Diabetes Technology Society

Blood Glucose Monitoring System Surveillance Program

Congressional diabetes Caucus & HHS Correspondence About DTS BGMS Surveillance Program

August 27, 2018 Response to Department of Health and Human Services from Congressional Diabetes Caucus

January 24, 2018 Response to Congressional Diabetes Caucus from Department of Health and Human Services

December 6, 2017 Letter to Department of Health and Human Services from Chairs of Congressional Diabetes Caucus

Blood Glucose Monitor Surveillance Article

Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. David C. Klonoff, Joan Lee Parkes, Boris P. Kovatchev, David Kerr, Wendy C. Bevier, Ronald L. Brazg, Mark Christiansen, Timothy S. Bailey, James H. Nichols and Michael A. Kohn. Diabetes Care 2018 Aug; 41(8): 1681-1688.

Summary of Results

The Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program was established because of evidence that cleared BGMSs do not always achieve levels of accuracy matching either: 1) their performance that resulted in becoming cleared by FDA; or 2) international standards of accuracy. Poor performance of these devices can lead to adverse clinical and economic consequences. This surveillance program assessed the accuracy of 18 blood glucose monitoring systems (BGMSs) marketed in the USA across a wide range of blood glucose levels in the hands of trained professionals. These 18 BGMSs represented approximately 90% of the commercially available systems that were used from 2013 to 2015 by diabetes patients and obtained from consumer outlets.

Subjects 18 years and older with type 1 diabetes, type 2 diabetes, pre-diabetes, or no diabetes, participated at 3 clinical sites. Each clinical site conducted 3 consecutive sub-studies. In each of the sub-studies, subjects' finger-stick blood was assessed on 6 different marketed BGMSs, and a tube of capillary blood was collected, and the plasma prepared from it was frozen and sent to a separate laboratory site to assay on the glucose comparative instrument (YSI). At each clinical site, 3 separate studies were conducted with a different set of 6 BGMSs in each. This assured that all 18 BGMS were tested at all 3 clinical sites. The results of first study performed at each of three sites were combined into Study 1, the results of the second study at each site were combined into Study 2, and the results of the third study at each site were combined into Study 3.

Glycolized blood samples were tested to ascertain the accuracy of BGMSs in the very low blood glucose range. At each of the three sites during each of the three studies, an additional tube of capillary blood was collected from approximately 20 subjects. This blood was glycolyzed to achieve very low glucose values that could not be safely obtained naturally. The glycolyzed blood was tested on the oxygen insensitive BGMSs whose labels specified glucose dehydrogenase chemistry, which is oxygen insensitive. Plasma from each tube was then prepared, frozen, and sent to the research laboratory site for assay on a comparative reference glucose instrument (YSI 2300 STAT PLUS Glucose & L-Lactate Analyzer). At the research laboratory site, the frozen tubes of plasma were thawed, thoroughly mixed, and assayed on YSI instruments whose accuracy was validated and traceable to a higher order using NIST 965b Standards. The results of these measurements of glycolized specimens were analyzed separately from the results of natural specimens that were used in the pass-fail analysis process.

This study was triple blinded. None of the people involved in conducting this study (i.e. neither investigators, laboratory staff, statistician, nor sponsor) had all the information to break the BGMS code until all results were calculated and posted.

Analyses were performed to determine whether the 18 BGMSs, assayed with natural samples (that is blood samples taken directly from a subject's finger), met pre-determined analytical accuracy criteria agreed upon by the DTS-BGMS Surveillance Committee. The protocol specified that to be compliant a blood glucose value must be within 15% of a reference plasma value for a blood glucose >100 mg/dl and within 15 mg/dl of a reference plasma value for a blood glucose <100 mg/dl. These protocol criteria were similar to: 1) (for all blood glucose levels) the latest ISO standard (ISO15197-2013, "In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus"), which was in effect when the protocol was developed; and 2) (for a blood glucose >100 mg/dl) the latest FDA guidance (FDA 2016, "Self-Monitoring of Blood Glucose Test Systems for Over-the-Counter Use"), which was released after the protocol was developed. The number of compliant readings needed to pass depended on the number of trials. For a study of 100 trials, at least 91 readings were required to be within 15% or 15 mg/dL of the reference value. A BGMS that passed all 3 studies received the DTS Seal of Approval.

The frequency of outliers for each BGMS was assessed with a modified Bland-Altman analysis along with calculation of bias, Coefficient of Variation, 95% limits of agreement, and the absolute value of the greatest 95% limit of agreement.

Clinical accuracy was determined by Surveillance Error Grid analysis. The absolute values of clinical risk levels from 0-4 were separated into five bins. Each data point was assigned to a bin corresponding to the absolute value of its clinical risk.

These three studies were performed on 1035 participating subjects total at three clinical sites: Rainier Clinical Research Center, Inc. (n=353); Diablo Clinical Research (n=335); and AMCR Institute, Inc. (n=347). Plasma reference laboratory testing was performed at The William Sansum Diabetes Center. Six BGMSs were assayed in each sub-study, assuring that each clinical site assayed all 18 BGMSs. The results for each BGMS (i.e., approximately one third from each clinical site) were combined in the analysis of overall compliance to produce the overall combined results of 3 repeated studies for each BGMS. A Seal of Approval was awarded to any BGMS that passed all 3 of the 3 studies. The determination of whether to award a Seal of Approval was not based on: overall analytical performance of the 3 studies; variability; clinical accuracy; or accuracy for testing glycolized hypoglycemic plasma specimens.

The topline results are summarized in the tables below. We tested 18 BGMSs in 3 studies each. The results were that only 6 of the 18 BGMSs passed all 3 times and received the Seal of Approval.

Demographics
Subject Demographic Characteristic	N = 1035
Gender
Female	560
Male	471
Not specified	4
Type of Diabetes
Type 1	370
Type 2	470
Pre-diabetes	4
Does not have diabetes	187
Not specified	4
Age (Years)
Range	18-87
Mean	51.5
Race^*
White/Caucasian	851
Black/African American	91
Hispanic	156
Native American/Aboriginal	9
Asian	47
Other and not specified	37
^*Some subjects identified themselves in more than one category

Main Results
				Study 1			Study 2			Study 3			Overall
	Brand	Blood Glucose Monitor	Test Strip	N	Percentage Compliant^†	Pass/ Fail	N	Percentage Compliant	Pass/ Fail	N	Percentage Compliant	Pass/ Fail	Passes out of 3 Studies	Seal of Approval?	Valid Trials	Compliant N	Compliant %
98.4%	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	97	97%	PASS	101	100%	PASS	113	98%	PASS	3	YES	311	306	98%
95.3%	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	108	98%	PASS	106	96%	PASS	106	92%	PASS	3	YES	320	305	95%
75.5%	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	102	88%	FAIL	114	71%	FAIL	103	68%	FAIL	0	NO	319	241	76%
88.8%	Bayer	Contour Classic	Contour	108	95%	PASS	106	85%	FAIL	106	86%	FAIL	1	NO	320	284	89%
99.7%	Bayer	Contour Next	Contour Next	98	99%	PASS	101	100%	PASS	113	100%	PASS	3	YES	312	311	100%
96.5%	Agamatrix	CVS Advanced	CVS Advanced	101	96%	PASS	114	96%	PASS	103	98%	PASS	3	YES	318	307	97%
88.4%	Omnis Health	Embrace	Embrace No Code	102	87%	FAIL	114	93%	PASS	103	84%	FAIL	1	NO	319	282	88%
95.5%	Abbott	FreeStyle Lite	FreeStyle Lite	98	92%	PASS	101	96%	PASS	113	98%	PASS	3	YES	312	298	96%
70.6%	Philosys, Inc.	Gmate Smart	Gmate	108	61%	FAIL	106	79%	FAIL	106	72%	FAIL	0	NO	320	226	71%
90.0%	LifeScan	OneTouch Ultra2	OneTouch Ultra	97	92%	PASS	101	84%	FAIL	113	94%	PASS	2	NO	311	280	90%
92.2%	LifeScan	OneTouch Verio	OneTouch Verio	108	87%	FAIL	106	98%	PASS	105	91%	PASS	2	NO	319	294	92%
90.3%	Prodigy	Prodigy Auto Code	Prodigy No Coding	98	86%	FAIL	101	92%	PASS	113	93%	PASS	2	NO	312	282	90%
76.3%	BioSense Medical	SolusV2	SOLUS	108	56%	FAIL	106	84%	FAIL	106	89%	FAIL	0	NO	320	244	76%
87.7%	HDI/Nipro	True Result	TrueResult	101	94%	PASS	114	83%	FAIL	103	86%	FAIL	1	NO	318	279	88%
81.5%	HDI/Nipro	True Track	TrueTrack	102	83%	FAIL	103	80%	FAIL	—	—	FAIL*	0	NO	205	167	81%
92.3%	Arkray	Walmart ReliOn Prime	ReliOn Prime	98	85%	FAIL	101	95%	PASS	113	96%	PASS	2	NO	312	288	92%
96.8%	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	100	96%	PASS	114	96%	PASS	103	99%	PASS	3	YES	317	307	97%
89.3%	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	107	96%	PASS	106	97%	PASS	106	75%	FAIL	2	NO	319	285	89%
	^*No Study 3 data for HDI/Nipro TrueTrack because of test strip recall. ^†Within 15% of reference value if ≥ 100 mg/dL or 15 mg/dL of reference value if ≤ 100 mg/dL. In Studies 1, 2, and 3, each of the 18 blood glucose monitoring systems (BGMSs) was tested at 3 different sites. Over the 3 studies each BGMS was tested once by each site. The number of compliant readings needed to pass depends on the number of trials. For 100 trials, at least 91 readings must be within 15% or 15 mg/dL of the reference value. Full methodology of the study will be published.

Overall Results
					Trials Within Protocol Limits
Sort Order	Brand	Blood Glucose Monitor	Test Strip	Valid Trials	N	%
98.4%	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	311	306	98%
95.3%	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	320	305	95%
75.5%	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	319	241	76%
88.8%	Bayer	Contour Classic	Contour	320	284	89%
99.7%	Bayer	Contour Next	Contour Next	312	311	100%
96.5%	Agamatrix	CVS Advanced	CVS Advanced	318	307	97%
88.4%	Omnis Health	Embrace	Embrace No Code	319	282	88%
95.5%	Abbott	FreeStyle Lite	FreeStyle Lite	312	298	96%
70.6%	Philosys, Inc.	Gmate Smart	Gmate	320	226	71%
90.0%	LifeScan	OneTouch Ultra2	OneTouch Ultra	311	280	90%
92.2%	LifeScan	OneTouch Verio	OneTouch Verio	319	294	92%
90.3%	Prodigy	Prodigy Auto Code	Prodigy No Coding	312	282	90%
76.3%	BioSense Medical	SolusV2	SOLUS	320	244	76%
87.7%	HDI/Nipro	True Result	TrueResult	318	279	88%
81.5%	HDI/Nipro	True Track	TrueTrack	205	167	81%
92.3%	Arkray	Walmart ReliOn Prime	ReliOn Prime	312	288	92%
96.8%	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	317	307	97%
89.3%	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	319	285	89%
	Total Data Pairs			5584

Summary of Modified Bland-Altman Comparison
							95% Limits of agreement^†
Sort Order	Brand	Blood Glucose Monitor	Test Strip	Valid Trials	Bias	Coefficient of Variation^*	Lower Limit		Upper Limit	Larger Absolute Limit Boundary^‡	B-A Plot
98.4%	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	311	-3.4%	6.3%	-15%	-	9%	15%
95.3%	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	320	-5.3%	6.5%	-17%	-	8%	17%
75.5%	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	319	-9.1%	10.5%	-26%	-	12%	26%
88.8%	Bayer	Contour Classic	Contour	320	-6.5%	9.7%	-23%	-	13%	23%
99.7%	Bayer	Contour Next	Contour Next	312	-1.2%	5.3%	-11%	-	10%	11%
96.5%	Agamatrix	CVS Advanced	CVS Advanced	318	-0.3%	7.0%	-13%	-	14%	14%
88.4%	Omnis Health	Embrace	Embrace No Code	319	0.9%	10.0%	-17%	-	23%	23%
95.5%	Abbott	FreeStyle Lite	FreeStyle Lite	312	-6.0%	7.4%	-19%	-	9%	19%
70.6%	Philosys, Inc.	Gmate Smart	Gmate	320	5.7%	15.5%	-22%	-	43%	43%
90.0%	LifeScan	OneTouch Ultra2	OneTouch Ultra	311	-3.0%	9.3%	-19%	-	17%	19%
92.2%	LifeScan	OneTouch Verio	OneTouch Verio	319	5.9%	6.8%	-7%	-	21%	21%
90.3%	Prodigy	Prodigy Auto Code	Prodigy No Coding	312	1.2%	10.3%	-17%	-	24%	24%
76.3%	BioSense Medical	SolusV2	SOLUS	320	-10.1%	8.1%	-23%	-	5%	23%
87.7%	HDI/Nipro	True Result	TrueResult	318	-8.9%	8.2%	-22%	-	7%	22%
81.5%	HDI/Nipro	True Track	TrueTrack	205	-6.9%	10.6%	-24%	-	15%	24%
92.3%	Arkray	Walmart ReliOn Prime	ReliOn Prime	312	0.4%	9.5%	-17%	-	21%	21%
96.8%	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	317	2.4%	6.8%	-10%	-	17%	17%
89.3%	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	319	3.0%	10.2%	-16%	-	26%	26%
	^*Standard deviation of the difference in the log-transformed measurements, which is essentially the same as the standard deviation of the % difference = (BGMS Reading - Reference Value)/(Reference Value) ^†95% Limits of Agreement define the range around the reference value containing 95% of the BGMS readings. ^‡Limit boundary with the larger absolute value Modified Bland-Altman analysis compares the difference (BGMS Reading - Reference Value) to the reference value rather than comparing the difference to the average of the BGMS reading and the reference value. The bias is the average difference as a percent of the reference value. A bias of -5.0% means the BGMS meter reading is, on average, 5% lower than the reference value. The 95% Limits of Agreement define the range around the reference value containing 95% of the BGMS readings.

number and percent of values within specified error limits
					Distance from the Reference Value^*
	Brand	Blood Glucose Monitor	Test Strip	Valid Trials	Within +/- 5%		Within +/- 10%		Within +/- 15%^†		Within +/- 20%		>20%
					N	%	N	%	N	%	N	%	N	%
	Bayer	Contour Next	Contour Next	312	212	68%	302	97%	311	100%	311	100%	1	0.3%
	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	311	161	52%	272	87%	306	98%	311	100%	0	0.0%
	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	317	167	53%	276	87%	307	97%	314	99%	3	0.9%
	Agamatrix	CVS Advanced	CVS Advanced	318	172	54%	272	86%	307	97%	317	100%	1	0.3%
	Abbott	FreeStyle Lite	FreeStyle Lite	312	95	30%	238	76%	298	96%	306	98%	6	1.9%
	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	320	133	42%	251	78%	305	95%	317	99%	3	0.9%
	Arkray	Walmart ReliOn Prime	ReliOn Prime	312	121	39%	224	72%	288	92%	305	98%	7	2.2%
	LifeScan	OneTouch Verio	OneTouch Verio	319	139	44%	239	75%	294	92%	315	99%	4	1.3%
	Prodigy	Prodigy Auto Code	Prodigy No Coding	312	135	43%	229	73%	282	90%	304	97%	8	2.6%
	LifeScan	OneTouch Ultra2	OneTouch Ultra	311	127	41%	230	74%	280	90%	302	97%	9	2.9%
	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	319	140	44%	241	76%	285	89%	302	95%	17	5.3%
	Bayer	Contour Classic	Contour	320	109	34%	215	67%	284	89%	313	98%	7	2.2%
	Omnis Health	Embrace	Embrace No Code	319	116	36%	230	72%	282	88%	308	97%	11	3.4%
	HDI/Nipro	True Result	TrueResult	318	81	25%	188	59%	279	88%	311	98%	7	2.2%
	HDI/Nipro	True Track	TrueTrack	205	57	28%	112	55%	167	81%	186	91%	19	9.3%
	BioSense Medical	SolusV2	SOLUS	320	59	18%	148	46%	244	76%	297	93%	23	7.2%
	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	319	66	21%	148	46%	241	76%	288	90%	31	9.7%
	Philosys, Inc.	Gmate Smart	Gmate	320	82	26%	159	50%	226	71%	267	83%	53	16.6%
^*When reference value is <100 mg/dL, then distance is absolute mg/dL rather than %. ^†The percentage of data points within +/- 15% distance from the Reference Value is the same as the percentage of data points for Trials Within Protocol Limits in the Overall Results Table.

Proportion of blood glucose monitor readings within a given distance from the reference value.

Summary of Surveillance Error Grid Comparison
					Risk
Sort Order	Brand	Blood Glucose Monitor	Test Strip	Total Data Pairs	Percentage with No Risk	None 0–0.5	Slight, Lower >0.5–1.0	Slight, Higher >1.0–1.5	Moderate, Lower >1.5–2.0	Moderate, Higher >2.0–2.5	Severe, Lower >2.5-3.0	Severe, Higher >3.0-3.5	Extreme, >3.5-4.0
98.4%	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	311	99.7%	310	1
95.3%	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	320	97.8%	313	7
75.5%	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	319	87.5%	279	38	2
88.8%	Bayer	Contour Classic	Contour	320	93.1%	298	20		2
99.7%	Bayer	Contour Next	Contour Next	312	99.4%	310	2
96.5%	Agamatrix	CVS Advanced	CVS Advanced	318	98.7%	314	4
88.4%	Omnis Health	Embrace	Embrace No Code	319	96.6%	308	8	3
95.5%	Abbott	FreeStyle Lite	FreeStyle Lite	312	97.1%	303	8	1
70.6%	Philosys, Inc.	Gmate Smart	Gmate	320	89.7%	287	25	4	2	2
90.0%	LifeScan	OneTouch Ultra2	OneTouch Ultra	311	96.8%	301	9	1
92.2%	LifeScan	OneTouch Verio	OneTouch Verio	319	95.6%	305	13	1
90.3%	Prodigy	Prodigy Auto Code	Prodigy No Coding	312	95.8%	299	11	1	1
76.3%	BioSense Medical	SolusV2	SOLUS	320	89.4%	286	34
87.7%	HDI/Nipro	True Result	TrueResult	318	90.9%	289	26	2	1
81.5%	HDI/Nipro	True Track	TrueTrack	205	89.8%	184	19	2
92.3%	Arkray	Walmart ReliOn Prime	ReliOn Prime	312	96.2%	300	12
96.8%	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	317	97.5%	309	8
89.3%	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	319	95.0%	303	14	1	1

Glycolized Sample Results
					Trials Within Protocol Limits
Sort Order	Brand	Blood Glucose Monitor	Test Strip	Valid Trials	N	Percent
98.4%	Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	55	55	100%
95.3%	Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	58	58	100%
75.5%	Diabetic Supply of Suncoast	Advocate Redi-Code +	Advocate	NOT TESTED
88.8%	Bayer	Contour Classic	Contour	57	56	98%
99.7%	Bayer	Contour Next	Contour Next	55	55	100%
96.5%	Agamatrix	CVS Advanced	CVS Advanced	NOT TESTED
88.4%	Omnis Health	Embrace	Embrace No Code	NOT TESTED
95.5%	Abbott	FreeStyle Lite	FreeStyle Lite	53	53	100%
70.6%	Philosys, Inc.	Gmate Smart	Gmate	NOT TESTED
90.0%	LifeScan	OneTouch Ultra2	OneTouch Ultra	NOT TESTED
92.2%	LifeScan	OneTouch Verio	OneTouch Verio	58	58	100%
90.3%	Prodigy	Prodigy Auto Code	Prodigy No Coding	NOT TESTED
76.3%	BioSense Medical	SolusV2	SOLUS	NOT TESTED
87.7%	HDI/Nipro	True Result	TrueResult	53	52	98%
81.5%	HDI/Nipro	True Track	TrueTrack	NOT TESTED
92.3%	Arkray	Walmart ReliOn Prime	ReliOn Prime	NOT TESTED
96.8%	Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	NOT TESTED
89.3%	Abbott	Walmart ReliOn Ultima	ReliOn Ultima	47	46	98%
			Total Data Pairs	436
	BGMSs that use glucose oxidase chemistry are particularly sensitive to oxygen levels. Since glycolysis changes the oxygen concentration of a blood sample, glycolized blood samples were only assayed on BGMSs that specify glucose dehydrogenase chemistry, which is oxygen insensitive. The glucose levels ranged from 11 mg/dL to 80 mg/dL with mean (SD) 49.1 (15.6) mg/dL.

Study Summary
	N	Percent	Meter Readings	Readings Per Reference Value
Non-Glycolized Specimens	1032
Excluded Reference Values^*	81	7.8%
Included	951	92.2%	5584	5.9
No Hematocrit Value	19	2.0%
Hematocrit Out of Range (<33%, >52%)	57	6.0%
Hematocrit in Range^†	875	92.0%	5119	5.9
^†Seal/No Seal did not change when the analysis was restricted to in-range hematocrit.
Glycolized Specimens	185
Excluded Reference Values^‡	13	7.0%
Included	172	93.0%	436	2.5
^*Excluded 63 for > 4% variability between YSI reference runs, 6 for hemolysis, and 12 for other sample problems. ^‡Excluded 7 glycolized specimens for > 4% variability between YSI reference runs, 4 for hemolysis, and 2 for reference values > 80 mg/dL.

Surveillance program documents and Press Releases

June 23, 2017 Press Release: Diabetes Technology Society (DTS) Releases Results of Blood Glucose Monitor System Surveillance Testing

June 8, 2016 Press Release: Testing for BG Monitor Surveillance Program Now Underway

The Surveillance Protocol: Klonoff DC, Lias C, Beck S, Parkes JL, Kovatchev B, Vigersky RA, Arreaza-Rubin G, Burk RD, Kowalski A, Little R, Nichols J, Petersen M, Rawlings K, Sacks DB, Sampson E, Scott S, Seley JJ, Slingerland R, Vesper HW. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2015 Oct 18. pii: 1932296815614587. [Epub ahead of print]

March 3, 2015 Press Release: Announcement of Protocol Completion

December 18, 2014 Press Release: DTS Surveillance Program for Cleared Blood Glucose Monitors: Update on Testing Protocol

November 5, 2014 Meeting Agenda: DTS Cleared Blood Glucose Monitors Surveillance Program: Payer's Meeting

September 15, 2014 Press Release: Diabetes Technology Society: The Surveillance Program

June 12, 2014 Press Release: Diabetes Technology Society (DTS) has assembled the Steering Committee for the DTS Surveillance Program for Cleared Blood Glucose Monitors

May 20, 2014 Press Release: Diabetes Technology Society (DTS) Launches the DTS Surveillance Program for Cleared Blood Glucose Monitors

Meeting Summary Report for May 21, 2013 meeting: Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?

Diabetes Technology Society (DTS) Launches the DTS Surveillance Program for Cleared Blood Glucose Monitors

Foster City, California: May 20, 2014—Diabetes Technology Society (DTS) is pleased to announce the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This program is intended to protect patients from inaccurate BGM products currently on the market. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.

After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post clearance. Low-quality BGM systems can negatively impact the ability of people with diabetes to reliably monitor their blood glucose levels and can lead to adverse health effects. Efforts by the FDA to improve accuracy standards for pre-market clearance would have little impact if performance was not maintained post-market, so a post-market surveillance program is critically important to ensuring the accuracy of cleared products for people with diabetes.

A Steering Committee and an Advisory Committee will be formed consisting of experts in blood glucose monitoring from academia, medical practice, clinical chemistry, government, industry, and medical organizations. Patient advocacy group(s) will be represented. A protocol to assess BGM System performance will be developed and then product testing will begin. It is expected that the information generated by this program will inform patients, payers, and regulators as to which cleared products actually perform accurately in a real world standardized environment.

FDA supports a BGM Surveillance program to protect public health. The agency has agreed with the concept of a surveillance plan and has stated that it will act on information that it receives on low-quality BGM products, including from surveillance testing. Initial funds to get the post-market surveillance program started have been committed by Abbott, the global healthcare company. The project will begin this month.

“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program. I encourage other manufacturers to come forward to join Abbott in support of this program.”

About Diabetes Technology Society

Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishesJournal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of a blood glucose monitor in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.

For additional information, contact Brett McGreevy at Diabetes Technology Society.
650-357-7140(mcgreevy@diabetestechnology.org) (www.diabetestechnology.org)

Diabetes Technology Society (DTS) has assembled the Steering Committee for the DTS Surveillance Program for Cleared Blood Glucose Monitors

Foster City, California: June 12, 2014 - Diabetes Technology Society (DTS) is pleased to announce that the Steering Committee has been assembled for its Surveillance Program for Cleared Blood Glucose Monitors. The first Steering Committee meeting will take place next month in Washington DC.

This program is intended to identify poorly performing blood glucose monitoring products on the market. This surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance. The program will generate information that can assist patients, healthcare providers, and payers in making informed product selections. The information will also be provided to FDA, which is the government agency that regulates these products.

After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post-clearance. Poorly performing BGM system can interfere with the ability of people with diabetes to reliably monitor their blood glucose levels, and make correct decision based upon the readings. Inaccurate readings can lead to incorrect actions and therefore to adverse outcomes. Ongoing efforts by the FDA to improve accuracy standards for pre-market clearance would be undermined if performance was not maintained post-market. Therefore, a post-market surveillance program is critically important to ensure the accuracy of cleared products for people with diabetes.

A Steering Committee has been formed consisting of world class experts in blood glucose monitoring, diabetes, and laboratory methods from academia, medical practice, government, industry, and medical organizations. Many of them have experience in establishing surveillance programs and testing verification programs for other medical tests. Patient advocacy group(s) will be represented in a future Advisory Board that will be established soon. A protocol to assess BGM System performance will be developed and then product testing will begin.

“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and a Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to information that can assist them in selecting more accurate blood glucose meter systems and manufacturers committed to delivering accurate products will have an opportunity to back up claims about quality and accuracy with verification from this independent testing program.”

About Diabetes Technology Society

Diabetes Technology Society is a non-profit educational organization dedicated to promote development and use of technology to help people with diabetes. DTS publishes Journal of Diabetes Science and Technology, the world’s largest scientific journal devoted to new technologies in the fight against diabetes, including glucose monitoring, insulin delivery, the artificial pancreas, software, wireless health solutions, social media, and bioengineered solutions for treating obesity. DTS presents the annual Diabetes Technology Meeting, the Hospital Diabetes Meeting, the Certified Diabetes Technology Clinician certification meeting in the US and in Europe, and the Tissue Response to Implanted Active Medical Devices Meeting. DTS has developed a Personalized Medicine Diabetes Program for the US Air Force. DTS is currently spearheading development of a new error grid for defining clinical accuracy of blood glucose monitors in cooperation with FDA, American Diabetes Association, The Endocrine Society, and Association for Advancement of Medical Instrumentation.
For additional information, contact Brett McGreevy at Diabetes Technology Society.
650-357-7140(mcgreevy@diabetestechnology.org) (www.diabetestechnology.org)

Diabetes Technology Society: The Surveillance Program

Foster City, California: September 15, 2014– Diabetes Technology Society (DTS) is pleased to announce that it will hold apublic meeting regarding payer liability for funding inaccurate blood glucose monitors.This meeting, which is free to attend, is an extension of the DTS Surveillance Program for Cleared Blood Glucose Monitors, which was launched on May 20, 2014. The event will be held onNovember 5, 2014in Bethesda, Maryland, at the Residence Inn Downtown Bethesda.

After a product has been cleared by the Food and Drug Administration (FDA), there is currently no systematic post-market surveillance program available to monitor ongoing product quality. As a result, some patients diagnosed with diabetes are using blood glucose meters that do not perform to the standard of their FDA clearance. These devices can interfere with the patient’s ability to accurately monitor their blood glucose levels, which can lead to incorrect decisions about treatment and therefore adverse health effects.

The surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors and generate information that can assist patients, payers, and healthcare providers in making informed product selections.The meeting onNovember 5, 2014will cover the outcomes and consequences for payers and patients who use products that have not maintained their performance level since being cleared by the FDA. The meeting will include perspectives from payers, clinicians, attorneys, scientists, the FDA, patients, and other members of the diabetes community.

Admission to the meeting onNovember 5, 2014is free; however, registration will be necessary to attend the event as space is limited. To register, please visit:www.diabetestechnology.org/surveillancepayersmeeting.

DTS Surveillance Program for Cleared Blood Glucose Monitors: Update on Testing Protocol

Foster City, California: December 18, 2014 - Diabetes Technology Society (DTS) is pleased to announce the Steering Committee of the DTS Surveillance Program for Cleared Blood Glucose Monitors met in Herndon, Virginia last week to work on the program’s testing protocol. In the coming days the latest version of the protocol will be circulated to the committee members for final approval.

We are excited to reach this stage of developing the protocol and look forward to begin testing.

Best regards,

David C. Klonoff Signature

David C. Klonoff, MD
President, Diabetes Technology Society

Announcement of Protocol Completion

Foster City, California: March 3, 2015 - Diabetes Technology Society (DTS) is pleased to announce that it has completed its work on the protocol of the DTS Surveillance Program for Cleared Blood Glucose Monitors.

Best regards,

David C. Klonoff Signature

David C. Klonoff, MD
President, Diabetes Technology Society

June 8, 2016 - Burlingame, California - Diabetes Technology Society (DTS) is pleased to announce the commencement of testing for the DTS Surveillance Program for Cleared Blood Glucose Monitor systems (BGMS). This program is intended to provide information to patients, healthcare professionals, payers, and regulators about the performance of BGMS products currently on the market.

A Steering Committee consisting of experts in blood glucose monitoring from academia, medical practice, clinical chemistry, government, industry, and medical organizations worked together to create the protocol. The committee engaged in meetings and teleconferences to determine how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy testing studies with marketed BGMS products conducted by qualified clinical and laboratory research sites.

According to David C. Klonoff, M.D., Medical Director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California and Chair of the Steering Committee, "Patients will benefit from reviewing the results of this study, which uses the most rigorous consensus protocol for screening cleared BGMs that has ever been developed. The study will determine which BGMSs, that are among the most widely used in the US, meet strict performance standards which are similar to those which are currently used for regulatory purposes."

Abbott has contributed funding to the program as part of the company’s commitment to people with diabetes.

About Diabetes Technology Society
Diabetes Technology Society (DTS) is a nonprofit organization committed to promoting development and use of technology in the fight against diabetes. The DTS mission is to spearhead collaborative efforts by experts in academia, clinical practice, industry, and government to accelerate development of practical technology for treating, monitoring, diagnosing, and preventing diabetes mellitus and its complications. DTS is also a leader in medical device cybersecurity.

For additional information visit https://www.diabetestechnology.org, or contact Brett McGreevy, Administrator, Diabetes Technology Society,(650) 692-7100,(mcgreevy@diabetestechnology.org).

DIABETES TECHNOLOGY SOCIETY (DTS) RELEASES RESULTS OF BLOOD GLUCOSE MONITOR SYSTEM SURVEILLANCE TESTING

Burlingame, California - June 23, 2017 - As part of the DTS Blood Glucose Monitor System Surveillance Program (Klonoff DC, et al. J Diabetes Sci Technol 2015: 9(4): 895) the accuracy of 18 blood glucose monitoring systems (BGMSs) marketed in the USA was assessed across a wide range of blood glucose levels in the hands of trained professionals. Products selected for testing represented 90% of IMS Rx data, or 90% of Nov 2014 OIG Report of Medicare Mail-order shares; and most retail private label brands. Products were acquired off-the-shelf, independent of the manufacturer. Products were tested according to a protocol that was developed by an expert panel in blood glucose monitoring surveillance testing from the US government, professional organizations, and academia.

The protocol specified that to be compliant a blood glucose value must be within 15% of a reference plasma value for a blood glucose >100 mg/dl and within 15 mg/dl of a reference plasma value for a blood glucose <100 mg/dl. These protocol criteria were similar to: 1) (for all blood glucose levels) the latest ISO standard (ISO15197-2013, "In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus"); and 2) (for a blood glucose >100 mg/dl) the latest FDA guidance (FDA 2016, "Self-Monitoring of Blood Glucose Test Systems for Over-the-Counter Use"). The number of compliant readings needed to pass depended on the number of trials. For a study of 100 trials, at least 91 readings were required to be within 15% or 15 mg/dL of the reference value. The project was supported by a grant from Abbott Diabetes Care.

Three accuracy studies were performed on each of the 18 selected BGM Systems. Approximately 100 specimens were tested for each trial for each BGM System. A total of 1035 subjects participated. A Seal of Approval was awarded to any product that passed all 3 of the 3 studies. 6 of 18 BGMs received a Seal of Approval. These 6 BGMs all achieved an overall compliance rate of 95% or higher. The data is available at:
https://www.diabetestechnology.org/surveillance.shtml

Diabetes Technology Society is a non-profit organization dedicated to promoting the development and use of technology for people with diabetes. DTS presents the Diabetes Technology Meeting, the Digital Diabetes Congress, the International Hospital Diabetes Meeting, and MEDSec: The Internet of Medical Things. DTS spearheaded development of DTSec, the first consensus cybersecurity manufacturer's standard for any medical device. The official journal of DTS is "Journal of Diabetes Science and Technology", the world’s largest scientific journal focused on diabetes technology.

For additional information visit https://www.diabetestechnology.org or contact Angel Payal, Administrator, Diabetes Technology Society: 650-692-7100 <payal@diabetestechnology.org>

David C. Klonoff, M.D., FACP, FRCP (Edin), Fellow AIMBE¹, Joan L. Parkes, PhD², Boris P. Kovatchev, PhD³,
David Kerr, MBChB, DM, FRCPE⁴, Wendy C. Bevier, PhD⁴, Ronald L. Brazg, MD⁵, Mark P. Christiansen, MD⁶,
Timothy S. Bailey, MD, FACE, CPI⁷, Jim H. Nichols, PhD, DABCC, FACB⁸, Michael A. Kohn, MD, MPP⁹

Affiliations

1) Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, California
2) Joan Lee Parkes Consulting Inc, Bristol, Indiana
3) Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia
4) William Sansum Diabetes Center, Santa Barbara, California
5) Rainier Clinical Research Center, Inc, Renton, Washington
6) Diablo Clinical Research, Walnut Creek, California
7) AMCR Institute Inc, Escondido, California
8) Departments of Pathology, Microbiology and Immunology, Vanderbilt University, Nashville, Tennessee
9) Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California

Objectives

Abstracts

Program

Startup Showcase

Travel

Objectives

Abstracts

Program

Blood Glucose Monitoring System Surveillance Program

Congressional diabetes Caucus & HHS Correspondence About DTS BGMS Surveillance Program

Blood Glucose Monitor Surveillance Article

Summary of Results

Demographics

Main Results

Overall Results

Summary of Modified Bland-Altman Comparison

number and percent of values within specified error limits

Summary of Surveillance Error Grid Comparison

Glycolized Sample Results

Study Summary