1. Preliminary Proposal For Insulin Pump Standards
Standards to improve insulin pump use and medical outcomes
These proposals are not yet final but are made available for review and editorial comment. Any suggestions you have for improvements or changes, or for additional approaches to improve diabetes care are welcomed. Any major contributions will be attributed.

2. These Standards Are Supported By:
John Walsh, PA, CDE, and Ruth Roberts, MA
You (#4,6)*
* Any reservations you have about a particular standard will be noted

3. Review Definitions
TDD – total daily dose of insulin (all basals and boluses)
Basal –background insulin pumped slowly through the day to keep BG flat
Bolus – a quick surge of insulin as
Carb boluses to cover carbs
Correction boluses to lower high readings that arise from too little basal insulin delivery or insufficient carb boluses
Bolus On Board (BOB) – the units of bolus insulin or glucose-lowering activity still working from recent boluses
Duration of Insulin Action (DIA) – time that a bolus will lower the BG. This is used to calculate BOB.

4. The Role Of Insulin Pumps
Insulin pumps should
Lower A1c and eAG levels
Decrease the frequency and severity of hypoglycemia
Provide safe and reliable insulin dosing to users
Reduce complications
Improve quality of life

5. Proposal For Insulin Pump Standards
These standards to improve pump use and outcomes are designed to:
Reduce inconsistencies in pump settings between pump manufacturers
Improve the accuracy and safety of carb and correction factors in use
Improve safety of DIA time increments and defaults that are in use
Consistently account for and apply BOB
Improve monitoring and identification of infusion set failure
Improve monitoring of hypoglycemia & hyperglycemia
Identify excessive use of correction boluses
Reduce blind bolusing and non-entry of glucose values into pumps

6. Review Inconsistent Dosing From Insulin Pumps
There are several significant sources for error in bolus doses from today’s insulin pumps.
Widespread use of inaccurate carb factors
Excessively large carb factor increments
Widespread use of inaccurate correction factors
Wide variations in how BOB is handled and in DIA default times between pump manufacturers
Wide variations in DIA defaults between pump manufacturers

7. Intellectual Property1
Issue: Optimal glucose values for those who have diabetes is critical to prevention of disability and early death. Devices owned and used by those with diabetes contain unique information that can be used to improve control and reduce complication risks.

8. Standard For: Intellectual Property1
Standard For: Intellectual Property
We recommend that all existing and future patents that may contribute to improvements in glucose control be made available at a reasonable cost to any device manufacturer who wants to use them to improve glucose control.

9. Carb Factor (CarbF) Increments2
Issue: Current carb factor increments are too large for smaller carb factor numbers. This lack of precision for carb boluses may create excess hyperglycemia or hypoglycemia for many pump users.

10. Example Carb Factor Increments2
Most pumps offer 1 gram per unit as their smallest CarbF increment. This increment becomes relatively large for CarbFs below 15 or 20 g/u. For instance, when the carb factor is reduced from 10 to 9 g/u, all subsequent carb boluses are increased by 11.1% in most pumps.
A shift in the carb factor from 1u/5g to 1u/4g causes each subsequent carb bolus to increase by 25%.
When carb boluses make up 50% of the TDD, a change in the a carb factor larger than 2.5% would be expected to create more than a 25 mg/dl shift in the glucose following each meal.
Finer CarbF increments would allow safer and more precise adjustment of subsequent carb boluses.
Example: TDD = 40u, carb factor ~1u/11g, corr factor ~1u/60 mg/dl
carb boluses = 20u or ~6u/meal x 6% =.36u x 60 = a 22 mg/dl change in BG

11. What Current Changes In CarbFs Do2
Table shows how a one-step reduction in the CarbF using various CarbF increments affect the size of subsequent carb boluses. Yellow area shows impact from most pumps. Green (preferred) areas show increments that impact subsequent boluses less than 5%.

12. Example Impact On BG From CarbF Adjustments2
This table shows the average additional fall in glucose that is likely after each meal of the day when a carb factor is reduced from 10 grams per unit to 9 grams per unit (for appropriate weight & TDD), and again a reduction from 5 grams per unit to 4 grams per unit.
How A 1-Step Reduction In Carb Factor Impacts Avg. Meal BG
Change in CarbF
Typical weight
Carb/day
Avg carb gms/meal
Increased units/meal
Additional BG fall per meal*
1/10 to 1/9
160 lb
220 gr
73 gr
+ 0.9 u
- 40 mg/dl
1/5 to 1/4
240 lb
330 gr
110 gr
+ 5.5 u
- 124 mg/dl
Calculated as carb grams per day X increase in avg. carb bolus size 3

13. Carb Factor Increments2
Standard For:
Carb Factor Increments
We recommend that carb factor increments be small enough that a single step adjustment in a factor causes subsequent carb boluses to change by no more than 5% from previous bolus doses for the same number of grams of carb.

14. Inaccurate Carb Factors3
Issue: A carb factor that does not match the individual using it will significantly magnify other sources of error in the calculation of carb bolus doses. Many carb factors used in insulin pumps today are poorly tuned to users.

15. Review Actual Carb Factors In Use 13
Avg. carb factors* for 468 consecutive Cozmo insulin pump downloads (>126,000 boluses) are shown in blue
Note that they are NOT bell-shaped or physiologic
People prefer “magic” numbers – 7, 10, 15, and 20 g/unit – for their carb factors
* Determined directly from grams of carb divided by carb bolus units for each carb bolus 10 7
115 20 1

16. Review Actual Carb Factors In Use 13
MANY magic carb factors, shown in blue, are inaccurate. A more normal or physiologic distribution is shown in green
Use of magic numbers creates major, though consistent bolus errors that magnify other sources of error 10 7
115 20 1

17. Standards For: Carb Factor Settings 3
To encourage use of consistent and accurate carb factors in pumps, we request that insulin pump companies jointly determine what range of carb factor rule numbers (CarbF x TDD) provide optimal glucose results that lead to a lower eAG and less hypoglycemia for various TDD ranges and carb intakes as a percentage of calories.
We request that insulin pump companies measure and publish each year the carb factors in use for 200 random downloads from pumps that use carb factors. This information is needed as an overview to guide interventions directed at reducing errors in carb factor settings.
We recommend that carb factors be monitored within each pump for accuracy and effectiveness with a report available to users or clinicians.

18. Example Carb Factor Settings3
To assist users in setting accurate CarbFs, insulin pumps should allow the user to compare their current CarbF against an optimal settings range of CarbF Rule Numbers. Proposed CarbF Rule Numbers for various TDDs:
Proposed Rule # Ranges For Recommending Carb Factors *
Carb Factor Rule Number Range
Avg. TDD
More aggressive
Less aggressive
40 u or less
400
500
40 to 80 u
425
600
Over 80 u
650
* Optimal ranges would be determined from research studies of best practices

19. Inaccurate Correction Factors4
Issue: A correction factor that does not match the individual using it will significantly magnify other sources of error in the calculation of correction bolus doses. Many correction factors used in insulin pumps today are poorly tuned to users.

20. Review Actual Correction Factors In Use 14
Avg. correction factors in use for 452 consecutive Cozmo insulin pump downloads
Like carb factors, correction factors in use are NOT bell-shaped or physiologic
Users or clinicians often select “magic” numbers for their correction factors. 10 7
115 20 1

21. Correction Factor Settings4
Standards For:
Correction Factor Settings
To encourage use of consistent and accurate correction factors in pumps, we request that insulin pump companies jointly determine what range of correction factor rule numbers (CorrF x TDD) provide optimal glucose results that lead to a lower eAG and less hypoglycemia for various TDD ranges, and publish them for users and clinicians to use.
We request that insulin pump companies voluntarily measure and publish each year the correction factors in use for 200 consecutive downloads from pumps that use correction factors.
We recommend that correction factors be monitored within each pump for accuracy and effectiveness with a report available to users or clinicians.

22. Example Correction Factor Settings4
To assist users in setting accurate CorrFs, insulin pumps should allow the user to compare their current CorrF against an optimal settings range of CorrF Rule Numbers. Proposed CorrF Rule Numbers for various TDDs:
Proposed Rule # Ranges For Recommending Corr. Factors*
Correction Factor Rule Number Range
Avg. TDD
More aggressive
Less aggressive
40 u or less
1700
2000
40 to 80 u
1800
2200
Over 80 u
2400
* Optimal ranges would be determined from research studies of best practices

23. Basal/Carb Bolus Balance5
Issue: Correction boluses are used to correct for deficits in insulin that arise from inadequate basal delivery or inadequate carb boluses. Because the reason for their use cannot be clearly identified as basal or bolus, they should not be included in basal/bolus balance.

24. Standard For: Basal/Carb Bolus Balance5
Standard For: Basal/Carb Bolus Balance
We propose that basal/carb bolus balance is a more definitive term and should replace basal/bolus balance. Basal/carb bolus balance should NOT include correction bolus doses which will be listed separately to more clearly define and understand control issues.

25. Example Basal/Carb Bolus Balance5
How a pump might display insulin information:
TDD = 40.0 u in last 7 days:
% of TDD units
Basal 30% 12 u
Carb boluses 50% 20 u
Corr. boluses 20%(+12%) 8 u (+ 4.8 u)
Basal/Carb bolus balance = 0.6 (12u/20u) or 60%. This particular imbalance would typically favor adding more of the correction bolus excess to basal delivery.

26. Duration Of Insulin Action Default Times6
Issues:
The default DIA times in current pumps vary widely between 3 and 6 hours*
Many users shorten their default DIA to increase the size of their boluses without realizing that this introduces significant errors into bolus (and ultimately basal) doses.
* DIA times that are too short hide bolus insulin activity and create insulin stacking. DIA times that are too long overestimate bolus activity.

27. Standard For: Duration Of Insulin Action (DIA) Time6
Standard For: Duration Of Insulin Action (DIA) Time
We recommend that a panel of experts in insulin action review existing pharmacodynamic studies, consider differences between pharmacodynamics and DIA time, and provide guidance on an acceptable range of DIA times to recommend to clinicians and users to improve the accuracy of bolus calculations.

28. DIA Time Increments 7
Issue: Current DIA time increments vary from 15 minutes to 1 hour in different pumps
When a DIA time is changed in a pump, a larger time increment, such as 1 hr, can create an excessive change in subsequent estimates of BOB.
For example, when the DIA is reduced from 5 hours to 4 hours, subsequent BOB estimates are decreased, while recommendations for carb boluses would increase.

29. Review Glucose Infusion Rate (GIR) Studies7
Most GIR studies suggest that pharmacodynamic action of insulin varies about 25% between individuals. For a DIA time of 5 hr, a 25% range is equivalent to 1 hr and 15 min, such as from 4 hrs and 15 min to 5hr and 30 min.
A pump that has only 1 hr DIA increments would enable the user to select only one setting within a physiologic range, while a 30 min increment would allow only 2 or 3 choices that are close to a physiologic range.

30. 7 Standard For: DIA Time Increments
For safety and accuracy, we recommend that DIA time increments be no greater than 15 minutes to allow more accurate estimation of residual BOB.

31. Review Bolus On Board (BOB)8
Review Bolus On Board (BOB)
An accurate measurement of the glucose-lowering activity that remains from recent boluses helps:
Prevent insulin stacking
Improve bolus accuracy
Allows the current carb or insulin deficit to be determined
aka: insulin on board, active insulin, unused insulin*
* Introduced as Unused Insulin in 1st ed of Pumping Insulin (1989)

32. Example An Accurate BOB Can Avoid Insulin Stacking8
Example An Accurate BOB Can Avoid Insulin Stacking
Bedtime BG = 173
Is there an insulin or a carb deficit?
Bolus insulin stacking becomes a problem because boluses are so easy to give. After a bolus for dinner, one for dessert, another for the high blood sugar two hours after dinner, how much active insulin remains at bedtime?
Bedtime BG
= 173 mg/dl
Correction
Dessert
Dinner
6 pm
8 pm
10 pm
12 am

33. Review Insulin Stacking Is Common8
CDA1 Study Results
Of 201,538 boluses, 64.8% were given within 4.5 hrs of a previous bolus
An accurate DIA shows that some BOB is present for MOST boluses
Note that 4.5 hours may underestimate true DIA
4.5 hrs

34. Review How Current Pumps Handle BOB8
What’s In the BOB & What Is It Applied Against?
BOB Includes This Type Of Bolus
BOB Is Subtracted From This Type Of Bolus
Carb
Correction
Animas 2020
Yes
No*
Deltec Cozmo
Insulet Omnipod No
Medtronic Paradigm
* Except when BG is below target BG

35. Example Bolus Recommendations Differ Significantly8
Example Bolus Recommendations Differ Significantly
Situation: BOB = 3.0 u and 30 gr. of carb will be eaten at these glucose levels
Carb factor = 1u / 10 gr
Corr. Factor = 1 u / mg/dl over 100
Target BG = 100
TDD = ~50 u
The graphic shows how widely bolus recommendations vary from one pump to another for the same situation.
units
mg/dl
Omnipod bolus cannot be determined - it counts only correction bolus insulin as BOB

36. Example Unsafe BOB Handling8
If a pump user gets frustrated with high BGs and they overdose to speed the drop in their BG, or they exercise longer or more intensely than they anticipated, they can acquire a significant excess in BOB.
In this situation, most pumps bolus for all carb intake regardless of how much BOB is present. A subsequent bolus will deliver an excess of insulin if the glucose is not high enough to offset the excess BOB.1
This introduces a significant risk for hypoglycemia from the pump’sexcessive bolus recommendations.
1 Pumping Insulin, 1st ed, 1989, Chap 12, pgs 70-73: The Unused Insulin Rule

37. Current BOB Handling 8
Issue: Most bolus calculators in current insulin pumps assume that excess BOB does not need to be taken into account when determining the next carb bolus.
Because of the way they are determined, bolus dose recommendations from most pumps can cause unexplained and unnecessary insulin stacking and hypoglycemia.

38. Standard For: BOB Handling8
Standard For: BOB Handling
For safe and accurate BOB measurement, we recommend that:
BOB include all carb and correction boluses
Residual BOB be subtracted from both carb and correction bolus recommendations delivered within the DIA*
* Assumes that the DIA time chosen by the clincian or user is accurate.

39. BOB Handling 8 Exception to usual BOB handling:
When a second bolus is taken for unplanned carb intake or desert that is consumed within 60 minutes or so* of a meal bolus, BOB should not be taken into account for the second bolus because the impact of the first bolus cannot be accurately determined.
Given that, it is wise to account for BOB as soon after a meal as possible, such as within 60 to 90 minutes (adjustable), to provide early warning if the bolus given was excessive or inadequate.
It is always safer, though not always more accurate, to account for and apply all BOB in subsequent boluses.
* Adjustable

40. Blind Bolusing 9
Issue: Pump users often bolus for carbs without checking their glucose first. With no glucose reading, the pump does not account for BOB that may be present at the time, and the bolus is not appropriately adjusted for potentially high or low glucose levels.
Blind bolusing often leads to insulin stacking.

41. Standard For: Blind Bolusing9
Standard For: Blind Bolusing
We recommend that insulin pumps alert* the wearer when there is sufficient insulin stacking to introduce a significant error in a current bolus.
* Adjustable for an expected mg/dl drop in glucose with visible, audio, or vibratory output.

42. Example Insulin Stacking or BOB Alert9
When a carb bolus is planned without a recent BG check, but BOB is more than 1.25% of the average TDD (enough to cause about a 25 mg/dl drop in the glucose), the pump will recommend that the wearer do a BG check due to an excess in BOB.
For instance, for someone with:
Avg TDD 1.25%* of TDD
43 units units
This individual would be alerted whenever they give a bolus but have 0.54 u or more of BOB present.
* 1.25% of TDD provides a reasonable degree of safety but may need modification

43. Inadequate Manual Entry Of BGs10
Issue: Pump users often do not enter BG values into their pump if they must do it manually.

44. Inadequate Manual Entry Of BGs10
Issue: In the CDA study where BG values can be entered either manually or automatically, users entered only 2.6 BG values per day manually versus 4.1 values per day for pumps that had an attached glucose meter. This means that BOB may be taken into account for 1.5 additional boluses per day when BG readings are not automatically entered.

45. Standard For: Inadequate Manual Entry Of BGs10
Standard For: Inadequate Manual Entry Of BGs
Due to a significant decrease in glucose entry when BGs must be entered manually, and the benefit to control that this provides, we recommend that all pumps be enabled to have direct BG entry of BG test results from two or more meters.

46. Correction Bolus Excess11
Issue: Hyperglycemia is more common than hypoglycemia for most people on insulin pumps.
When glucose levels consistently run high, many pump users address the problem by giving frequent correction boluses rather than increasing their basal rates or carb boluses.
In these cases, the correction bolus % of the TDD can become excessive, but this information is either not shown in some pumps or no alert is given regarding the excess.

47. Standards For: Correction Bolus Excess11
Standards For: Correction Bolus Excess
We suggest that the pump wearer and clinician be alerted when the wearer uses more than 8% (adjustable) of their TDD for correction bolus doses for at least 4 days in a row (adjustable).
We recommend that, once an excess in correction bolus is identified, that the user be given instruction in how to safely distribute any excess into carb boluses or basal rates.

48. Excess Hypoglycemia 12
Issue: Current insulin pumps and glucose monitors do not warn users that they are experiencing hypoglycemia that is too severe or too frequent.
Although most insulin pumps contain adequate data to do so, they do not provide sufficient guidance for correcting this serious problem.

49. Standard For: Excess Hypoglycemia12
Standard For: Excess Hypoglycemia
We recommend that insulin pumps which store glucose and insulin dosing data alert users when they experience severe or excessive hypoglycemia and provide specific guidance regarding likely causes.

50. Excess Hyperglycemia 13
Issue: Current insulin pumps and glucose monitors do not warn users that they are experiencing hyperglycemia that is too severe or too frequent.
Although most insulin pumps contain adequate data to do so, they do not provide sufficient guidance for correcting this serious problem.

51. Standard For: Excess Hyperglycemia13
Standard For: Excess Hyperglycemia
We recommend that insulin pumps which store glucose and insulin dosing data alert users when they experience severe or excessive hyperglycemia and provide specific guidance regarding likely causes.

52. Duration Of Insulin Action14
Issue: Although DIA is designed to measure the glucose-lowering activity of a carb or correction bolus at any time, various clinicians recommend DIA times that vary from 2 to 6 hours or more, despite the fact that interindividual variation in pharmaco-dynamics time is generally less than 25%.
There are also questions about whether pharmaco-dynamic time from GIR studies is equivalent to DIA time?

53. Review How Long Do Boluses Lower The BG?14
Novolog claims 3 to 5 hours 10, but numerous studies show rapid insulin lowers the glucose for 5 hours or more.
With Novolog (aspart) at 0.2 u/kg (0.091 u/lb), 23% of glucose lowering activity remained after 4 hours.12
Another study found Novolog (0.2 u/kg) lowered the glucose for 5 hours and 43 min. +/- 1 hour.13
After 0.3 u/kg or u/lb of Humalog (lispro), peak glucose-lowering activity was seen at 2.4 hours and 30% of activity remained after 4 hours. 11
These times would be longer if the unmeasured basal suppression in pharmacodynamic studies were accounted for.
10 Novolog product labeling information, October 21, 2005.
11 From Table 1 in Humalog Mix50/50 product information, PA 6872AMP, Eli Lilly and Company, issued January 15, 2007.
12 Mudaliar S, et al: Insulin aspart (B28 Asp-insulin): a fast-acting analog of human insulin. Diabetes Care 1999; 22:
13 L Heinemann, et al: Time-action profile of the insulin analogue B28Asp. Diabetic Med 1996;13:

54. An Accurate DIA Can Prevent Lows14
Accurate DIA Time
Accurate BOB
Accurate Boluses Accurate HypoManager
Better Readings, Fewer Lows
Prevention
Prediction

55. Review Short DIAs Hide Bolus Insulin Activity14
Review Short DIAs Hide Bolus Insulin Activity
A short DIA time creates significant problems because it hides true BOB level and its glucose-lowering activity. This:
Leads to “unexplained” lows
Leads to incorrect adjustments in basal rates, carb factors, and correction factors
Causes user to start ignoring their “smart” pump’s advice
In contrast, an inappropriately long DIA overestimates bolus insulin activity. DIA should be selected, based on its real insulin action time.
Do NOT modify the DIA time to fix a control problem

56. Review Duration Of Insulin Action (DIA)14
Review Duration Of Insulin Action (DIA)
Accurate bolus estimates require an accurate DIA. DIA times shorter than 4 to 7 hrs will hide BOB and its glucose lowering activity
Glucose-lowering Activity
2 hrs
4 hrs
6 hrs

57. Apidra product handout, Rev. April 2004a
Review DIA 14
Regular
Large doses (0.3 u/kg = 15 u for 110 lb. person) of “rapid” insulin in 18 non-diabetic, obese people
Med. doses (0.2 u/kg = 10 u for 110 lb. person)
Apidra product handout, Rev. April 2004a

58. Review Does Dose Size Affect Duration Of Action?14
Review Does Dose Size Affect Duration Of Action?
This graphic suggests that smaller boluses do not lower the BG as long as larger boluses.
However, this may not be true – see next 2 slides.
For a 154 lb or 70 kg person:
0.05 u/kg = 3.5 u
0.1 u/kg = 7 u
0.2 u/kg = 14 u
0.3 u/kg = 21 u
Woodworth et al. Diabetes. 1993;42(Suppl. 1):54A

59. Review Pharmacodynamics Is Not DIA14
The DIA time entered into an insulin pump is based on studies of insulin pharmacodynamics.
However, the traditional method used to determine the pharmacodynamics of insulin action routinely underestimates insulin’s true duration of action. See next slide.

60. Review Pharmacodynamics Underestimates DIA And Overestimates Impact Of Bolus Size14
To measure pharmacodynamics, glucose clamp studies are done in healthy individuals (0.05 to 0.3 u/kg)
Injected insulin ALSO SUPPRESSES normal basal release from the pancreas (grey area in figure)
The basal suppression makes smaller boluses appear to have a shorter DIA

61. Review Pharmacodynamic Time Does Not Equal DIA14
After accounting for the lack of basal suppression,
True DIA times become longer than the pharmacodynamic times derived from typical research
At least some of the apparent variation in DIA due to relative bolus size disappears
Some of the apparent inter- individual variation in pharmacodynamics may also disappear

62. Standard For: Duration Of Insulin Action14
Standard For: Duration Of Insulin Action
We recommend that a panel of researchers and clinicians who are familiar with insulin pharmacodynamics recommend consistent and safe guidelines for DIA times in pumps for children and adults.
These guidelines will be used to advise clinicians, train pump users, and as a reference on the DIA setting screen in insulin pumps.

63. Linear Versus Curvilinear DIA15
Issue: The current straight-linear method of measuring DIA is less accurate than curvilinear method for estimation of residual BOB.
DIA times selected in pumps which use a linear method must be shorter to approximate the DIA in a pump that uses a curvilinear method.
Pump manufacturers currently use at least 3 different methods to measure glucose-lowering activity

64. Linear And Curvilinear DIA Compared15
Linear And Curvilinear DIA Compared
Set
5 hr Linear
5 hr Curvilinear
From Pumping Insulin, 4th ed., adapted fom Mudaliar et al: Diabetes Care, 22: 1501, 1999

65. The Modified Triple-Linear DIA15
An alternative and more accurate approach would be to modify the linear method into a triple-linear method to provide more precise BOB estimates.

66. Example Triple-Linear DIA Times15
Example Triple-Linear DIA Times
A triple linear line can more closely imitate a curvilinear DIA.
For a 5 hr DIA:
30 min – no change
3 hrs – fall 75%
1.5 hrs – fall last 25% (approximate values)
5 hr Triple Linear
From Pumping Insulin, 4th ed., adapted fom Mudaliar et al: Diabetes Care, 22: 1501, 1999

67. Standard For: Linear Versus Curvilinear DIA15
Standard For: Linear Versus Curvilinear DIA
We recommend that insulin pumps use either a 100% curvilinear or a triple-linear method to improve the accuracy of BOB estimates.

68. Infusion Sets 16
Issue: Infusion set design issues and inadequate site preparation training introduce erratic losses of control for a significant number of pump wearers.

69. Review Infusion Set Failure16
Loss of glucose control caused by infusion set failure can occur due unrecognized pullout of the set.
A more common error occurs when Teflon infusion sets come loose and some insulin leaks back to the skin surface. This causes unexplained high readings rather than the complete loss of control typically seen with a complete pullout.
Metal needle sets can also cause occasional bleeding under the skin that interferes with insulin delivery and leads to elevated glucose readings.
Selecting the right infusion set plus good site technique can significantly reduce this unnecessary loss of control.

70. Review Causes For Infusion Sets Failure16
Review Causes For Infusion Sets Failure
Certain infusion sets are more prone to failure due to their design.
Other sets fail when tugging and pulling on an unanchored infusion line during routine wear loosens the Teflon beneath the skin.
In a review of dozens of pictures of infusion sets online and insulin pump manuals, anchoring of the infusion line is usually not recommended and is not generally done. Anchoring of the infusion line can:
Stop movement of Teflon catheter under the skin
Stop “unexplained highs” caused when insulin leaks back to surface
Reduce skin irritation
Prevent many pull outs
Example

71. Review Detection Of Bad Infusion Set Or Site16
If a pump user has “unexplained” highs, ask:
How often do unexplained highs happen?
Do they usually correct when you replace your infusion set?
For “yes” answers:
Always use tape to anchor the infusion line
Consider changing to a different infusion set
The right infusion set and good site technique prevents headaches and improves the A1c

72. Tool Infusion Set Monitor16
Insulin pumps with direct BG entry can identify those who may be having consistent but intermittent loss of glucose control secondary to infusion set failure. The pump can:
Show avgerage time and interval variation between use of reservoir loads or the prime function in the pump.
Show average BGs for each 12 hour segment following set changes (indicated by the prime function) over at least the last 7 set changes (or as soon as statistical significance is reached).

73. Need For An Infusion Set Monitor16
Many pump wearers have random erratic readings that are greatly reduced in number when they change to a different infusion set or start to anchor their infusion lines with tape to stop line tugging.
However, there is currently no tool for clincians or pump users to tell who is having problems with their infusion sets.

74. Standards For: Infusion Sets16
Standards For: Infusion Sets
We recommend that infusion sets be expected to perform at least 72 hours without a loss of glucose control.
We recommend that monitoring be provided in all insulin pumps to detect consistent patterns of infusion set problems or failure for individual pump users.

75. Standards For: Infusion Sets16
Standards For: Infusion Sets
3. We recommend that insulin pump manuals and training cover methods to identify and prevent infusion set failure.
4. We recommend that future infusion set designs incorporate easy to use methods to anchor infusion lines and minimize tugging of the infusion line near the infusion site.