िूकोज मॉतनटररंग 
लसस्टम का अनुप्रयोग है जो कक टाइप -1 डायबिटीज मेलिटस की िेखभाि का 
मानक है, जैसा कक ववलभन्न दिशातनिेशों (रेफरी एडीए 2022) द्वारा समचथमत है, 
सभी रोचगयों को मानक िेखभाि उपिार (इंसुलिन) प्राप्त होगा। टाइप 1 मिुमेह 
के लिए) और कोई नया उपिार पेश नहीं ककया जा रहा है। अि से, यह उम्मीि नहीं 
की जाती है कक अध्ययन में ववशेर् हस्तक्षेप के कारण कोई भी रोगी ककसी प्रततकूि 
घटना का ववकास करेगा क्योंकक हम केवि उनके ग्िूकोज स्तर की तनगरानी कर 

 
रहे हैं। हािांकक, यदि ककसी मरीज में गंभीर हाइपोग्िाइसीलमया सदहत 
हाइपोग्िाइसीलमया ववकलसत हो जाता है (जो इंसुलिन थेरेपी पर टाइप 1 मिुमेह 
के ककसी भी व्यष्क्तगत रोगी में अन्यथा हो सकता है) को अस्पताि में प्रवेश सदहत 
तनयलमत नैिातनक िेखभाि के अनुसार प्रिंचित ककया जाएगा। 
 
13. क्या प्रततभाचगयों को इस अध्ययन में भाग िेने के लिए भुगतान ककया जाता 
है? 
प्रततभाचगयों को मानिंडों के अनुसार उनकी अततररक्त अध्ययन संिंिी यात्राओं के 
लिए प्रततपूततम की जाएगी। इसके अिावा उन्हें कोई अततररक्त पैसा नहीं दिया 
जाएगा। इस अध्ययन में भाग िेने के लिए प्रततभाचगयों द्वारा कोई अततररक्त 
िागत वहन नहीं की जाएगी। 
 
14. अध्ययन के पररणामों का क्या ककया जाएगा? 
शोि के पररणाम प्रकालशत ककए जा सकते हैं। हम आपको ववश्वास दििाते हैं कक 
ककसी भी ररपोटम/प्रकाशन में आपके नाम से आपकी पहिान नहीं होगी। 
 
15. शोि का आयोजन कौन कर रहा है? 
एंडोक्राइनोिॉजी ववभाग, पीजीआईएमईआर, िंडीगढ़ इस शोि का आयोजन कर 
रहा है 
 
16. इस अध्ययन की समीक्षा ककसने की है? 
      संस्था की एचथक्स कमेटी अध्ययन की समीक्षा करेगी। 
 
17. ककसी प्रश्न या लशकायत के लिए मैं ककससे संपकम कर सकता हूं? 
आप तनम्नलिखखत से संपकम कर सकते हैं: 
1. प्रिान अन्वेर्क- डॉ. संजय कुमार भिािा, ववभागाध्यक्ष, एंडोक्राइनोिॉजी 
ववभाग, कमरा नंिर 1, ग्राउंड फ्िोर, नेहरू हॉष्स्पटि एक्सटेंशन, 
पीजीआईएमईआर, िंडीगढ़-160012, फोन नंिर: +919876602448 
 

 
2. संस्थान आिार सलमतत, पीजीआईएमईआर - 6वीं मंष्जि पीएन िुट्टानी 
ब्िॉक, िंडीगढ़- 160012, फोन नंिर: 0172-2755266। 
ਮਰੀਜ਼ ਜਾਣਕਾਰੀ ਸੀਟ 
ਮ ੁੱਖ ਜਾਂਚਕਰਤਾ: ਸੰਜੇ ਿੁਮਾਰ ਭਿੱਦਾ, ਡਾ 
 
ਫੋਨ ਨੰਬਰ: +919876602448 
ਅਧਿਐਨ ਧਿਰਲੇਖ: ਧਕਿਮ 1 ਡਾਇਆਧਿਟੀਜ਼ ਮੈਲੀਟਿ ਦੇ ਮਰੀਜ਼ਾ਼ਾਂ ਦੇ ਇੱਕ ਿਮੂਹ ਧ ੱਚ 
ਗਲਾਈਿੀਧਮਕ ਕੰਟਰੋਲ ਅਤੇ ਪਧਰ ਰਤਨਸੀਲਤਾ ਧ ੱਚ ਰੁਕ-ਰੁਕ ਕੇ ਿਕੈਨ ਕੀਤੇ CGMS: 
ਇੱਕ ਖੁੱਲਹੇ ਲੇਿਲ  ਾਲਾ ਿੇਤਰਤੀਿ ਕੀਤਾ ਿੱਦਾ: ਤੁਹਾਨੂੰ ਇੱਕ ਖੋਜ ਅਧਿਐਨ ਧ ੱਚ ਭਾਗ 
ਲੈਣ ਲਈ ਿੱਦਾ ਧਦੱਤਾ ਜਾ ਧਰਹਾ ਹੈ। ਇਿਤੋਂ ਪਧਹਲਾ਼ਾਂ ਧਕ ਤੁਿੀ਼ਾਂ ਫੈਿਲਾ ਕਰੋਂ, ਤੁਹਾਡੇ  ਾਿਤੇ 
ਇਹ ਿਮਝਣਾ ਮਹੱਤ ਪੂਰਨ ਹੈ ਧਕ ਖੋਜ ਨੂੰ ਧਕਉ਼ਾਂ ਕੀਤਾ ਜਾ ਧਰਹਾ ਹੈ ਅਤੇ ਇਿ ਧ ੱਚ ਕੀ ਕੁਝ 
ਸਾਮਲ ਹੋ ੇਗਾ। ਧਕਰਪਾ ਕਰਕੇ ਧਨਮਨਧਲਖਤ ਜਾਣਕਾਰੀ ਨੂੰ ਧਿਆਨ ਨਾਲ ਪੜ੍ਹਨ ਲਈ 
ਿਮਾ਼ਾਂ ਲਓ ਅਤੇ ਜੇ ਤੁਿੀ਼ਾਂ ਇੱਛਾ ਕਰਦੇ ਹੋ ਤਾ਼ਾਂ ਆਪਣੇ ਦੋਿਤਾ਼ਾਂ, ਧਰਸਤੇਦਾਰਾ਼ਾਂ ਜਾ਼ਾਂ ਤੁਹਾਡੇ 
ਪਧਰ ਾਰਕ ਡਾਕਟਰ ਨਾਲ ਧ ਚਾਰ- ਟਾ਼ਾਂਦਰਾ ਕਰੋ। ਜੇ ਕੋਈ ਅਧਜਹੀ ਚੀਜ਼ ਹੈ ਜੋ ਤੁਹਾਨੂੰ 
ਿਪੱਸਟ ਨਹੀ਼ਾਂ ਹੈ ਜਾ਼ਾਂ ਜੇ ਤੁਿੀ਼ਾਂ ਅਧਿਐਨ ਿਾਰੇ  ਿੇਰੇ ਜਾਣਨਾ ਚਾਹੋਂਗੇ ਤਾ਼ਾਂ ਿਾਨੂੰ ਪੁੱਛੋ। ਕਰਾਿ 
ਓ ਰ ਕਲੀਧਨਕੀ ਕੰਟਰੋਲ ਅਧਿਐਨ 
1. ਅਧਿਐਨ ਦਾ ਮਕਿਦ ਕੀ ਹੈ? T1D ਮਰੀਜ਼ਾ਼ਾਂ ਧ ੱਚ 3 ਮਹੀਧਨਆ਼ਾਂ ਦੇ ਅੰਤ 'ਤੇ 
ਗਲਾਈਿੀਧਮਕ ਪਰੋਫਾਈਲ ਧ ੱਚ ਿੁਿਾਰ 'ਤੇ rt-CGM ਿਨਾਮ is-CGM ਦੀ ਅਿਰਦਾਇਕਤਾ 
ਦੀ ਤੁਲਨਾ ਕਰਨ ਲਈ 
2. ਅਧਿਐਨ ਦੀ ਉਮੀਦ ਕੀਤੀ ਜਾ਼ਾਂਦੀ ਧਮਆਦ ਕੀ ਹੈ? 
ਅਧਿਐਨ  ਾਿਤੇ ਉਮੀਦ ਕੀਤੀ ਜਾ਼ਾਂਦੀ ਧਮਆਦ 6 ਮਹੀਨੇ ਹੈ 
3. ਮੈਨੂੰ ਧਕਉ਼ਾਂ ਚੁਧਣਆ ਧਗਆ ਹੈ: ਤੁਹਾਨੂੰ ਟਾਈਪ 1 ਡਾਇਧਿਟੀਜ਼ ਮੈਲੀਟਿ ਤੋਂ ਪੀੜ੍ਤ ਮਰੀਜ਼ 
 ਜੋਂ ਚੁਧਣਆ ਧਗਆ ਹੈ। 
4 . ਇਸ ਖ਼ੋਜ ਤੋਂ ਿੀ ਲਾਭ ਿਨ? 

 
ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਭਾਗ ਲੈਣ ਤੋਂ ਬਾਅਦ, ਤੁਸੀਾਂ ਿਾਰਬ਼ੋਿਾਈਡਰੇਟ ਦੀ ਚਗਣਤੀ ਿਰਨ ਦੇ 
ਯ਼ੋਗ ਿ਼ੋਵ਼ੋਗੇ ਅਤੇ ਤੁਿਾਡੀ ਭ਼ੋਜਨ ਸਮਿੱਗਰੀ ਅਤੇ ਭ਼ੋਜਨ ਤੋਂ ਪਚਿਲਾਂ ਦੇ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ 
ਮੁਿੱਲਾਂ ਦੇ ਅਨੁਸਾਰ ਇਨਸੁਚਲਨ ਖੁਰਾਿਾਂ ਨੂੰ ਅਨੁਿੂਚਲਤ ਿਰ ਸਿ਼ੋਗੇ ਜ਼ੋ ਤੁਿਾਡੇ ਖੂਨ ਚਵਿੱਿ 
ਗਲੂਿ਼ੋਜ਼ ਚਨਯੰਤਰਣ ਨਾਲ ਚਿਸੇ ਵੀ ਸਮਝੌਤਾ ਿੀਤੇ ਚਬਨਾਂ ਤੁਿਾਡੇ ਭ਼ੋਜਨ ਦੀ ਲਿਿਤਾ ਚਵਿੱਿ 
ਸੁਿਾਰ ਿਰੇਗਾ। ਇਸ ਤੋਂ ਇਲਾਵਾ, ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ 3 ਸਮੂਿ ਿ਼ੋਣਗੇ ਅਤੇ ਜੇਿਰ ਤੁਸੀਾਂ ਦ਼ੋ 
CGMS ਸਮੂਿਾਂ ਚਵਿੱਿੋਂ ਇਿੱਿ ਚਵਿੱਿ ਬੇਤਰਤੀਬ ਿ਼ੋ ਜਾਂਦੇ ਿ਼ੋ, ਤਾਂ ਤੁਿਾਨੂੰ CGMS ਪਰਦਾਨ ਿੀਤਾ 
ਜਾਵੇਗਾ ਅਤੇ ਇਸ ਤਿਨਾਲ਼ੋਜੀ ਦੁਆਰਾ ਤੁਿਾਡੇ ਭ਼ੋਜਨ ਦੇ ਪੈਟਰਨ ਅਤੇ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ 
ਦੇ ਉਤਰਾਅ-ਿੜ੍ਹਾਅ ਦਾ ਚਵਸਲੇਸਣ ਿੀਤਾ ਜਾਵੇਗਾ ਅਤੇ ਤੁਿਾਡੀ ਇਨਸੁਚਲਨ ਦੀਆਾਂ ਖੁਰਾਿਾਂ 
ਨੂੰ ਸ਼ੋਚਿਆ ਜਾਵੇਗਾ। ਉਸ ਅਨੁਸਾਰ। ਜੇਿਰ ਤੁਸੀਾਂ SMBG ਸਮੂਿ ਚਵਿੱਿ ਬੇਤਰਤੀਬ ਿ਼ੋ ਗਏ 
ਿ਼ੋ, ਤਾਂ ਤੁਸੀਾਂ ਇਿੱਿ ਮਾਿਰ ਦੀ ਨਜ਼ਦੀਿੀ ਚਨਗਰਾਨੀ ਅਤੇ ਚਨਗਰਾਨੀ ਿੇਠ ਿ਼ੋਵ਼ੋਗੇ ਅਤੇ ਤੁਿਾਡੀ 
ਇਨਸੁਚਲਨ ਦੀਆਾਂ ਖੁਰਾਿਾਂ ਨੂੰ ਦੇਖਭਾਲ ਦੇ ਚਮਆਰ ਅਨੁਸਾਰ ਸ਼ੋਚਿਆ ਜਾਵੇਗਾ। ਚਿਸੇ ਵੀ 
ਸਮੂਿ ਚਵਿੱਿ ਬੇਤਰਤੀਬੀ ਿ਼ੋਣ ਦੇ ਬਾਵਜੂਦ, ਇਸ ਅਚਿਐਨ ਦੌਰਾਨ ਤੁਿਾਡੇ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ 
ਚਨਯੰਤਰਣ ਚਵਿੱਿ ਸੁਿਾਰ ਦੀ ਉਮੀਦ ਿੀਤੀ ਜਾਂਦੀ ਿੈ। 
ਇਸ ਖ਼ੋਜ ਦੁਆਰਾ ਅਸੀਾਂ ਇਿ ਅਨੁਮਾਨ ਲਗਾ ਰਿੇ ਿਾਂ ਚਿ CGMS ਦੀ ਚਸਰਫ 2 ਿਫਚਤਆਾਂ 
ਦੀ ਵਰਤੋਂ ਤੁਿਾਡੇ ਗਲਾਈਸੈਚਮਿ ਪੈਟਰਨਾਂ ਨੂੰ ਉਜਾਗਰ ਿਰਨ ਲਈ ਿਾਫੀ ਿੈ, ਜ਼ੋ ਚਿ ਲਾਗਤ 
ਪਰਭਾਵਸਾਲੀ ਿੈ ਅਤੇ 2 ਿਫਚਤਆਾਂ ਦੀ CGMS ਚਰਪ਼ੋਰਟ ਦੇ ਚਵਸਲੇਸਣ ਦੁਆਰਾ ਤੁਿਾਡੇ 
ਇਲਾਜ ਪਰਣਾਲੀ ਚਵਿੱਿ ਿੀਤੇ ਗਏ ਚਵਵਿਾਚਰਿ ਬਦਲਾਅ ਅਤੇ ਉਪਿਾਰਿ ਤਬਦੀਲੀਆਾਂ 'ਤੇ 
ਪਰਭਾਵ ਪਾਏਗੀ। ਤੁਿਾਡੇ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ ਚਨਯੰਤਰਣ ਚਜਵੇਂ ਚਿ ਤੁਿਾਡੇ HbA1c ਚਵਿੱਿ 3 
ਮਿੀਚਨਆਾਂ ਚਵਿੱਿ ਪਰਤੀਚਬੰਬਤ ਿੁੰਦਾ ਿੈ। ਚਜ਼ਆਦਾਤਰ ਅਚਿਐਨਾਂ ਚਵਿੱਿ CGMS ਦੀ ਚਨਰੰਤਰ 
ਵਰਤੋਂ ਿੀਤੀ ਗਈ ਿੈ ਜ਼ੋ ਸਾਡੇ ਦੇਸ ਚਵਿੱਿ ਚਵਿਾਰਿ ਨਿੀਾਂ ਿੈ। 
 
5. ਿੀ ਮੈਨੂੰ ਚਿੱਸਾ ਲੈਣਾ ਪਵੇਗਾ? 
ਇਿ ਤੁਿਾਡੇ 'ਤੇ ਚਨਰਭਰ ਿਰਦਾ ਿੈ ਚਿ ਤੁਸੀਾਂ ਚਿੱਸਾ ਲੈਣਾ ਿੈ ਜਾਂ ਨਿੀਾਂ? ਜੇਿਰ ਤੁਸੀਾਂ ਚਿੱਸਾ 
ਲੈਣ ਦਾ ਫੈਸਲਾ ਿਰਦੇ ਿ਼ੋ ਤਾਂ ਤੁਿਾਨੂੰ ਰਿੱਖਣ ਲਈ ਇਿ ਜਾਣਿਾਰੀ ਸੀਟ ਚਦਿੱਤੀ ਜਾਵੇਗੀ ਅਤੇ 
ਇਿੱਿ ਸਚਿਮਤੀ ਫਾਰਮ 'ਤੇ ਦਸਤਖਤ ਿਰਨ ਲਈ ਚਿਿਾ ਜਾਵੇਗਾ। ਜੇਿਰ ਤੁਸੀਾਂ ਚਿੱਸਾ ਲੈਣ 
ਦਾ ਫੈਸਲਾ ਿਰਦੇ ਿ਼ੋ ਤਾਂ ਤੁਸੀਾਂ ਚਬਨਾਂ ਿਾਰਨ ਦਿੱਸੇ ਚਿਸੇ ਵੀ ਸਮੇਂ ਵਾਪਸ ਲੈਣ ਲਈ ਆਜ਼ਾਦ 
ਿ਼ੋ। ਭਾਵੇਂ ਤੁਸੀਾਂ ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਚਿੱਸਾ ਨਾ ਲੈਣ ਦਾ ਫੈਸਲਾ ਿਰਦੇ ਿ਼ੋ, ਇਿ ਤੁਿਾਨੂੰ ਪਰਾਪਤ 
ਦੇਖਭਾਲ ਦੇ ਚਮਆਰ ਨੂੰ ਪਰਭਾਵਤ ਨਿੀਾਂ ਿਰੇਗਾ। 
 

 
6. ਜੇ ਮੈਂ ਚਿੱਸਾ ਲਵਾਂ ਤਾਂ ਮੇਰੇ ਨਾਲ ਿੀ ਿ਼ੋਵੇਗਾ? 
ਤੁਿਾਨੂੰ ਸਚਿਮਤੀ 'ਤੇ ਦਸਤਖਤ ਿਰਨੇ ਪੈਣਗੇ। ਤੁਿਾਡੀ ਸਰੀਰਿ ਜਾਂਿ ਿੀਤੀ ਜਾਵੇਗੀ। 
ਤੁਿਾਨੂੰ ਸਮੇਂ-ਸਮੇਂ 'ਤੇ ਖੂਨ ਦੇ ਨਮੂਨੇ ਦੇਣੇ ਪੈਂਦੇ ਿਨ ਅਤੇ ਤੁਿਾਨੂੰ rt-CGMS ਜਾਂ is-CGMS 
ਗਰੁਿੱਪਾਂ ਚਵਿੱਿ ਰਿੱਚਖਆ ਜਾ ਸਿਦਾ ਿੈ। T1D ਦਾ ਚਮਆਰੀ ਇਲਾਜ ਚਿਸੇ ਵੀ ਸਮੂਿ ਚਵਿੱਿ 
ਬੇਤਰਤੀਬੇਿਰਨ ਦੀ ਪਰਵਾਿ ਿੀਤੇ ਚਬਨਾਂ ਪਰਦਾਨ ਿੀਤਾ ਜਾਵੇਗਾ। 
 
7. ਤੁਿਾਡੇ ਲਈ ਚਿਿੜ੍ੇ ਚਵਿਲਪ ਉਪਲਬਿ ਿਨ? 
ਇਿ ਇਿੱਿ ਡਰਿੱਗ ਟਰਾਇਲ ਨਿੀਾਂ ਿੈ ਅਤੇ ਅਸੀਾਂ ਚਸਰਫ਼ CGMS ਦੁਆਰਾ ਤੁਿਾਡੇ ਖੂਨ ਚਵਿੱਿ 
ਗਲੂਿ਼ੋਜ਼ ਦੇ ਪਿੱਿਰਾਂ ਦੀ ਚਨਗਰਾਨੀ ਿਰ ਰਿੇ ਿਾਂ, ਜੇਿਰ ਤੁਸੀਾਂ ਇਸ ਟਰਾਇਲ ਚਵਿੱਿ ਚਿੱਸਾ ਨਿੀਾਂ 
ਲੈਣਾ ਿਾਿੁੰਦੇ ਿ਼ੋ ਤਾਂ ਤੁਸੀਾਂ ਮਲਟੀਪਲ ਚਫੰਗਰ ਚਪਰਿਸ ਦੁਆਰਾ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ ਦੀ ਸਵੈ 
ਚਨਗਰਾਨੀ ਦੀ ਵਰਤੋਂ ਿਰ ਸਿਦੇ ਿ਼ੋ ਚਜਵੇਂ ਚਿ ਪਰਬੰਿਨ ਲਈ ਦੇਖਭਾਲ ਦਾ ਚਮਆਰ ਿੈ। ਟਾਈਪ 
1 ਸੂਗਰ ਦੀ. 
 
8. ਅਚਿਐਨ ਚਵਿੱਿ ਚਿੱਸਾ ਲੈਣ ਦੇ ਸੰਭਾਵੀ ਜ਼ੋਖਮ ਿੀ ਿਨ? 
ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਲਗਭਗ ਿ਼ੋਈ ਜ਼ੋਖਮ ਸਾਮਲ ਨਿੀਾਂ ਿੈ ਚਿਉਾਂਚਿ ਚਸਰਫ ਖੂਨ ਦੇ ਨਮੂਨੇ 
ਅਤੇ ਗਲੂਿ਼ੋਜ਼ ਪਰ਼ੋਫਾਈਲ ਲਈ CGMS ਅਤੇ SMBG ਿੀ ਿੀਤੇ ਜਾਣਗੇ ਜ਼ੋ T1D ਚਵਿੱਿ 
ਦੇਖਭਾਲ ਦਾ ਆਮ ਚਮਆਰ ਿੈ। ਸਾਡੇ ਅਚਿਐਨ ਦੌਰਾਨ ਤੁਿਾਡੀ ਸਖ਼ਤ ਚਨਗਰਾਨੀ ਿੀਤੀ 
ਜਾਵੇਗੀ 
9. ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਇਲਾਜ ਦਾ ਸਮਾਂ ਿੀ ਿ਼ੋਵੇਗਾ? 
ਅਚਿਐਨ ਚਵਿੱਿ 80 ਭਾਗੀਦਾਰ ਸਾਮਲ ਿ਼ੋਣਗੇ ਅਤੇ ਤੁਿਾਨੂੰ ਿੰਚਪਊਟਰ ਦੁਆਰਾ ਚਤਆਰ 
ਿੀਤੀ ਬੇਤਰਤੀਬ ਨੰਬਰ ਸੂਿੀ ਦੀ ਵਰਤੋਂ ਿਰਿੇ rt-CGMS, is-CGMS ਜਾਂ SMBG ਆਰਮ 
ਚਵਿੱਿ ਬੇਤਰਤੀਬ ਿੀਤਾ ਜਾਵੇਗਾ। 2 ਿਫਚਤਆਾਂ ਦੀ ਸੁਰੂਆਤੀ ਚਸਖਲਾਈ 3 ਸਮੂਿਾਂ ਚਵਿੱਿੋਂ ਿਰੇਿ 
ਚਵਿੱਿ ਸਾਰੇ ਦਾਖਲ ਮਰੀਜ਼ਾਂ ਲਈ ਚਬਮਾਰੀ ਬਾਰੇ ਖੁਦ, ICR, ISF, ਿਾਰਬ਼ੋਿਾਈਡਰੇਟ ਦੀ 
ਚਗਣਤੀ ਅਤੇ ਇਿਨਾਂ ਮਾਪਦੰਡਾਂ ਦੇ ਅਿਾਰ ਤੇ ਬ਼ੋਲਸ ਖੁਰਾਿ ਦੀ ਚਵਵਸਿਾ ਪਰੀਮੀਅਲ ਬ਼ੋਲਸ 
ਲਈ ਿੀਤੀ ਜਾਵੇਗੀ। ਜੇਿਰ ਤੁਸੀਾਂ rt-CGM ਗਰੁਿੱਪ ਚਵਿੱਿ ਰੈਂਡਮਾਈਜ਼ ਿ਼ੋ ਗਏ ਿ਼ੋ ਤਾਂ ਤੁਿਾਨੂੰ 2 
ਿਫ਼ਚਤਆਾਂ ਲਈ rt-CGM Medtronic CGMS 'ਤੇ ਰਿੱਚਖਆ ਜਾਵੇਗਾ; ਜੇਿਰ CGM ਗਰੁਿੱਪ 
ਚਵਿੱਿ ਿੈ, ਤਾਂ ਤੁਿਾਨੂੰ 2 ਿਫ਼ਚਤਆਾਂ ਲਈ Abott Libre Flash ਚਸਸਟਮ ਚਦਿੱਤਾ ਜਾਵੇਗਾ ਅਤੇ 
ਜੇਿਰ SMBG ਗਰੁਿੱਪ ਚਵਿੱਿ ਿੈ, ਤਾਂ ਤੁਸੀਾਂ ਚਨਗਰਾਨੀ ਿਰ਼ੋਗੇ। ਚਦਨ ਚਵਿੱਿ ਘਿੱਟ਼ੋ-ਘਿੱਟ 4 ਵਾਰ 
ਇਿੱਿ ਤੋਂ ਵਿੱਿ ਉਾਂਗਲਾਂ ਨਾਲ ਖੂਨ ਚਵਿੱਿ ਗਲੂਿ਼ੋਜ਼ - ਨਾਸਤੇ ਤੋਂ ਪਚਿਲਾਂ, ਦੁਪਚਿਰ ਦੇ ਖਾਣੇ ਤੋਂ 

 
ਪਚਿਲਾਂ, ਅਤੇ ਰਾਤ ਦੇ ਖਾਣੇ ਤੋਂ ਪਚਿਲਾਂ ਅਤੇ ਭ਼ੋਜਨ ਤੋਂ ਬਾਅਦ (ਰ਼ੋਟੇਸਨਲ ਆਿਾਰ 'ਤੇ ਚਿਸੇ 
ਵੀ ਇਿੱਿ ਭ਼ੋਜਨ ਤੋਂ ਬਾਅਦ) ਿਫ਼ਤੇ ਦੇ ਚਦਨ ਅਤੇ 7 ਪੁਆਇੰਟ ਪਰ਼ੋਫਾਈਲ ਿਫ਼ਤੇ ਚਵਿੱਿ ਇਿੱਿ ਵਾਰ 
ਐਤਵਾਰ ਨੂੰ। 3 ਮਿੀਚਨਆਾਂ ਬਾਅਦ, ਜੇਿਰ ਤੁਸੀਾਂ ਚਿਸੇ ਵੀ CGMS ਸਮੂਿ ਚਵਿੱਿ ਸੀ, ਤਾਂ ਤੁਿਾਨੂੰ 
ਦੂਜੇ CGMS ਸਮੂਿ ਚਵਿੱਿ ਬਦਲ ਚਦਿੱਤਾ ਜਾਵੇਗਾ, ਿਾਲਾਂਚਿ, ਜੇਿਰ ਤੁਸੀਾਂ SMBG ਸਮੂਿ ਚਵਿੱਿ 
ਸੀ, ਤਾਂ ਤੁਸੀਾਂ ਇਸ ਅਚਿਐਨ ਦੇ ਅੰਤ ਤਿੱਿ ਉਸ ਸਮੂਿ ਚਵਿੱਿ ਬਣੇ ਰਿ਼ੋਗੇ। 
 
10. ਜਾਂਿ ਲਈ ਚਿੰਨਾ ਖੂਨ ਚਲਆ ਜਾਵੇਗਾ ਅਤੇ ਚਿਿੜ੍ੇ ਸਮੇਂ 'ਤੇ ਚਬੰਦੂ ਿਨ? 
ਚਸਖਲਾਈ ਪੜ੍ਾਅ (2 ਿਫ਼ਤੇ) ਦੇ ਅੰਤ ਤੋਂ ਬਾਅਦ 2ml ਖੂਨ ਚਲਆ ਜਾਵੇਗਾ, ਚਫਰ CGMS 
ਚਡਵਾਈਸ ਐਪਲੀਿੇਸਨ (4 ਿਫ਼ਤੇ) ਦੇ ਅੰਤ ਤੋਂ ਬਾਅਦ ਅਤੇ ਚਤੰਨ ਮਿੀਨੇ ਅਤੇ ਸਾਢੇ ਚਤੰਨ 
ਮਿੀਨੇ ਅਤੇ ਅੰਤ ਚਵਿੱਿ 6 ਮਿੀਨੇ 2 ਿਫ਼ਤੇ (ਿੁਿੱਲ 8 ਚਮ.ਲੀ.) ਿਰੇਿ ਮਰੀਜ਼ ਲਈ 6 ਮਿੀਚਨਆਾਂ 
ਦੀ ਚਮਆਦ ਚਵਿੱਿ ਖੂਨ ਚਲਆ ਜਾਵੇਗਾ)” (CGMS ਸਮੂਿ ਚਵਿੱਿ ਿੁਿੱਲ ਿਾਰ ਵਾਰ)। SMBG 
ਗਰੁਿੱਪ ਚਵਿੱਿ ਚਸਖਲਾਈ ਪੜ੍ਾਅ (2 ਿਫ਼ਚਤਆਾਂ) ਦੇ ਅੰਤ ਤੋਂ ਬਾਅਦ, 3 ਮਿੀਨੇ ਅਤੇ 2 ਿਫ਼ਤੇ 
ਅਤੇ ਅੰਤ ਚਵਿੱਿ 6 ਮਿੀਨੇ 2 ਿਫ਼ਤੇ (ਿਰੇਿ ਮਰੀਜ਼ ਲਈ 6 ਮਿੀਚਨਆਾਂ ਦੀ ਚਮਆਦ ਚਵਿੱਿ ਿੁਿੱਲ 
6 ਚਮਲੀਲੀਟਰ ਖੂਨ) ਚਲਆ ਜਾਵੇਗਾ; ਅਚਿਐਨ ਦੌਰਾਨ ਿੁਿੱਲ 3 ਵਾਰ. 
 
11. ਿੀ ਇਸ ਅਚਿਐਨ ਦੇ ਮੇਰੇ ਬ਼ੋਲਣ ਵਾਲੇ ਚਿੱਸੇ ਨੂੰ ਗੁਪਤ ਰਿੱਚਖਆ ਜਾਵੇਗਾ? 
ਿ਼ੋਰਸ ਦੇ ਅਚਿਐਨ ਦੌਰਾਨ ਤੁਿਾਡੇ ਬਾਰੇ ਇਿੱਠੀ ਿੀਤੀ ਗਈ ਸਾਰੀ ਜਾਣਿਾਰੀ ਨੂੰ ਗੁਪਤ 
ਰਿੱਚਖਆ ਜਾਵੇਗਾ। 
 
12. ਮੁਿੱਦਮੇ ਨਾਲ ਸਬੰਿਤ ਸਿੱਟ ਦੇ ਮਾਮਲੇ ਚਵਿੱਿ ਿੀ ਮੁਆਵਜ਼ਾ ਅਤੇ ਜਾਂ ਇਲਾਜ ਉਪਲਬਿ 
ਿਨ? 
ਅਸੀਾਂ ਇਿੱਿੇ ਜ਼ੋ ਦਖਲਅੰਦਾਜ਼ੀ ਿਰ ਰਿੇ ਿਾਂ ਉਿ 14 ਚਦਨਾਂ ਲਈ ਚਨਰੰਤਰ ਗਲੂਿ਼ੋਜ਼ ਚਨਗਰਾਨੀ 
ਪਰਣਾਲੀ ਦੀ ਵਰਤੋਂ ਿੈ ਜ਼ੋ ਚਿ ਟਾਈਪ-1 ਡਾਇਬੀਟੀਜ਼ ਮਲੇਟਸ ਲਈ ਦੇਖਭਾਲ ਦਾ ਚਮਆਰ ਿੈ 
ਚਜਵੇਂ ਚਿ ਵਿੱਖ-ਵਿੱਖ ਚਦਸਾ-ਚਨਰਦੇਸਾਂ (ਰੇਫ ADA 2022) ਦੁਆਰਾ ਵਿਾਲਤ ਿੀਤੀ ਗਈ ਿੈ, 
ਸਾਰੇ ਮਰੀਜ਼ਾਂ ਨੂੰ ਦੇਖਭਾਲ ਦੇ ਇਲਾਜ ਦੇ ਚਮਆਰ (ਇਨਸੁਚਲਨ) ਪਰਾਪਤ ਿ਼ੋਣਗੇ। ਟਾਈਪ 1 
ਸੂਗਰ ਲਈ) ਅਤੇ ਿ਼ੋਈ ਨਵਾਂ ਇਲਾਜ ਪੇਸ ਨਿੀਾਂ ਿੀਤਾ ਜਾ ਚਰਿਾ ਿੈ। ਇਸ ਤੋਂ ਬਾਅਦ, ਇਿ 
ਉਮੀਦ ਨਿੀਾਂ ਿੀਤੀ ਜਾਂਦੀ ਿੈ ਚਿ ਅਚਿਐਨ ਚਵਿ ਚਵਸੇਸ ਦਖਲਅੰਦਾਜ਼ੀ ਦੇ ਿਾਰਨ ਿ਼ੋਈ ਵੀ 
ਮਰੀਜ਼ ਿ਼ੋਈ ਉਲਟ ਘਟਨਾ ਪੈਦਾ ਿਰੇਗਾ ਚਿਉਾਂਚਿ ਅਸੀਾਂ ਚਸਰਫ ਉਨਹਾਂ ਦੇ ਗਲੂਿ਼ੋਜ਼ ਦੇ ਪਿੱਿਰ 
ਦੀ ਚਨਗਰਾਨੀ ਿਰ ਰਿੇ ਿਾਂ। ਿਾਲਾਂਚਿ ਜੇਿਰ ਿ਼ੋਈ ਮਰੀਜ਼ ਗੰਭੀਰ ਿਾਈਪ਼ੋਗਲਾਈਸੀਮੀਆ 

 
(ਜ਼ੋ ਚਿ ਇਨਸੁਚਲਨ ਿੈਰੇਪੀ 'ਤੇ ਟਾਈਪ 1 ਸੂਗਰ ਦੇ ਚਿਸੇ ਵੀ ਚਵਅਿਤੀਗਤ ਮਰੀਜ਼ ਚਵਿੱਿ ਿ਼ੋ 
ਸਿਦਾ ਿੈ) ਸਮੇਤ ਿਾਈਪ਼ੋਗਲਾਈਸੀਮੀਆ ਚਵਿਚਸਤ ਿਰਦਾ ਿੈ, ਤਾਂ ਲ਼ੋੜ੍ ਪੈਣ 'ਤੇ ਿਸਪਤਾਲ 
ਚਵਿੱਿ ਦਾਖਲੇ ਸਮੇਤ ਰੁਟੀਨ ਿਲੀਚਨਿਲ ਦੇਖਭਾਲ ਦੇ ਅਨੁਸਾਰ ਪਰਬੰਿਨ ਿੀਤਾ ਜਾਵੇਗਾ। 
 
13. ਿੀ ਭਾਗੀਦਾਰਾਂ ਨੂੰ ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਚਿੱਸਾ ਲੈਣ ਲਈ ਭੁਗਤਾਨ ਿੀਤਾ ਜਾਂਦਾ ਿੈ? 
ਭਾਗੀਦਾਰਾਂ ਨੂੰ ਚਨਯਮਾਂ ਅਨੁਸਾਰ ਉਿਨਾਂ ਦੇ ਅਚਿਐਨ ਸੰਬੰਿੀ ਵਾਿੂ ਮੁਲਾਿਾਤਾਂ ਲਈ 
ਅਦਾਇਗੀ ਿੀਤੀ ਜਾਵੇਗੀ। ਇਸ ਤੋਂ ਇਲਾਵਾ ਉਨਹਾਂ ਨੂੰ ਿ਼ੋਈ ਵਾਿੂ ਪੈਸਾ ਨਿੀਾਂ ਚਦਿੱਤਾ ਜਾਵੇਗਾ। 
ਇਸ ਅਚਿਐਨ ਚਵਿੱਿ ਭਾਗ ਲੈਣ ਲਈ ਭਾਗੀਦਾਰਾਂ ਦੁਆਰਾ ਿ਼ੋਈ ਵਾਿੂ ਖਰਿਾ ਨਿੀਾਂ ਿੁਿੱਿਣਾ 
ਪਵੇਗਾ। 
 
14. ਅਚਿਐਨ ਦੇ ਨਤੀਚਜਆਾਂ ਨਾਲ ਿੀ ਿੀਤਾ ਜਾਵੇਗਾ? 
ਖ਼ੋਜ ਦੇ ਨਤੀਜੇ ਪਰਿਾਚਸਤ ਿੀਤੇ ਜਾ ਸਿਦੇ ਿਨ। ਅਸੀਾਂ ਤੁਿਾਨੂੰ ਭਰ਼ੋਸਾ ਚਦਵਾਉਾਂਦੇ ਿਾਂ ਚਿ ਚਿਸੇ 
ਵੀ ਚਰਪ਼ੋਰਟ/ਪਰਿਾਸਨ ਚਵਿੱਿ ਤੁਿਾਡੀ ਪਛਾਣ ਨਾਂ ਨਾਲ ਨਿੀਾਂ ਿੀਤੀ ਜਾਵੇਗੀ। 
15. ਖ਼ੋਜ ਦਾ ਆਯ਼ੋਜਨ ਿੌਣ ਿਰ ਚਰਿਾ ਿੈ? 
ਐਾਂਡ਼ੋਿਰੀਨ਼ੋਲ਼ੋਜੀ ਚਵਭਾਗ, ਪੀਜੀਆਈਐਮਈਆਰ, ਿੰਡੀਗੜ੍ਹ ਇਸ ਖ਼ੋਜ ਦਾ ਆਯ਼ੋਜਨ ਿਰ 
ਚਰਿਾ ਿੈ 
 
16. ਇਸ ਅਚਿਐਨ ਦੀ ਸਮੀਚਖਆ ਚਿਸਨੇ ਿੀਤੀ ਿੈ? 
           ਸੰਸਿਾ ਦੀ ਨੈਚਤਿਤਾ ਿਮੇਟੀ ਅਚਿਐਨ ਦੀ ਸਮੀਚਖਆ ਿਰੇਗੀ। 
 
17. ਜੇਿਰ ਚਿਸੇ ਸਵਾਲ ਜਾਂ ਚਸਿਾਇਤ ਲਈ ਮੈਂ ਚਿਸ ਨਾਲ ਸੰਪਰਿ ਿਰ ਸਿਦਾ/ਸਿਦੀ 
ਿਾਂ? 
ਤੁਸੀਾਂ ਿੇਠਾਂ ਚਦਿੱਤੇ ਲ਼ੋਿਾਂ ਨਾਲ ਸੰਪਰਿ ਿਰ ਸਿਦੇ ਿ਼ੋ: 
1. ਚਪਰੰਸੀਪਲ ਇਨਵੈਸਟੀਗੇਟਰ- ਡਾ. ਸੰਜੇ ਿੁਮਾਰ ਭਿੱਦਾ, ਚਵਭਾਗ ਦੇ ਮੁਖੀ, ਐਾਂਡ਼ੋਿਰੀਨ਼ੋਲ਼ੋਜੀ 
ਚਵਭਾਗ ਦਾ ਿਮਰਾ ਨੰਬਰ 1, ਗਰਾਊਾਂਡ ਫਲ਼ੋਰ, ਨਚਿਰੂ ਿਸਪਤਾਲ ਐਿਸਟੈਂਸਨ, 
ਪੀਜੀਆਈਐਮਈਆਰ, ਿੰਡੀਗੜ੍ਹ-160012, ਫ਼ੋਨ ਨੰਬਰ: +919876602448 
 
2. ਇੰਸਟੀਚਿਊਟ ਐਚਿਿਸ ਿਮੇਟੀ, ਪੀ.ਜੀ.ਆਈ.ਐਮ.ਈ.ਆਰ.- 6ਵੀਾਂ ਮੰਚਜ਼ਲ 
ਪੀ.ਐਨ.ਿੁਟਾਨੀ ਬਲਾਿ, ਿੰਡੀਗੜ੍ਹ- 160012, ਫ਼ੋਨ ਨੰਬਰ: 0172-2755266।