Glucose Self-monitoring Device Research Articles

Development of a target product profile for new glucose self-monitoring technologies for use in low- and middle-income countries.

Most glucose self-monitoring devices have been developed with high-income countries in mind. We developed a target product profile (TPP) for new glucose self-monitoring technologies for users in low- and middle-income countries (LMICs). A draft TPP including 39 characteristics was developed by an expert group including diabetes specialists, device specialists, and people with diabetes, incorporating findings from qualitative research in LMICs. Each characteristic had minimal and optimal requirements for two use cases, frequent and sporadic use. Characteristics requiring refinement were identified via online survey. Characteristics with agreement level <90% for any requirement were reviewed by the expert group and amended as appropriate. One characteristic (shelf life) had agreement <75% (both requirements for both use cases). Characteristics with agreement ≥75% and <90% for the frequent use case included infrastructure level, measurement cycle, duration of use before replacement, interchangeability, and calibration (both requirements), and activity log and price per month to end payer (minimal requirement). Intended use (both requirements), accuracy, and price per month to end payer (optimal requirement) had agreement ≥75% and <90% for the sporadic use case. This TPP will inform developers on requirements for glucose self-monitoring technologies for LMICs, and support decision-makers in evaluating existing devices.

User requirements for non-invasive and minimally invasive glucose self-monitoring devices in low-income and middle-income countries: a qualitative study in Kyrgyzstan, Mali, Peru and Tanzania

AimsDevelopment of non-invasive and minimally invasive glucose monitoring devices (NI-MI-GMDs) generally takes place in high-income countries (HICs), with HIC’s attributes guiding product characteristics. However, people living with diabetes (PLWD) in...

Knowledge and Practice of Glucose Self-Monitoring Devices among Patients with Diabetes

Background: With blood glucose self-monitoring, patients may assess how well their glucose level is controlled, and change their treatment plan as advised by their physicians. The development and increasing availability of different devices that are readily accessible play a significant role in glycemic control and prevention of complications through early recognition with proper practice.&#x0D; Methods: This observational cross-sectional study includes patients with diabetes attending Khartoum North Diabetes and Endocrinology Hospital and was carried out in April–July 2021 using convenient sampling via questionnaires obtained and filled by data collectors through interviews. Data analysis was done using SPSS software.&#x0D; Results: Out of 125 patients, 82 had prior basic knowledge about glucose self-monitoring devices. Twenty-four patients were using it regularly, and only seven were using it daily. Fifty-one patients had never used any device before. Fifty-five patients owned a device, and the rest borrowed or used devices available at healthcare centers or clinics, pharmacies, relatives’ or neighbors’ devices. Factors hindering the use of devices included financial difficulties and lack of education. Most frequent users had a stable occupation. Just below half of the patients using devices had good practice techniques with significant association with higher level of education. The rest had poor practice technique that was associated with lower level of education.&#x0D; Conclusion: Utilization of glucose self-monitoring devices is prevalent among patients with diabetes. However, many challenges require attention to facilitate ongoing self-use with proper practice in line with education and access.

Gingival Crevicular Blood Glucose as a Novel Method for Screening Diabetes Mellitus in Periodontally Compromised Patients.

Patients with periodontitis are significantly more likely to have undetected diabetes mellitus (DM). Self‑monitoring devices like glucometers provide a simple method for rapid monitoring of the glucose level in blood by utilizing a blood sample from the finger, but this method requires puncturing to obtain blood. Bleeding from the gingival sulcus, obtained during oral hygiene examination, can be utilized for screening DM patients. Therefore, this study was performed with the aim of determining the efficacy of gingival crevicular blood as a non-invasive screening method for DM patients, as well as correlating and comparing gingival crevicular blood glucose (GCBG) levels with finger capillary blood glucose (FCBG) and fasting blood glucose (FBG) among non-diabetic and diabetic group patients. In this cross-sectional comparative study, a total of 120 participants having moderate to severe gingivitis/periodontitis with an age range of 40 to 65 years were divided into two groups on the basis of FBG range taken from an antecubital vein: non-diabetic (≤126, n=60) and diabetic (≥126, n=60) groups. Blood oozing during the routine periodontal examination from the periodontal pocket was recorded using a test strip of a glucose self-monitoring device (AccuSure®Simple) as GCBG. Concomitantly FCBG was collected from the fingertip. These three parameters were statistically analyzed using the Student's t-test and the one-way ANOVA test and correlated with Pearson's correlation coefficient for both groups. The mean and standard deviation for the three parameters GCBG, FBG, and FCBG were 93.78±12.03, 89.98±13.22, and 93.08±15.56, respectively, for the non-diabetic group and 154.52±45.05, 159±47.00, and 162.23±50.60 subsequently for the diabetic group. Comparing glucose level parameters among the non-diabetic and diabetic groups suggests a significant difference with the p-value <0.001*(inter-group). ANOVA test was done for both groups suggesting no significant difference among these three methods of measuring blood glucose level, wherethe p-value found was 0.272 for the non-diabetic and 0.665 for the diabetic group (intra-group comparison). Pearson's correlation values suggested a good positive correlation for the non-diabetic group, with parameters GCBG and FBG (r=0.864), GCBG and FCBG (r=0.936), and FBG and FCBG (r=0.837). The diabetic group's Pearson's correlation suggested a highly significant positive correlation between three different methods in which GCBG and FBG (r=0.978), GCBG and FBG (r=0.977), and FBG and FCBG (r= 0.982). Blood oozing from the periodontal pocket during routine oral hygiene examination can be utilized by dental healthcare professionals to screen pre-diabetic patients which can be used as a simple and less invasive method for DM patients.

Technologies for Diabetes Self-Monitoring: A Scoping Review and Assessment Using the REASSURED Criteria.

Background:Self-management is an important pillar for diabetes control and to achieve it, glucose self-monitoring devices are needed. Currently, there exist several different devices in the market and many others are being developed. However, whether these devices are suitable to be used in resource constrained settings is yet to be evaluated.Aims:To assess existing glucose monitoring tools and also those in development against the REASSURED which have been previously used to evaluate diagnostic tools for communicable diseases.Methods:We conducted a scoping review by searching PubMed for peer-review articles published in either English, Spanish or Portuguese in the last 5 years. We selected papers including information about devices used for self-monitoring and tested on humans with diabetes; then, the REASSURED criteria were used to assess them.Results:We found a total of 7 continuous glucose monitoring device groups, 6 non-continuous, and 6 devices in development. Accuracy varied between devices and most of them were either invasive or minimally invasive. Little to no evidence is published around robustness, affordability and delivery to those in need. However, when reviewing publicly available prices, none of the devices would be affordable for people living in low- and middle-income countries.Conclusions:Available devices cannot be considered adapted for use in self-monitoring in resource constraints settings. Further studies should aim to develop less-invasive devices that do not require a large set of components. Additionally, we suggest some improvement in the REASSURED criteria such as the inclusion of patient-important outcomes to increase its appropriateness to assess non-communicable diseases devices.

Challenges for the implementation of the in-vitro diagnostics regulations in the light of â??real-lifeâ?? performance of blood glucose self-monitoring devices

Objective: Accurate and reliable blood glucose monitoring devices (BGMDs) are required for adequate self-monitoring and management for people suffering from diabetes mellitus. To ensure a high level of safety for patients and users of in vitro diagnostic devices, an updated In Vitro Diagnostic Regulation (IVDR 2017/746) has been published, including new safety and performance prerequisites. However, BGMD accuracy may be limited by certain ‘real-life’ environmental factors, which should be respected in the performance evaluation. Methods: The temperature-and humidity-dependent performance of 4 different BGMD using up to 440 capillary blood samples was determined. BGMDs with associated test strips were stored at 15°C, 25°C and 35°C resp. at a relative humidity of 40% and 80% in order to imitate potential ‘real-life’ performance settings. Glucose measurements were compared to blood glucose values determined using standardized Laboratory equipment and were analyzed based on the ISO 15197:2013 system accuracy criteria. Results: Two out of three BGMDs provided consistent results across temperature ranges based on the medical threshold of a mean glucose change less than 15 mg/dl, although blood glucose difference of up to 96 mg/dl was found at an individual patient level after pairwise temperature comparison. For one device up to 31.2% of patients’ values were outside the defined limits when comparing 15o C to 35o C. Changes in humidity levels did not significantly influence the mean values across the BGMDs, although high deviations were observed at patients’ individual glucose levels. Conclusion: Moderate temperature and humidity changes can affect the accuracy of point-ofcare devices to a profound extent at an individual patient level. These ‘real-life’ environmental factors need to be included in the performance evaluation as required in the IVDR 2017/746 in order to provide a solid testing system for novel point-of-care-devices.

A systematic review of the clinical effectiveness of monitoring patients with diabetes mellitus using individual blood glucose meters with function of transmitting measurements via gsm channel or via the internet

BACKGROUND: In recent years, there has been an active introduction of telecommunication technologies in various spheres of scientific and practical knowledge, including medicine. Diabetes mellitus (DM) is one of the most common chronic non-communicable diseases requiring constant monitoring of the patients condition. For telemedicine monitoring of patients with DM, glucose self-monitoring devices with the option of transmitting patients measurements via GSM channel or via the Internet have been developed.&#x0D; AIM: To evaluate the clinical effectiveness of telemedicine observation of patients with DM using individual glucose self-monitoring devices with option of transmitting patients measurements via a GSM channel or via the Internet.&#x0D; MATERIALS AND METHODS: Publications about clinical trials were searched in PubMed. The search, selection and evaluation of the methodological quality of clinical trials were carried out by two independent researchers. Clinical trials were included in the review if the clinical efficacy of remote monitoring of patients with DM using individual glucose self-monitoring devices with the option of transmitting the results of measurements taken by the patient via a GSM channel or via the Internet was evaluated in comparison with traditional observation methods.&#x0D; RESULTS: As a result of the systematic search, 10 original randomized controlled trials (RCTs) with different methodological quality were selected. It was found that the use of remote technologies for 12 months does not affect the level of glycated hemoglobin, however, it allows to increase the frequency of achieving individual therapeutic goals in patients with type 2 DM. In addition, it was found that the use of remote technologies allows to reduce the frequency of outpatient visits of patients with type 2 DM, but does not reduce the length of hospitalization and the frequency of an emergency calls of these patients.&#x0D; CONCLUSION: Thus, evidence was obtained of the potential therapeutic benefits of remote observation of patients with diabetes based on data from foreign clinical studies. Based on the results obtained, a Russian clinical trial of this medical technology can be recommended.

Changes in Self-Care Behavior (Summary of Diabetes Self-Care Activities Measure) Using Real-Time Blood Glucose Monitoring with the Free Style Libre

No studies have reported changes in self-care behavior, and it remains unclear whether Free Style Libre (Libre) differs from conventional blood glucose self-monitoring devices in this regard. Therefore, we instructed diabetes patients using conventional self-monitoring blood glucose (SMBG) devices to use the Libre and prospectively examined the effect of this new device on self-care behavior and patient treatment satisfaction. The subjects comprised 41 outpatients with diabetes who were using conventional SMBG devices. The subjects were randomly assigned to group A, which comprised patients using Libre for ≥2 weeks (n = 21), or group B, which comprised patients who continued using conventional SMBG devices (n = 20). All patients received 30 minutes of diet and exercise therapy instruction from a registered dietitian and nurse (or clinical laboratory technologists). The Summary of Diabetes Self-Care Activities measure (SDSCA) was administered at baseline, 1, 3, and 6 months. Changes in the SDSCA, glycated hemoglobin (HbA1c), glycated albumin (GA), and body weight from baseline to 1 month were analyzed (UMIN000029016). At baseline, the two groups did not differ significantly in terms of the HbA1c, GA, body weight, or 17 SDSCA items. At 1 month, the numbers of days involving eating five or more servings of fruits and vegetables were 5.0 (3.3, 6.8) in group A and 3.0 (1.0, 6.0) in group B, the numbers of days involving exercise for at least 30 minutes were 5.0 (2.0, 6.0) in group A and 2.0 (0, 3.0) in group B, and the number of days involving specific exercise were 3.0 (2.0, 6.0) in group A and 1.5 (0, 2.3) in group B; both of these values were significantly higher in group A than in group B (p = 0.033, 0.037 and 0.041, respectively). These results suggest that the use of the Libre may improve the self-care behaviors of diabetes patients regarding diet and exercise, compared with the use of conventional SMBG devices. Disclosure A. Kudara: None. T. Tosaki: Other Relationship; Self; Eli Lilly and Company, Takeda Development Center Asia, Pte. Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation. S. Sato: None. A. Inagaki: None. M. Kondo: None. S. Tsunekawa: None. Y. Kato: Speaker's Bureau; Self; Merck Sharp &amp; Dohme Corp., Sanofi, Takeda Pharmaceutical Company, Eli Lilly Japan. H. Kamiya: Other Relationship; Self; MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., AstraZeneca, Astellas Pharma KK, Eli Lilly and Company, Novartis Pharma K.K., Dainippon Sumitomo Pharma Co., Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd. J. Nakamura: Other Relationship; Self; Astellas Pharma US, Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., MSD K.K., Kyowa Hakko Kirin Co., Ltd., Kowa Pharmaceuticals America, Inc., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly and Company, Novartis Pharma K.K., Pfizer Inc..

Prescribing of Electronic Activity Monitors in Cardiometabolic Diseases: Qualitative Interview-Based Study.

BackgroundThe prevalence of noncommunicable diseases, including those such as type 2 diabetes, obesity, dyslipidemia, and hypertension, so-called cardiometabolic diseases, is high and is increasing worldwide. Strong evidence supports the role of physical activity in management of these diseases. There is general consensus that mHealth technology, including electronic activity monitors, can potentially increase physical activity in patients, but their use in clinical settings remains limited. Practitioners’ requirements when prescribing electronic activity monitors have been poorly described.ObjectiveThe aims of this qualitative study were (1) to explore how specialist physicians prescribe electronic activity monitors to patients presenting with cardiometabolic conditions, and (2) to better understand their motivation for and barriers to prescribing such monitors.MethodsWe conducted qualitative semistructured interviews in March to May 2016 with 11 senior physicians from a public university hospital in France with expertise in management of cardiometabolic diseases (type 1 and type 2 diabetes, obesity, hypertension, and dyslipidemia). Interviews lasted 45 to 60 minutes and were audiotaped, transcribed verbatim, and analyzed using directed content analysis. We report our findings following the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist.ResultsMost physicians we interviewed had never prescribed electronic activity monitors, whereas they frequently prescribed blood glucose or blood pressure self-monitoring devices. Reasons for nonprescription included lack of interest in the data collected, lack of evidence for data accuracy, concern about work overload possibly resulting from automatic data transfer, and risk of patients becoming addicted to data. Physicians expected future marketing of easy-to-use monitors that will accurately measure physical activity duration and intensity and provide understandable motivating feedback.ConclusionsFeatures of electronic activity monitors, although popular among the general public, do not meet the needs of physicians. In-depth understanding of physicians’ expectations is a first step toward designing technologies that can be widely used in clinical settings and facilitate physical activity prescription. Physicians should have a role, along with key health care stakeholders—patients, researchers, information technology firms, the public, and private payers—in developing the most effective methods for integrating activity monitors into patient care.

Hemoglobin A1C as an indicator of the accuracy of blood glucose measurement: comparative study of three technologies used for blood glucose measurements

In previous studies, the accuracy of glucose measurements were found with significant variations in different self-monitoring devices. This study suggests Hemoglobin a1c (Hba1c) to be used as as an indicator for the accuracy of blood-glucose monitoring devices. In this study, the association between the readings of glycohematoglobin HbA1C and the hyperglycemic readings of thirty hyperglycemic patients is used as an indicator of the accuracy of three types of glucometer devices. The association between hyperglycemic readings and the percentage of HbA1C for the same patients was investigated. The results showed significant association between levels of blood glucose and the percentage of HbA1C in three devices with statistically significant ( p &lt; 0.05). Such relationship is suggested to be used as a relative accuracy of various types of blood glucose self-monitoring devices.

Evaluation of gingival blood as a minimally invasive screening tool for diabetes mellitus among 40-59-year-old adults in dental clinics: A cross-sectional study.

To evaluate a quick, safe, and minimally invasive method to screen for diabetes using gingival blood with the help of self-monitoring glucometer during periodontal examination. A hospital-based, cross-sectional comparative study was conducted among 40-59-year-old diabetic and nondiabetic population who had come for their master health examination to a private tertiary care hospital (Global Hospital and Health City) in Chennai. Among them, those who fulfilled the inclusion criteria were selected for the study. Thirty diabetic and thirty nondiabetic patients with moderate to severe gingivitis were enrolled and subjected to routine clinical periodontal examination. Blood samples of two sites were analyzed using a glucose self-monitoring device (Accu-Check). Patients were tested for venous fasting blood sugar (VFBS), venous postprandial blood sugar (VPPS), gingival fasting blood sugar (GFBS) level, gingival postprandial blood sugar (GPPS) level, peripheral fingerstick fasting blood sugar (PFBS) level, and peripheral fingerstick postprandial sugar (PPPS) level. Data obtained were statistically analyzed using Student's t-test, ANOVA, and Pearson's correlation test. A significant positive correlation was found between GFBS and VFBS, GFBS and PFBS, GPPS and VPPS, and GPPS and PPPS (P < 0.01) in both diabetic and nondiabetic patients correlation. Using venous blood glucose level as a gold standard, the sensitivity and specificity of GFBS was 93% and 100%, respectively, whereas in GPPS, the sensitivity and specificity was 80% and 96%, respectively. Gingival blood glucometry can be used as a minimally invasive screening tool for diabetes mellitus in dental clinics.

Gingival crevicular blood: A noninvasive pathway to determine blood glucose level in periodontal patients

Aim: The aim of this study is to determine the efficacy and reliability of estimation of blood glucose level of patients with diabetes suffering from periodontal disease using gingival crevicular blood through periodontal pockets. Materials and Methods: A total of 70 patients with a known history of diabetes mellitus suffering from chronic periodontal diseases having visible signs of gingival inflammation were selected for the study based on other inclusion criteria. The excess gingival crevicular blood produced during routine periodontal examinations were carefully collected onto the glucometer test strips, and blood glucose levels were estimated with the help of glucose self-monitoring device (Glucometer). The finger-prick blood samples were also collected and glucose levels were also estimated using Glucometer. Patient's venous blood samples were collected at the same time, and blood glucose estimations were done using conventional laboratory measurements. Results: The results of this study revealed a strong correlation between (a) the gingival crevicular blood glucose (GCBG) and finger-prick blood glucose (Pearson's correlation r = 0.982; P < 0.001); and also (b) between GCBG and corrected venous blood glucose (Pearson's correlation r = 0.891; P < 0.001). Conclusion: Oozing blood from the gingival crevice during the routine periodontal examination can be used as a quick, noninvasive, chair-side diagnostic mode to estimate, and/or monitor blood glucose levels in periodontal patient suffering from diabetes mellitus with the help of Glucometer.

Gingival crevicular blood for screening of blood glucose level in patients with & without diabetes: a chair-side test.

Diabetes is a pandemic disease with increasing prevalence and serious complications. Periodontitis being one of its presentation and is its sixth recognized complication. This study compares blood glucose levels in gingival crevicular blood of patients with and without diabetes elicited during routine periodontal probing and venous blood sample. Seventy patients with moderate gingivitis and periodontitis positive for bleeding on probing were chosen. All the subjects were divided in two groups, group I consisted of 35 diabetic and group II of 35 non-diabetic subjects. Blood from the gingiva of the most inflamed site was collected with the test strip of a glucose self-monitoring device, and the blood glucose levels were measured. At the same time, intravenous blood was collected for measurement in a laboratory glucose analyzer. Gingival index and probing pocket depth were evaluated for each subject at same time. The mean GCB levels and VB derived from all samples were 156.07±49.23mgdl(-1) and 156±49.89mgdl(-1) , respectively, for diabetic group and 90.80±11.07 and 93.41±9.30 for non-diabetic group. In both the groups, the difference between GCB and VB glucose levels was non-significant (P>0.005). Highly significant correlation between GCB and VB (r=0.972 for diabetic and r=0.721 for non-diabetic) in both the groups was found. The data from this study show that GCB collected during diagnostic periodontal examination can be an excellent source for estimation of blood sugar or glucometric analysis. This technique is also suitable for routine screening of diabetic and early diagnosis of unknown diabetic cases.

Correlation of blood glucose level in gingival crevicular blood and finger capillary blood using glucometer

Aim: The aim of the study was to assess the reliability of gingival crevicular blood (GCB) glucose level compared with finger capillary blood (FCB) glucose level using a glucose self-monitoring device (Contour ® TS). Materials and Methods: One hundred randomly selected patients with gingivitis (45 subjects) and periodontitis (55 subjects) were included in the study. The mean age of the study group subjects was 35.39 ± 11.97 years (range 17-70 years). The blood glucose values obtained from GCB elicited during routine periodontal probing and those of peripheral finger stick blood glucose were recorded using a glucose self-monitoring device (glucometer) during fasting and postprandial phases. Statistical analysis was done using Student's t test and Karl Pearson's product moment correlation. The regression analysis was then performed to compare the GCB and FCB blood glucose readings using the approach of Bland and Altman. Results: There was no statistically significant difference (t = 1.443, P = 0.152) between the fasting GCB and FCB glucose values, but it was significant during postprandial measurement (t = 6.893, P

Detection of blood glucose level through gingival crevicular blood - A pilot study

Background: Diabetes mellitus (DM) is one of the most important risk factors for destructive periodontitis. It is possible that gingival crevicular blood from routine periodontal probing may be a source of blood for glucose measurements. Aim: To compare gingival crevicular blood and finger stick blood glucose measurements using a self-monitoring device. Materials and Method: 30 patients with periodontitis and positive bleeding on probing were chosen. Blood samples of two sites were analyzed using a glucose self-monitoring device. Glucose levels in gingival crevicular blood (GCBG) and capillary finger prickblood (CFBG) samples were analyzed using the same device. The following clinical periodontal parameters were recorded: probing depth, gingival bleeding index, clinical attachment loss and periodontal disease index. The Statistical Analysis was carried out. Results:Sufficiently large GCB volumes provided glucometer readings in all 30 cases (range between60 and 160 mg/dl). The CFB readings ranged between 60 and 166 mg/dl. Karl Pearson’s product–moment correlation coefficient was calculated, which showed a positive correlation between the two measurements (r = 0.592) and p- value (0.001). Conclusion: Gingival crevicular blood can be used for testing blood glucose during periodontal examination in patients with periodontal disease. Keywords: Chronic periodontitis, Diabetes mellitus, Gingival crevicular blood, Capillary finger prick blood

Diagnostic Efficacy of Gingival Crevicular Blood for Assessment of Blood Glucose Levels in Dental Office: A cross Sectional Study

Objectives: The gingival crevicular blood (GCB) obtained during routine periodontal probing may be a source for blood glucose measurements. The aim of this study was to compare gingival crevicular blood and fingerstick blood glucose measurements using a glucometer against the conventional laboratory methods. Materials and Methods: The study group comprised of three groups. In the first group 30 patients with periodontitis and positive bleeding on probing were chosen. Blood samples of two sites intraorally were analyzed using a glucose self-monitoring device. The second and third group comprised of 50 diabetic and 50 non-diabetic patients. After testing fasting plasma glucose (FPG), fasting glucose levels in gingival crevicular blood (GCBG), and fasting capillary fingerstick blood (CFBG) samples were analyzed using same device. Results: Significant correlation (r= 0.93, p<0.001) was found between gingival crevicular blood glucose levels and capillary finger stick blood glucose levels. Considerable correlation (r=0.75, p<0.001) was found between levels of fasting gingival crevicular blood glucose and fasting blood glucose both in diabetic patients and the normal population. Conclusion: It is evident that the blood obtained during routine periodontal probing can be used for estimation of blood glucose levels. GCB can be used as a marker for blood glucose estimation using glucometer. The technique described is safe, easy to perform and helps to increase the frequency of diabetes screening in dental office.

Developing a chair side, safe and non-invasive procedure for assessment of blood glucose level using gingival crevicular bleeding in dental clinics.

Aim:To study the accessibility of chair side blood glucose non-invasive screening method for diabetes mellitus during routine periodontal examination.Materials and Methods:Fifteen non-diabetics and 15 newly onset type 2 diabetics patients with moderate to severe periodontitis were selected after meeting inclusion and exclusion criteria. Periodontal pocket probing was performed using a Williams Graduated periodontal probe. Blood oozing from gingival sulcus of anterior teeth following periodontal pocket probing was collected with stick of a glucose self-monitoring device. As control, finger stick capillary blood was taken.Results:A statistically significant correlation was observed between the blood glucose level of gingival crevicular blood (GCB) and peripheral fasting blood (PFB) of diabetic subjects. The mean GCB glucose level of the subjects in diabetic group was 172.27 ± 5.02 mg/dl while mean PFB glucose was 167.80 ± 8.87 mg/dl. The correlation coefficient of diabetic and non-diabetic subjects were r = +0.715 and r = +0.619, respectively.Conclusion:The results suggested that blood oozing during routine periodontal examination may be used for diabetic mellitus screening in a dental office setting without the need for any extra procedure.

Assessment of Blood Glucose Using Gingival Crevicular Blood in Diabetic and Non-Diabetic Patients: A Chair Side Method

Diabetes mellitus is undiagnosed in approximately half of the patients actually suffering from the disease. The prevalence of diabetes mellitus is nearly twice in patients with periodontitis as compared to periodontally healthy subjects.In addition, the prevalence of Diabetes mellitus is more than twice as high as in patients with periodontitis when compared to periodontally healthy subjects. The purpose of the present study was to evaluate whether blood oozing from gingival crevice during routine periodontal examination can be used for determining glucose levels. In the present study 50 patients(25 diabetic and 25 non-diabetic) with chronic periodontitis were selected and were divided into two groups i.e. Group I and Group II, respectively. Blood glucose measurements were made using gingival crevicular blood, finger stick blood using glucose self-monitoring device (Finetest(TM); Infopia Co.Ltd;Korea) and at the same time intra venous blood was collected for measurement in a laboratory glucose analyzer. Each laboratory measurement was corrected from a serum glucose value to a whole blood glucose value by a function of the patient's haematocrit. The patient's blood glucose values ranged from 83.6 to 483mg/dl in diabetic patients(Group I) and 70-218 mg/dl in non-diabetic individuals (Group II) to 83.6 to 483mg/dl. The comparison between gingival crevicular blood, finger-prick blood and corrected intra venous blood showed a very strong correlation with an r value of 0.99(P level< 0.001) CONCLUSION: The data from this study has shown that gingival crevicular blood collected during diagnostic periodontal examination can be an excellent source of blood for glucometric analysis.

Gingival crevicular blood: As a non-invasive screening tool for diabetes mellitus in dental clinics.

Background:A high number of patients with periodontitis may have undiagnosed diabetes. Self-monitoring devices provide a simple method for rapid monitoring of the glucose level in the blood by utilizing a blood sample from the finger, but this method requires a needle puncture to obtain blood. It is possible that gingival crevicular blood (GCB) from routine periodontal probing may be a source of blood for glucose measurements.Aim:To establish whether GCB can be used as a non-invasive diagnostic aid in screening for diabetes mellitus during routine periodontal examination.Materials and Methods:The study involved 50 diabetics and 50 non-diabetics, with an age range of 26-66 years. Both diabetic and non-diabetic patients had moderate to severe gingivitis with at least one tooth in the maxillary anterior region showing bleeding upon probing. The Gingival Index and Oral Hygiene Index-Simplified were recorded. Blood oozing from the gingival sulcus/pocket following periodontal pocket probing was collected using a capillary tube and transferred to the test stick of a glucose self-monitoring device (Accu-Chek, Roche Diagnostic, Germany) in patients with comparable gingival and oral hygiene status. This value was compared with the peripheral fingerstick blood glucose (PFBG) value, which was obtained by pricking the finger tip at the same visit. Statistical analysis was performed using Pearson's correlation coefficient.Result:There was no statistically significant difference between the gingival crevicular blood glucose (GCBG) values and the PFBG values in both the diabetic (P = 0.129, NS) and the non-diabetic (P = 0.503, NS) groups. Karl Pearson's product–moment correlation coefficient was calculated, which showed a positive correlation between the two measurements in the diabetic (r = 0.943) as well as the non-diabetic (r = 0.926) groups.Conclusion:The results suggest that GCB can be used as a non-invasive diagnostic aid in screening for diabetes mellitus during routine periodontal examination.

Correlation between Levels of Sulcular and Capillary Blood Glucose

The aim of this study was to evaluate the correlation between capillary blood glucose levels (CBGLs) and sulcular blood glucose levels (SBGLs) using blood obtained from gingival tissue during routine periodontal examinations to determine if sulcular blood samples can be used as a non-invasive means to diagnosis blood glucose levels. Thirty non-diabetics and 30 diabetic patients with moderate to severe periodontitis were included in the study and subjected to routine clinical periodontal examinations. Blood was collected using a 1.6-1.8 mm diameter micro bite collection tube to transport the sample from the gingival sulci of anterior teeth following periodontal pocket probing to a test strip of a glucose self-monitoring device. As a control, capillary blood was taken with a finger-stick. Statistical analysis was performed using the Pearson's correlation coefficient and a t-test. The blood glucose levels in patients ranged from 58 mg/dl to 477 mg/dl, and the values of blood samples taken from gingival sulcus or finger tip of the same patient showed a very high intra-patient correlation (r =0.99, p< 0.0001). The results of this study suggest sulcular blood from a routine periodontal examination may be used for diabetes mellitus screening. Considering 50% of diabetics remain undiagnosed, testing sulcular blood may provide a suitable method for identifying potential diabetic patients during routine dental visits since there is a correlation with capillary blood. Appropriate referrals to a physician can then be made when warranted.