Introduction

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent

hyperglycaemia, that may be caused by impaired insulin secretions, resistant to peripheral
insulin actions or both. Type 2 diabetes mellitus (T2DM) accounts for around 90% of all
cases of diabetes. In T2DM, the response to insulin is diminished, resulting in insulin
resistance. At this stage, insulin is ineffective and in response to that, pancreatic β cells will
increase the production of insulin to maintain glucose homeostasis. But overtime, insulin
production will decrease resulting in T2DM.1,2 Glycemic control is the optimal serum glucose
concentration in diabetic patients. The key therapeutic goal for T2DM is to maintain optimal
glycemic control in order to prevent diabetic complications, such as macroangiopathy or
microangiopathy. The American Diabetes Association (ADA) defines good diabetic control at
a cutoff of glycated hemoglobin (Hb1Ac) 7%, whereas the American College of
Endocrinologists set it at 6.5%.3

Blood glucose monitoring helps to identify and monitor patterns of glucose

fluctuations that occurs in response to exercise, diet, medications, and pathophysiological
processes that cause blood glucose fluctuations. Blood glucose level (BGL) monitoring
conducted outside of clinical facilities, such as the home, are often referred to as capillary
blood glucose (CBG) tests. In contrast, blood glucose tests performed at clinical facilities
may include CBG and plasma glucose venous blood tests. 4 Bedside point of care (POC) CBG
still remains standard of care for assessing glycemic control in hospital for insulin therapy
adjustment in the hospital.5

Continuous glucose monitoring (CGM) is a newer method for assessing blood glucose
levels fluctuation. CGM can provide real time glucose monitoring, thus it can detect
hyperglycemia and hypoglycemia as soon as possible before the onset of clinical symptoms
compared to the conventional point of care CBG test or glucose venous tests. Recent
generations of these devices offer improved accuracy, smaller form, extended sensor life, and
new data presentation software for translating data into increasingly useful metrics on various
mobile platforms.6

Many studies are conducted to compare the efficacy of CGM and conventional POC
CBG in detecting blood glucose fluctuations before the onset of clinical symptoms. Recent
studies conducted in hospitalized T2DM treated with basal bolus insulin showed that CGM
has high accuracy compared to POC CBG in detecting blood glucose fluctuations in
hospitalized T2DM.7–9 Based on the results of recent studies, it suggests that CGM may
improve outcomes of hospitalized patients with T2DM with real time glucose monitoring.
However, the results of studies are still inconsistent in reporting the safety and efficacy of
CGM in improving patients outcomes after inpatient insulin therapy. Therefore, we conducted
this systematic review and meta-analysis to synthesize the evidence of safety and efficacy of
CGM in improving patient outcomes and monitoring blood glucose fluctuations compared
with conventional POC CBG measurement.

Materials and Methods

This systematic review and meta-analysis conducted according to Preferred Reporting

Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. 10 A thorough
systematic literature search was carried out using electronical databases such as PubMed,
Europe PMC, ScienceDirect, and Google Scholar. Keywords associated with literature
searching is summarized in Table 1. This systematic review includes randomized controlled
trials (RCT), non-randomized controlled trials, observational studies, pilot studies published
in the last 10 years.

Table 1. Keywords Associated with Literature Searching for Databases.

Databases Search terms

PubMed ("diabetes mellitus, type 2"[MeSH Terms] OR "type 2 diabetes

mellitus"[All Fields]) AND (("Real"[All Fields] AND ("time"[MeSH
Terms] OR "time"[All Fields]) AND ("continuous glucose
monitoring"[MeSH Terms] OR ("continuous"[All Fields] AND
"glucose"[All Fields] AND "monitoring"[All Fields]) OR "continuous
glucose monitoring"[All Fields])) OR (("glucose"[MeSH Terms] OR
"glucose"[All Fields] OR "glucoses"[All Fields] OR "glucose s"[All
Fields]) AND ("telemetry"[MeSH Terms] OR "telemetry"[All Fields]
OR "telemetries"[All Fields]) AND ("system"[All Fields] OR "system
s"[All Fields] OR "systems"[All Fields]))) AND (("point of care
systems"[MeSH Terms] OR ("point of care"[All Fields] AND
"systems"[All Fields]) OR "point of care systems"[All Fields] OR
("point"[All Fields] AND "care"[All Fields]) OR "point of care"[All
Fields]) AND ("blood glucose"[MeSH Terms] OR ("blood"[All Fields]
AND "glucose"[All Fields]) OR "blood glucose"[All Fields]) AND
 ("research design"[MeSH Terms] OR ("research"[All Fields] AND
"design"[All Fields]) OR "research design"[All Fields] OR "test"[All
Fields]))

Europe PMC “Type 2 diabetes mellitus” AND “Real time continuous glucose
monitoring OR Glucose Telemetry System” AND “Point of care blood
glucose test”

ScienceDirect “Type 2 diabetes mellitus” AND “Real time continuous glucose

monitoring OR Glucose Telemetry System” AND “Point of care blood
glucose test”

Google Scholar “Type 2 diabetes mellitus” AND “Real time continuous glucose
monitoring OR Glucose Telemetry System” AND “Point of care blood
glucose test”

In this study, studies associated with the use of real time CGM and POC blood
glucose test that published in English in the last 10 years are included. We exclude studies
with irrelevant outcome measurements, animal or cadaveric studies, review articles, meta-
analyses, case reports, case series, and publications that are not in English. Study selection
and data extraction from published papers were done by two researchers working in pairs
independently. Any disagreements were settled by conversation or by involving the third
researcher through discussions until a consensus was reached. In this study, we performed
quality assessments using Newcastle Ottawa Score (NOS) for observational studies and
JADAD score for RCT. The risk of bias or quality assessment for each study were conducted
by three researchers, with any differences resolved through discussion until a consensus is
being reached. Outcomes measured for this systematic review are glycemic fluctuations that
defined as time in range (TIR) 70-180 mg/dl, hypoglycemia, defined as percentage of time
below range (TBR) <70 mg/dL and <54 mg/dL, hyperglycemia, defined as percentage of time
above range (TAR) > 180 mg/dl and >250 mg/dl, hypoglycemia events per day, nocturnal
hypoglycemia events, and insulin doses.11

For meta-analysis, we used Cochrane Review Manager 5.4 (RevMan 5.4) We

assessed statistical heterogeneity for each study using the standard chi square test (for
heterogeneity, defined as P < 0.1 was considered significant) and I2 statistics. I 2 ≥ 50% was
indicated for substantial heterogeneity. If I 2 ≥ 50%, then the random effect model was used in
pooled analysis, otherwise the fixed effect model was used. For dichotomous outcomes, the
risk differences (RDs) and 95% confidence interval (CI) were calculated, for continuous
outcomes, mean differences (MDs) and 95% confidence interval (CI) were calculated.
Outcomes are considered statistically significant if P < 0.05 in 95% CI.

Results

A total of 6619 studies were obtained from four databases. After removing duplicate
entries and assessing publications based on their titles and abstracts, a total of 6524 articles
were determined to be unfit and are therefore not included in any further research. After
careful consideration, a total of 43 articles were chosen for additional analysis. Out of the 43
publications, a thorough evaluation was performed on their whole texts, leading to the
exclusion of 26 articles. The reasons for exclusion included 1 article with inappropriate
outcome measurement, 3 articles that could not be obtained, and 1 article that was a review
article. Ultimately, 12 papers met the specific criteria for admission.(7,9,9,12–20) Therefore,
these papers were chosen for additional examination, as depicted in Figure 1.
The composition of the study design is as follows: 4 were randomized controlled
trials, 6 were non-randomized controlled trials, and 2 were cohort studies. The characteristics
of the included studies and patient demographics are described in Table 2. A total of 651
patients were included, with a mean age ranging from 53.6 to 72.5 years old and a mean BMI
ranging from 28.5 to 33.6 kg/m2. Most of the patients had diabetes for a mean of 14.54 to 22
years, with average HbA1c values ranging from 7.8 to 9.8 mmol/L on a daily basis, and mean
blood glucose on admission was 167 to 218 mg/dL. On study assessment using the JADAD
RCT and Non-RCT scale, all included clinical trial studies were included in the good quality
category, with the lowest score are 3, and the highest score is 5. The same results were gained
on NOS assessment for the cohort studies, both cohort studies were categorized in the good
category.
The findings of the meta-analysis incorporating data from three studies indicate that
there are no significant advantages of using CGM over POC for monitoring blood glucose
levels.
Discussion

This systematic review aims to the use of CGM and POC CBG testing for detecting
blood glucose fluctuations in T2DM patients. In recent years, the use of CGM is widely used
in hospitalized T2DM patients, because the use of CGM has enabled the monitoring of
glucose levels without fingersticks. In our meta-analysis, it has shown that the odds ratio for
hypoglycemia in TIR 70-180 mg/dl blood glucose is 1.25 (95%CI 0.89-1.76, p 0.19),
therefore it has no significant risk detected for hypoglycemia in both groups. For TBR < 70
mg/dl, the value of OR is 3.4 (95%CI 1.09-10.63, p 0.03) that favors POC blood glucose
testing for detecting hypoglycemia in TBR < 70 mg/dl. Although, it has no statistically
significant results for detecting hypoglycemia in TBR < 54 mg/dl (OR 2.25, 95% CI 0.77-
6.56), it has shown that for TBR < 54 mg/dL, the POC blood glucose testing is 2.25 times
more significant in detecting hypoglycemia in TBR < 5.4 mg/dl than CGM. This study also
shown that no statistically significant results for calculating OR for hyperglycemia detection
in TAR > 180 mg/dl (OR 1.28, 95%CI 0.9-1.82) and TAR > 250 mg/dl (OR 1.21, 95%CI
0.79-1.85).

This systematic review has shown that it has similar reports with the studies
conducted previously that the glycemic fluctuations within TIR 70-180 mg/dl are comparable
between CGM and POC. However, the main difference between the 2 methods was the
ability to detect episodes of hypoglycemia. 7 Bedside POC is the standard of care to assess
glycemic control in the hospital. Diabetes guidelines recommend bedside POC before meals
and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. 12 In
contrast, CGM provides the advantage of measuring interstitial glucose every 5–15 min, thus
providing a comprehensive 24-h glycemic profile, with better assessment of nocturnal and/or
asymptomatic hypoglycemia and pattern recognition after each treatment intervention. Large
studies using CGM have been shown to facilitate and improve diabetes care in insulin-treated
ambulatory patients with T1D and T2D.13

The use of CGM is widely available today in inpatients settings of T2DM because of
several advantages. The CGM devices offer a significant advantage over POC glucose testing
by providing a wealth of time-series glucose data, allowing up to 288 glucose values per day,
revealing temporal trends and patterns in glucose control, and enhancing the detection of
asymptomatic hypoglycemia. CGM also enables patients to set personalized alarms for
glucose levels that surpass or fall below specific thresholds, thereby promoting timely
intervention and providing significant advantages for individuals in the management of
diabetes.3,14 However, some recent studies has discovered the potential limitation of CGM.
The accuracy and precision of CGM had been so far inferior to those of blood glucose meters
for measurement of capillary blood glucose such that there was increased risk of error in the
clinical application of CGM values. Accuracy and precision have improved dramatically. For
a wide range of glucose values, CGM data are accurate enough to use for self-adjustment of
insulin dosage, detection of hypoglycemia, and evaluating response to therapy. Accuracy is
strongly dependent on the glucose level and rate of change of glucose levels.15–18

Although the use of POC CBG still remains gold standard in assessing blood glucose
fluctuations in detecting hypoglycemia, there are some challenges for the patients in
effectively adhering to POC CBG. The assays employed are generally less analytically
sensitive than assays performed in the central laboratory and are often more at risk of
interferences than traditional laboratory tests.19 As an example, POC CBG measurements
have been shown to be affected by hematocrit levels as well as ascorbic acid present in
patients’ blood. POC CBG often employ enzymes for the measurement of glucose that are not
necessarily specific to glucose alone and can be interfered with by other sugars such as
maltose or galactose.20 It often makes patients encounter challenges in effectively adhering to
POC CBG, including the discomfort of regular fingerprick tests, factors like anxiety,
perceptions of diabetes, and vulnerability to complications.21–25

Although we can conduct the systematic review and meta-analysis that provides
evidence of the comparison between CGM and POC CBG in detecting blood glucose
fluctuations and variability in T2DM, this systematic review and meta-analysis still has some
limitations. First, the outcome of the measurement of each studies conducted is still
inconsistent that makes the studies included in meta-analysis is still limited. Second, the
sample size of each included studies is still small, therefore further studies with larger sample
size is needed for more consistent and representing results.

In conclusion, this systematic review and meta-analysis concludes that the use of
CGM is comparable to POC CBG testing in detecting blood glucose fluctuations in T2DM
patients. It has no significant differences in most of the blood glucose fluctuations detection
in T2DM patients, therefore CGM is considered a novel method that can be used to detect
blood glucose fluctuations in inpatient settings comparable to POC CBG. Further large scale,
prospective studies and clinical trials is still needed to compare efficacy of CGM to POC
CBG for the more consistent results in the future.
Table 2. Study and patient characteristics.

Gender Duration of Admission

Sampl HbA1c
Mean Age BMI diabetes BG
No Study ID (year) Country e size mal femal (%), mean
(SD) (kg/m2) (mean ± (mg/dL),
(n) e (n) e (n) ± SD
SD) mean ± SD
1 Powel (2024) USA 45 19 26 52.7 ± 12 NA NA 9,8% ± 1.3 NA
2 Davis G (2023) USA 22 20 2 59±14 31.2 ±8.21 18 ± 15 8.2±1.4 167±21
Spanakis E 33.46 ±
3 USA 162 98 64 56.23 ± 11 14.54 ± 9.4 9.50 ± 2.5
(2022) 10.74 218 ± 110
4 Sweeney (2022) USA 11 8 3 72.5 ± 4.3 30.6 (5.2) NA 7.8% ± 1.2 179 ± 18.7
5 Davis (2021) USA 9 6 3 65.9 ±15.2 33.6± 6.21 NA 7.8± 2.7 NA
6 Baker (2021) USA 10 6 4 59 ± 15 NA NA NA NA
7 Dillman (2021) France 53 41 12 53.6 ± 2.1 28.5±1.11 14.8±1.6 8.8±0.2 NA
8 Davis (2021) USA 218 147 71 60.6 ± 12 33.4 ± 9.10 15.9 ± 10.3 9.1 ± 2.2 203.6 ± 69.8
9 Sing (2020) USA 72 67 5 68.0 ± 10 32.0 ± 8.24 18 ±13.1 8.4 ± 1.8 NA
10 Longo (2021) USA 28 NA NA NA NA NA NA NA
11 Singh (2020) USA 16 12 4 69.1 ± 8.0 32.0 ± 7.11 20.2 ± 9.7 8.0% ± 1.8 168.57 ±22.9
12 Spanakis (2017) USA 5 NA NA 70.8 ± 6.2 33.1 ± 9.32 22 ± 12.9 8.0 ± 0.9 167.5 ±19.6

Table 3. Study assessment

RCT Studies: JADAD RCT Scale

Account of all
Study ID (Year) Randomization Blinding Total Score
patients
Davis G, et al. (2023) 1 1 1 3
Spanakis E, et al (2022) 2 2 1 5
Sweeney, et al (2022) 2 1 1 4
Davis et al (2021) 2 2 1 5
Dillman, et al (2021) 1 1 1 3
Davis, et al (2021) 1 1 1 3
Longo, et al (2021) 2 1 1 4
Sing, et al (2020) 2 2 1 5
Singh, et al (2020) 1 1 1 3
Spanakis, et al (2017) 1 1 1 3

Cohort Studies: NOS scale for cohort studies

Studies Selection Comparability Outcome Total Score
Baker, et al (2021) *** * *** 7
Powel, et al (2024) **** * *** 8
Figure 1. PRISMA diagram depicting the detailed process of studies selection for the systematic review and
meta-analysis.
Figure 2. Forest plot of the odds ratio of patients with POC glucose monitoring vs CGM to have TIR
70-180 mg/dL.

Figure 3. Forest plot of the odds ratio of patients with POC glucose monitoring vs CGM to have TBR <70mg/dL.

Figure 4. Forest plot of the odds ratio of patients with POC glucose monitoring vs CGM to have TBR <54mg/dL.

Figure 5. Forest plot of the odds ratio of patients with POC glucose monitoring vs CGM to have TAR <180mg/dL.

Figure 6. Forest plot of the odds ratio of patients with POC glucose monitoring vs CGM to have TAR <180mg/dL.
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