阅读说明：本技术 用于检测胰岛素治疗的糖尿病患者的基础率问题的方法 (Method for detecting basal rate problems in insulin-treated diabetic patients ) 是由 F·德邦格 L·舒斯特 J·维雷德 R·班科塞格 于 2019-07-15 设计创作，主要内容包括：本发明涉及一种计算机实现方法、一种计算机程序产品和一种系统,用于确定糖尿病患者基础胰岛素率不足。(The present invention relates to a computer implemented method, a computer program product and a system for determining a basal insulin rate insufficiency for a diabetic patient.)

1. A computer-implemented method for determining a diabetic patient basal insulin rate insufficiency in a data processing system having a processor and a memory storing a program, the program causing the processor to perform a method comprising:

a) receiving a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) optionally receiving diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event,

c) determining whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair satisfying a set of predetermined criteria,

d) a glucose value g0 based on each pair x of the at least n pairs of glucose values_xAnd g1_xDetermining a pair value, and optionally determining one or more statistical values based thereon,

e) comparing the paired value or the one or more statistical values to respective one or more thresholds obtained from the memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

2. The method according to the preceding claim, wherein the program causes the processor to perform a method comprising the steps of:

f) automatically outputting on a display or electronically sending to the patient a message with information about the diabetic patient's basal insulin rate insufficiency if in step e) one or more of the respective thresholds are detected to be exceeded or fallen below.

3. The method of any one of the preceding claims, wherein n is 5.

4. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

the glucose value g0 for x_xWith a measurement time stamp t0 within a first predetermined time range of the day obtained from the memory_xAnd the glucose value g of said pair x1_xHaving a glucose value g0 relative to the pair of x glucose values over a first predetermined time period obtained from the memory_xThe measurement time stamp t0_xMeasurement time stamp t1_x，

No diet and/or bolus event information has been received, the diet and/or bolus event information having t0 at the pair of x-glucose values_xAnd t1_xThe time stamp of the event in between,

has not received diet and/or bolus event information having a glucose value g0 relative to the pair x over a second predetermined time period obtained from the memory_xT0_xIs time stamped, and

the glucose value g0 for x_xWithin a predetermined range of glucose values obtained from the memory.

5. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

the glucose value g0 for x_xWith a measurement time stamp t0 between 9 pm and 12 am_xAnd the glucose value g1 of the pair x_xHas a glucose value g0 in said pair x_xThe measurement time stamp t0_xThe measurement time stamp t1 in the next 4 to 10 hours_x。

6. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

the glucose value g1 for x_xWith a measuring time stamp t1 within a predetermined date range obtained from the memory_xPreferably no more than 30 days from the date of outputting on a display or electronically sending to the patient a message with information about the diabetic patient's insufficient basal insulin rate.

7. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

a measured glucose value has not been received, the measured glucose value having a t0 at the pair of x glucose values_xAnd t1_xThe measurement time stamp in between.

8. The method according to any of the preceding claims 2-7, wherein the set of predetermined criteria comprises the following requirements:

the glucose value g0 for x_xIn the range of 100-170 mg/dl,

in this case, step f) comprises: if in step e) it is detected that one or more of the respective thresholds are exceeded, automatically outputting on a display or electronically sending to the patient a message with: the patient experiences a pattern of morning high glucose values, or

The glucose value g0 for x_xIn the range of 80-150 mg/dl,

in this case, step f) comprises: if in step e) it is detected that one or more of said respective thresholds are lower, automatically outputting on a display or electronically sending to said patient a message with: the patient experienced a pattern of morning low glucose values.

9. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

at t0 of the pair of x glucose values_xMeasured glucose values below a predetermined hypoglycemic threshold obtained from the memory have not been received up to 6 hours before.

10. The method according to any of the preceding claims, wherein the set of predetermined criteria comprises the following requirements:

at t0 of the pair of x glucose values_xUp to 48 hours before two or more predetermined hypo-hemorrhages obtained from the memory have not been receivedMeasured glucose value of the glucose threshold.

11. The method according to any of the preceding claims, wherein step d) comprises: determining a difference g1 for each of the at least n pairs of glucose values_x-g0_xAs the pair value, and preferably automatically determining one or more percentiles as the one or more statistical values of the difference value.

12. The method of claim 11, wherein

Step d) comprises automatically determining the 40 th and 25 th percentiles as said one or more statistical values of said difference,

step e) comprises automatically comparing the 40 th percentile with a threshold of 30 mg/dl and the 25 th percentile with a threshold of-30 mg/dl, and

step f) comprises: if the 40 th percentile is above the 30 mg/dl threshold and the 25 th percentile is above the-30 mg/dl threshold, then a message is automatically output on a display or electronically sent to the patient with the following information: the patient experienced a pattern of high glucose values.

13. The method of claim 11, wherein

Step d) comprises automatically determining the 60 th and 75 th percentiles as said one or more statistical values of said difference,

step e) includes automatically comparing the 60 th percentile to a threshold of-30 mg/dl and the 75 th percentile to a threshold of 30 mg/dl, and

step f) comprises: if the 60 th percentile is below the-30 mg/dl threshold and the 75 th percentile is below the 30 mg/dl threshold, a message is automatically output on a display or electronically sent to the patient with the following information: the patient experienced a pattern of low glucose values.

14. A computer program product, preferably stored on a storage medium, configured to perform the method according to any of the preceding claims during operation on a system comprising a processor and a display device.

15. A system for determining a diabetic patient's basal insulin rate insufficiency, the system comprising a processor, a display and a memory having stored thereon a program that causes the processor to execute a method comprising:

a) receiving, by the processor, a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) optionally receiving, by the processor, diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of a diet and/or bolus event,

c) determining, by the processor, whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair of glucose values satisfies a set of predetermined criteria obtained from the memory:

d) a glucose value g0 based on each pair x of the at least n pairs of glucose values by the processor_xAnd g1_xDetermining a pairing value, and optionally determining one or more statistical values by the processor based thereon,

e) comparing, by the processor, the paired value or the one or more statistical values to respective one or more thresholds obtained from the memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

Technical Field

The present invention relates to a computer implemented method, a computer program product and a system for determining a potential deficiency in a basal insulin rate of a diabetic patient.

Background

Diabetes refers to a disease in which the human body's ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and increased levels of glucose in the blood. Symptoms of hyperglycemia include increased urinary frequency, thirst and hunger. Diabetes, if left untreated, causes a number of complications. Acute complications may include diabetic ketoacidosis, hyperosmolar hyperglycemic state, or death. Serious long-term complications include cardiovascular disease, stroke, chronic kidney disease, foot ulcers and eye damage.

Insulin therapy is often an important component of diabetes treatment and can prevent diabetic complications by helping to keep blood glucose within a target range. Mimicking the normal physiological pattern of insulin secretion may be the best way to achieve tight control of blood glucose. Key features of the physiological pattern of insulin secretion by beta cells are the peak of dietary stimulated insulin secretion, which decays slowly over 2 to 3 hours, and a sustained basal level that remains constant throughout the day. These actions of insulin maintain plasma glucose levels within a fairly narrow range.

Basal bolus insulin therapy procedures involve the administration of long-acting insulin to keep blood glucose levels stable during fasting periods, and the injection of short-acting insulin separately to prevent the diet from causing elevated blood glucose levels. The role of basal insulin (also known as background insulin) is to maintain blood glucose levels at a constant level during fasting.

The appropriate basal rate varies from person to person and may vary over time. Due to the non-optimized basal rate, users often end up with high or low glucose readings in the morning, which is strongly associated with elevated HbA1c and diabetic complications.

The basal rate test may help determine whether adjustments to the basal rate are needed. However, conventional basal rate testing as described in the literature requires vigorous patient involvement and must be repeated several times to ensure accurate results.

For example, for testing an overnight basal rate, the babanda health service guide recommends that basal testing be started at least 4 hours after the last meal or bolus of insulin. Blood glucose should then be checked and recorded before bedtime. The patient is further instructed not to eat a snack or to take a bolus. If the glucose is below 4 mmol/l or above 14 mmol/l, the test should be stopped. In this case, the patient should be treated with glucose or given a correction bolus, respectively. In addition, the patient is instructed to measure glucose every 3 hours or more during the night. Whenever glucose is below 4 mmol/l or above 14 mmol/l, the test should be stopped and the patient should treat himself with glucose or insulin, respectively. The test should be run for 2-5 evenings until a pattern is seen (not necessarily for 5 evenings). The blood glucose level should be recorded all the time. To adjust the basal rate, the recorded data should be reviewed and the patient should check the mode. If the blood glucose changes by more than 2 mmol/l, the basal rate needs to be adjusted.

WO 2008/112078 describes a patient insulin management device for managing insulin therapy. The device includes a user interface configured to generate an electrical signal to initiate a basal insulin rate test upon a user prompt. User instructions for the basal insulin rate test may be displayed, including periodically prompting the user to enter a blood glucose value. The controller may cancel the basal insulin rate test if the blood glucose data received during the basal rate test indicates that the patient's blood glucose level is outside of a specified range of blood glucose levels.

Although the patient insulin management device described may alleviate the patient's pain, it still requires the user to actively start the basal rate test and be bothersome to perform the test, and he may not know what to do or become frustrated when the test is aborted.

It is an object of the present disclosure to provide improved techniques for basal rate testing, in particular for determining potential deficiencies in current basal insulin rates.

Disclosure of Invention

This task is solved by the methods and systems provided herein. Particular embodiments that can be realized in a single manner or in any combination are set forth in the dependent claims.

In one aspect, the present invention relates to a computer-implemented method for determining basal insulin rate insufficiency in a diabetic patient in a data processing system having a processor and a memory storing a program that causes the processor to perform a method comprising the steps of:

a) receiving a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) optionally receiving diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event,

c) determining whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair satisfies a set of predetermined criteria:

d) a glucose value g0 based on each of at least n pairs of glucose values for x_xAnd g1_xDetermining a pair value, and optionally determining one or more statistical values based thereon,

e) the pair or one or more statistics are compared to respective one or more thresholds obtained from memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

In another aspect, the invention relates to a computer program product, preferably stored on a storage medium, configured to perform a method comprising, during operation on a system comprising a processor and a display device:

a) receiving a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) optionally receiving diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event,

c) determining whether the plurality of glucose values includes at least n pairsGlucose value g0_{1 to n}And g1_{1 to n}Each pair satisfies a set of predetermined criteria:

d) a glucose value g0 based on each of at least n pairs of glucose values for x_xAnd g1_xDetermining a pair value, and optionally determining one or more statistical values based thereon,

e) the pair or one or more statistics are compared to respective one or more thresholds obtained from memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

In another aspect, the invention relates to a system for determining basal insulin rate insufficiency in a diabetic patient, the system comprising a processor, a display and a memory having stored thereon a program that causes the processor to execute a method comprising the steps of:

a) receiving, by a processor, a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) receiving, optionally by a processor, diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event,

c) determining, by a processor, whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair of glucose values satisfies a set of predetermined criteria:

d) a glucose value g0 based on each of at least n pairs of glucose values for x by the processor_xAnd g1_xDetermining a pairing value, and optionally determining one or more statistical values by a processor based thereon,

e) comparing, by the processor, the pair value or the one or more statistics with the respective one or more thresholds obtained from the memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

If in step e) one or more of the respective thresholds are detected to be exceeded or fallen below, a message with information about the diabetic patient's basal insulin rate insufficiency is automatically output on a display or electronically transmitted to the patient. .

Detailed Description

As used hereinafter, the terms "having," "including," or "containing," or any grammatical variants thereof, are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context, in addition to the features introduced by these terms, as well as the presence of one or more other features. As an example, the expressions "a has B", "a includes B" and "a includes B" may all refer to the following: except for B, there is no other element in a (i.e., the case where a is composed of B individually and uniquely), and the following may be referred to: in addition to B, one or more other elements are present in entity a, such as element C, elements C and D, or even other elements.

As mentioned above, in a first embodiment, the present invention is directed to a computer-implemented method for determining a basal insulin rate insufficiency for a diabetic patient in a data processing system having a processor and a memory storing a program that causes the processor to perform a method comprising the steps of:

a) receiving a plurality of measured glucose values, wherein each glucose value is associated with a measurement timestamp indicating a respective time and date of the measurement,

b) optionally receiving diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event,

c) determining whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair satisfies a set of predetermined criteria:

d) a glucose value g0 based on each of at least n pairs of glucose values for x_xAnd g1_xDetermining a pair value, and optionally determining one or more statistical values based thereon,

e) the pair or one or more statistics are compared to respective one or more thresholds obtained from memory, wherein one or more of exceeding or falling below the respective thresholds indicates that the diabetic patient has insufficient basal insulin rate.

In one embodiment, the program causes the processor to perform a method further comprising:

f) if in step e) one or more of the respective thresholds are detected to be exceeded or fallen below, a message with information about the diabetic patient's insufficient basal insulin rate is automatically output on a display or electronically transmitted to the patient.

The methods of the present invention provide a method for readily determining a basal insulin rate deficiency (also referred to herein as "deficiency") in a diabetic patient. In order to perform the method of the invention, the patient does not need any knowledge of the basal insulin rate test (shortly: basal test) and does not need to pay attention to the basal test guidelines. The patient does not need to set an alarm for the test to be performed at night and the situation where the patient is frustrated by aborting the test is avoided because the patient does not even need to know that the basic test was performed for him. The method can be carried out in an automated manner, so that at least for steps c) to e) or c) to f) no user interaction with a computer implementing the method is required. The method of the present invention may also be viewed as a test of whether other, non-automated, basic tests should be conducted in which the patient follows certain criteria strictly and consciously.

In one embodiment, the method of the present invention includes informing the patient whether the basal insulin rate is too low or too high. The method of the present invention may further comprise calculating an insulin therapy recommendation and outputting the recommendation on a display or electronically transmitting the recommendation to the patient.

The method of the present invention may be implemented on a diabetes management device. The diabetes management device may be or may comprise, for example, a blood glucose meter, an insulin pump or a mobile phone. The diabetes management device may receive measured glucose values, each associated with a measurement timestamp, via wired transmission or wirelessly from, for example, a blood glucose meter (for field monitoring) or a continuous glucose monitoring device. The diabetes management device may further receive meal and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the meal and/or bolus event. Information associated with event timestamps indicating respective times and dates of meal and/or bolus events may be entered manually or received via wired transmission or wirelessly from, for example, a pump or pen or other device. Data (such as measured glucose values, dietary event information, bolus information) may be received in real-time or delayed. In the present invention, the term "basal insulin rate" or "basal rate" refers to insulin delivered by a pump as well as long-lasting insulin injected by a pen.

In step c) of the method of the invention, it is determined whether the plurality of glucose values comprises at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair satisfying a set of predetermined criteria. In one embodiment, this means that in one embodiment each of the at least n pairs of glucose values meets the following criteria: glucose value for x g0_xGlucose value g1 for x satisfying a first set of predetermined criteria_xA second set of predetermined criteria is satisfied. In one embodiment, in step c) of the method of the invention, it is determined whether the plurality of glucose values includes a glucose value having an associated respective measurement timestamp t0_1-5And t1_1-5At least 5 (or 7 or 10) to glucose value g0_1-5And g1_1-5Each pair meets a set of predetermined criteria, i.e., it is determined whether the plurality of glucose values includes at least 5 pairs of glucose values (with associated respective measurement timestamps t 0)₁、t1₁；t0₂、t1₂；t0₃、t1₃；t0₄、t1₄；t0₅、t1₅G0₁、g1_1；g0₂、g1₂；g0₃、g1₃；g0₄、g1₄；g0₅、g1₅) Each pair (with associated respective measurement timestamp t0₁、t1₁；t0₂、t1₂；t0₃、t1₃；t0₄、t1₄；t0₅、t1₅G0₁、g1₁；g0₂、g1₂；g0₃、g1₃；g0₄、g1₄；g0₅、g1₅) A set of predetermined criteria is met.

Using the method of the present invention, the patient does not need to specifically measure and collect glucose values in order to conduct a basal insulin test, but the method of the present invention advantageously utilizes any available data that a diabetic patient typically collects to check whether the plurality of data collected "occasionally" contains a sufficient number of suitable data pairs for assessing the patient's basal insulin rate.

The appropriate data pairs may be identified based on predetermined criteria obtained from the memory of the system.

In one embodiment of the method of the present invention, in step c), it is determined whether the plurality of glucose values comprises at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair of glucose values fulfils at least the following criteria as a predetermined set of criteria:

glucose value for x g0_xWith a time stamp t0 within a first predetermined time range of the day obtained from memory_xAnd a glucose value for x g1_xHaving a glucose value g0 relative to the x glucose value over a first predetermined time period obtained from memory_xTime stamp t1 of time stamp_x,

No diet and/or bolus event information has been received having a glucose value at t0 of the pair_xAnd t1_xThe time stamp of the event in between,

has not received diet and/or bolus event information having a glucose value g0 relative to x over a second predetermined time period obtained from memory_xT0_xIs time stamped, and

glucose value for x g0_xWithin a predetermined range of glucose values obtained from memory.

For example, it is thus ensured that the pair used for assessing the basal insulin rate comprises a suitable fasting value, and that no or hardly any fast-acting insulin is present in the patient when the glucose value is taken into account in the method of the invention for determining that the basal insulin rate is insufficient.

In one embodiment, the set of predetermined criteria includes the following requirements:

glucose value for x g0_xWith a measurement time stamp t0 between 9 pm and 12 am_xAnd a glucose value for x g1_xHaving a glucose value g0 in pairs x_xMeasurement time stamp t0_xThe measurement time stamp t1 in the next 4 to 10 hours_x。

This will be targeted for basal rate testing during overnight fast.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

glucose value for x g1_xHaving a measurement timestamp within a predetermined date range obtained from memory, preferably no more than 30 days from the date the message with information about the diabetic patient's basal insulin rate insufficiency is output on a display or electronically sent to the patient.

Thereby, it may be further ensured that the most recent data is taken into account for the evaluation of the basal insulin rate.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

no measured glucose value has been received, having a value at t0 for x glucose values_xAnd t1_xThe measurement time stamp in between.

If the received timestamp is between t0 for the x-glucose value_xAnd t1_xMeasured glucose value in between, which may for example indicate that the patient is at t0_xAnd t1_xThere is an error between or the patient is on x glucose t0_xAnd t1_xIn between food consumption or insulin injection (bolus) which may not be properly entered as a diet and/or bolus event in his diabetes management device.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

glucose value for x g0_xIn the range A or in the range B different from A

And when range a is deemed to be the requisite range, step f) comprises automatically outputting on a display or electronically sending to the patient a message with information that, if in step e) it is detected that one or more of the respective thresholds are exceeded, the patient is subjected to a pattern of morning high glucose values,

when, however, range B is deemed to be the requisite range, step f) comprises automatically outputting on a display or electronically sending a message to the patient with information that the patient is experiencing a morning low glucose value mode if in step e) a drop below one or more of the respective thresholds.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

glucose value for x g0_xIn the range of 100-170 mg/dl

In this case, step f) comprises automatically outputting on a display or electronically sending to the patient a message with information, i.e. if in step e) it is detected that one or more of the respective thresholds are exceeded, the patient experiences a pattern of morning high glucose values.

Or

Glucose value for x g0_xIn the range of 80-150 mg/dl,

in this case, step f) comprises automatically outputting on a display or electronically sending to the patient a message with information that the patient is experiencing a pattern of morning low glucose values if in step e) a drop below one or more of the respective thresholds is detected.

In this way, it is possible in particular to ensure that the basal rate is evaluated on the basis of the glucose value pairs with the glucose value g0 in the range. Using separate criteria for informing the patient of the pattern of high or low glucose values in the morning he experiences further allows providing a basal rate test for many situations but keeps the risk of making a determination that may lead the patient to draw a wrong conclusion at a lower level. For example, the requirement to use only an allowable range of 100-150 mg/dl as the effective g0 value would mean that the patients to which the method is accessible are limited (not so many patients will always go to bed with these ideal values). However, if only a wide range of 80-170mg/dl is used and the patient is informed of the morning high point, this may lead the patient to conclude that it is appropriate to inject more insulin. This may result in the patient falling below the undesirable 70 mg/dl. Therefore, it is advantageous to use a separate g0 standard to inform the patient of a pattern of high or low morning glucose values.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

at t0 for x glucose value_xNo measured glucose value below the predetermined hypoglycemic threshold obtained from the memory has been received up to 6 hours before.

In one embodiment of the invention, the set of predetermined criteria includes the following requirements:

at t0 for x glucose value_xTwo or more measured glucose values below the predetermined hypoglycemic threshold obtained from the memory have not been received up to 48 hours before.

Thus, erroneous determinations due to hormonal counter-regulation due to strong hypoglycemia can be avoided. The hypoglycemic threshold may be defined, for example, as 60 mg/dl.

In one embodiment of the invention, step d) includes determining the difference g1 for each of at least n pairs of glucose values_x-g0_xAs a pair value, and preferably automatically determining one or more percentiles as one or more statistical values of the difference. Step d) may, for example, comprise automatically determining the 40 th and 25 th percentiles as one or more statistical values of the difference, step e) may comprise automatically comparing the 40 th percentile with a threshold value of 30 mg/dl and the 25 th percentile with a threshold value of-30 mg/dl, and step f) may comprise automatically outputting on a display or electronically sending a message to the patient with information, i.e. if the 40 th percentile is higher than 30 mg +A threshold of dl, and the 25 th percentile is above the threshold of-30 mg/dl, the patient experiences a pattern of high glucose values. As another example, step d) may include automatically determining the 60 th and 75 th percentiles as one or more statistics of the difference, step e) may include automatically comparing the 60 th percentile to a threshold of-30 mg/dl and the 75 th percentile to a threshold of 30 mg/dl, and step f) may include automatically outputting on a display or electronically sending a message to the patient with information that the patient experienced a mode of low glucose values if the 60 th percentile is below the threshold of-30 mg/dl and the 75 th percentile is below the threshold of 30 mg/dl.

More particularly, in one embodiment of the invention, n is 5, and the following rules are used to inform the patient of the pattern of high or low glucose values in the morning:

	morning _ high	Morning _ Low
			Rules	Morning _ high = P40>30 mg/dl and P25> -30 mg/dl	Morning _ low = P60<-30 mg/dl and P75< 30 mg/dl

In other words, for this embodiment, a glucose value of at least 5 pairs "valid" would be required. From these values, the indicated percentile (Pxx) of the difference values (g1-g0) calculated for each pair is used for classification. A percentile is a metric used in statistics that indicates a value that is lower than a given percentage of observations in a set of observations. For example, the 40 th percentile (P40) is the value (or score) below which 40% of observations can be found.

Whether the plurality of glucose values includes at least n pairs of glucose values g0 may be automatically performed at a predetermined point in time_{1 to n}And g1_{1 to n}Each pair of glucose values satisfies a set of predetermined criteria. Alternatively, the data processing system may receive a request to perform step c) (and further steps d) -f)).

In one embodiment, the method of the present invention includes determining whether a new pair of glucose values g0 and g1 is received that meets a predetermined set of criteria, and wherein step c) is performed automatically if a new pair of glucose values g0 and g1 is detected.

In the method of the present invention, diet and/or bolus event information may be received, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event. For example, information associated with event timestamps indicating respective times and dates of diet and/or bolus events may be manually entered in the diabetes management device, or the information may be received via wired transmission or wirelessly from, for example, a pump or pen or other device. In one embodiment of the invention, information about the diabetic's basal insulin rate insufficiency is automatically output on a display or a message is electronically sent to the patient only if at least 3 diet and/or bolus event information and/or at least 3 measured glucose values have been received per day for a predetermined number of days within a predetermined date range.

This may ensure that the patient normally properly records diet and/or bolus event information and frequently measures glucose values, which increases the reliability of determining that the basal rate is insufficient.

The various embodiments mentioned above with respect to the method may be applied to the system accordingly.

Hereinafter, the present invention will be described in further detail with reference to various examples by way of example. These examples are not intended to limit the scope of the invention, but to provide a further understanding of the invention.

The figures show:

fig. 1, a schematic diagram of a data processing apparatus,

fig. 2, a schematic diagram of a process for operating the apparatus,

fig. 3, a schematic illustration of glucose data received by a patient and determination of a nighttime basal pattern.

Fig. 1 shows a schematic diagram of a data processing device 1 (also referred to herein in various embodiments as a "data processing system" or "system") for determining a basal insulin rate insufficiency of a diabetic patient. The device 1 generally comprises a human machine interface 2, a memory 3 for storing machine-readable instructions, and a processor 4 connected to the human machine interface 2 and the memory 3. The device may comprise one or more functional modules or elements 5, such as interfaces for wireless data transmission.

Machine readable instructions are provided that are executed for determining a basal insulin rate insufficiency for a diabetic patient. Various embodiments of systems and methods for determining basal insulin rate insufficiency are described in more detail herein.

The processor 4 may be a controller, an integrated circuit, a microchip, a computer, or any other computing device capable of executing machine-readable instructions. The memory 3 may be a RAM, ROM, flash memory, hard drive, or any device capable of storing machine-readable instructions.

The device 1 may be provided in any kind of data system configured for electronic data processing.

In the embodiments described herein, the device 1 may be implemented, for example, via cloud or network based technologies, for example, in a blood glucose meter, a drug delivery device, a mobile phone, a Portable Digital Assistant (PDA), a mobile computing device (such as a laptop, tablet, or smartphone), a desktop computer, or a server. It should be understood that in at least one embodiment of a mobile computing device that may be used in one or more embodiments disclosed herein, such a device may contain a touch screen and computing capabilities to run computing algorithms and/or processes (such as those disclosed herein) and application programs (such as email programs), a calendar program to provide a calendar, and one or more functions in providing a cellular connection, a wireless connection, and/or a wired connection, along with a blood glucose meter, a digital media player, a digital camera, a video camera, a GPS navigation unit, and a web browser that can access and properly display web pages. Thus, the system may comprise a plurality of components. The system may also utilize distributed computing devices to execute any or machine readable instructions described herein.

In one embodiment, device 1 may be implemented in a personal computer or a mobile device, e.g., a smartphone. In this and other embodiments, the plurality of measured glucose values is transmitted from the meter to the smartphone via wireless or wired data transmission. The meal and/or bolus events may be directly entered into the smartphone or transmitted to the smartphone from another device via wireless or wired data transmission.

The device further comprises a human-machine interface 2 communicatively coupled to the processor 1 for presenting graphical, textual and/or auditory information. The human machine interface 2 may comprise an electronic display, for example, a liquid crystal display, a thin film transistor display, a light emitting diode display, a touch screen, or any other device capable of converting signals from a processor into a light output; or contain a mechanical output such as a speaker, printer for displaying information on media, etc.

Embodiments of the present disclosure also include machine-readable instructions comprising logic or algorithms written in a programming language (e.g., a machine language or assembly language directly executable by a processor, an Object Oriented Programming (OOP) language, a scripting language, a microcode language, etc.), which may be compiled or assembled into machine-readable instructions and stored on a machine-readable medium. Alternatively, logic or algorithms may be written in a Hardware Description Language (HDL), such as via a Field Programmable Gate Array (FPGA) configuration or Application Specific Integrated Circuit (ASIC), and equivalents thereof. Thus, the machine-readable instructions may be implemented in any conventional computer programming language as pre-programmed hardware elements or as a combination of hardware and software components. Further, the machine-readable instructions may be distributed over various components communicatively coupled (e.g., via a wire, via a wide area network, via a local area network, via a personal area network, etc.). Thus, any of the components of the system can transmit signals over the internet or world wide web.

According to embodiments described herein, the processor 4 of the device 1 may execute machine readable instructions for determining a basal insulin rate insufficiency for a diabetic patient.

Fig. 2 shows a schematic diagram of a block diagram of a method for determining a basal insulin rate insufficiency for a diabetic patient.

In step 20, a plurality of measured glucose values are received in the data processing device 1, wherein each glucose value is associated with a measurement time stamp indicating a respective time and date of the measurement. The plurality of measured glucose values may be received via an interface for wireless data transmission. Optionally, step 20 further comprises receiving in the data processing device 1 diet and/or bolus event information, wherein each of the event information is associated with an event timestamp indicating a respective time and date of the diet and/or bolus event.

In step 21, it is determined whether the plurality of glucose values includes at least n pairs of glucose values g0_{1 to n}And g1_{1 to n}Each pair of glucose values satisfies a set of predetermined criteria.

In step 22, a glucose value g0 based on each of at least n pairs of glucose values for x_xAnd g1_xA pairing value is determined. Optionally, one or more statistical values are also determined based thereon. For example, the difference g1 for each x of at least n pairs of glucose values_x-g0_xA pair value is determined and one or more percentiles are determined as one or more statistics of the difference.

In step 23, the paired values or one or more statistical values are compared to respective one or more threshold values obtained from a memory, wherein exceeding or falling below one or more of the respective threshold values indicates that the diabetic patient has insufficient basal insulin rate. If one or more of the respective thresholds are detected to be exceeded or fallen below, information about the diabetic patient's basal insulin rate insufficiency may be automatically output on a display or a message with information about the diabetic patient's basal insulin rate insufficiency may be electronically sent to the patient via an output device.

Fig. 3 shows a schematic diagram of a plurality of measured glucose values of a patient received based on-site glucose monitoring data over a number of 24 hour time periods. Event/bolus information (not shown in fig. 3) is also received for the patient. The glucose data was scaled according to the time abscissa extension over 24 hours. For example, the last 30 days of patient data are reviewed for finding glucose value pairs that meet a predetermined set of criteria (inclusion and exclusion criteria). The set of predetermined criteria is set to increase the likelihood that these findings are indeed the result of the underlying problem. The matching pairs that meet a predetermined set of criteria are highlighted in fig. 3. In this case, pairs of glucose values have been found that meet a set of predetermined criteria, which show an increase in glucose every night, while for this patient no conflicting data points are found. In this case, it is indicated that there is a problem with the basal insulin treatment regimen. This will trigger information to be sent to the patient, highlight trends and possibly also indicate reasons and next steps.

The present invention is not limited to the particular methodology and protocols described herein because they may vary. Although methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred methods and materials are described herein. Furthermore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention.