INSULIN INSIGHTS

Precision Insulin Management with Smart* Insulin Pens 

InPen and Guardian Sensor

Precision insulin management, defined as delivering the correct dose1, is a lesser-studied factor that contributes toward better glycemic management.

An international comparison study in people with T1D reported a median A1C range of 7.4%-9.4% across countries and age groups, exceeding target A1C recommendations2. Adolescents and young adults are particularly challenged in reaching glycemic targets as highlighted in the T1D Exchange Registry data showing ~81% of individuals aged 13- 25 years failed to meet A1C targets3, 4. This data underscores the need for timely insulin regimen intensification. Individualized insulin therapy settings that are fine-tuned on an ongoing basis are critical for smart insulin delivery systems whether pump or pen to be effective and are important factors in precision insulin management. Here the discussion is broadened to discuss additional factors critical to the larger topic of precision insulin management, of particular importance to the pediatric type 1 diabetes (T1D) population.     

A data-driven approach to insulin therapy will be critical to any discussion of precision insulin management. The three hallmarks of a data-driven practice model for intensive insulin therapy include5:

  • Identify: Help individuals make an informed decision regarding the best method of insulin delivery for their circumstances and preferences
  • Configure: Individualize insulin therapy settings, schedule, dose, and glucose check reminders; sync to available glucose monitors to integrate related data
  • Collaborate: Use the data in a timely, ongoing basis in partnership with the person with diabetes to intensify and fine-tune the insulin regimen.
The American Diabetes Association Standards of Medical Care in Diabetes 2021 opened the Technology in Diabetes chapter noting, “there is no one-size-fits-all approach to technology use in people with diabetes” 7.

ADA Recommendations Regarding Insulin Delivery7
7.16 Base decision on: Patient preference, insulin type, dosing regimen, cost and self-management capabilities. B
7.17 Insulin pens or injection aids may be considered for patients with dexterity issues or vision impairment to facilitate accurate insulin dosing. C
7.18 Smart pens may be useful for some patients to help with dose capture and dosing recommendations. E
7.19 FDA approved insulin dose calculators/decision support systems may be helpful for titrating insulin doses. E

The standards further note, in reference to smart insulin delivery devices, “provider input and education can be helpful for setting the initial dosing calculations with ongoing follow-up for adjustments as needed” 7. Inputting the correct, individualized settings in the smart insulin pen is critical for precise insulin management.  It is also important to assess and optimize basal insulin prior to fine-tuning the insulin therapy settings.

It will be necessary to refine these insulin therapy settings over time as life and diabetes evolve; pediatric patients grow, activity, schedules, and living situations change and weight is gained (or lost).  Integrated data reports from smart insulin pens enable the use of data to optimize the insulin regimen and fine-tune therapy settings.  These data reports are available remotely enabling remote patient monitoring and virtual care facilitating more timely therapy adjustments.  Insulin pens have consistently outperformed syringes as delivery devices due to their greater accuracy and precision of dosing, ease-of-use, and patient preference. These advantages make them better suited to administer insulin in hypoglycemia-prone insulin-sensitive people with T1D, particularly younger children1.;

Aanstoot et al, emphasize the importance of 0.5 unit dosing capability, particularly for people who need very small dosages1. With standard insulin pens, individuals must round their dose to the nearest whole unit, thereby administering more or less insulin than required. Half-unit insulin pens offer finer insulin dosing which may help improve overall glycemia and potentially prevent hypoglycemia. Patients using insulin-to-carbohydrate ratios to determine insulin dosing may especially benefit from half-unit insulin delivery. Currently, five half-unit insulin pens are commercially available in the United States: HumaPen Luxura® HD, NovoPen Echo®, JuniorSTAR®, Humalog® Junior Kwikpen, and InPenTM smart insulin pen. All pens except the JuniorSTAR® have demonstrated accuracy at 0.5U of insulin1.

Priming before each insulin dose is an important part of precision dosing. Priming removes air from the needle and cartridge that may collect during normal use ensuring the full dose is delivered. It is important that pen users prime before every injection. A stage 4 smart insulin pen must be able to differentiate prime from therapy doses6. This is necessary in order to accurately track active insulin or insulin on board.  In order to safely correct between mealtime doses, it is essential that active insulin be accurately tracked. InPenTM smart insulin pen, the first FDA-cleared, Stage 4 Smart Insulin Pen, is able to do this based on a proprietary algorithm.  Additionally, users are able to indicate if a dose labeled prime is actually a therapeutic dose or vice versa.

Don’t forget the basics:  Injection technique, site rotation, insulin quality.

It is important to not assume an individual who has had diabetes for years knows how to inject correctly. Ask individuals to periodically demonstrate how they inject so that problems with the injection technique may be uncovered and corrected. Even in a virtual visit, the camera can be used to demonstrate the correct insulin injection technique.

Also important is proper site rotation. Per ADA standards, “examination of insulin injection sites for the presence of lipohypertrophy as well as an assessment of injection device use and injection technique, are key components of a comprehensive diabetes medical evaluation and treatment plan” 7. Research indicates that ~65% of individuals using insulin have lipohypertrophy8. Clinicians should also be sure to discuss how individuals are storing their extra insulin cartridges, pens, and basal insulin and ensure individuals or keeping track of insulin expiration dates. With InPen™ smart insulin pen, once a cartridge is inserted, the smart insulin pen will detect and alert the user when the cartridge has exceeded 28 days. It will also alert if the pen and cartridge have been exposed to unsafe temperatures.

To be successful in their glucose regulation, many people on intensive insulin therapy use carbohydrate counting to measure the carbohydrate content of the meal and calculate the exact insulin dose needed to maintain optimal postprandial glycemia. The insulin-to-carbohydrate ratio and correction factor for hyperglycemia are both individualized to one’s insulin sensitivity. These ratios may vary throughout the day, depending on meal timing and other factors, and is frequently more variable in pediatric populations due to their erratic eating habits, physical activity, and changing metabolism throughout development. Matching carbohydrate intake and the insulin requirement requires both accurate and precise delivery of insulin to address metabolic needs, minimize glycemic variability, and optimize glycemia. Smart Insulin Pens facilitate calculation and delivery of more exact bolus doses for meals and corrections. In addition to dosing accurately, bolus insulin injection must be timed appropriately before the meal to avoid post meal glucose spikes9.

Conclusion: Precision Insulin Management Matters

We have discussed important considerations for precision insulin management:

  • Determining the best method of insulin delivery for the individual
  • Calculating and fine-tuning precise insulin therapy settings (based on integrated data reports)
  • Precise dose delivery with insulin pens offering half-unit dose increments
  • Priming and prime and therapeutic dose differentiation
  • Assuring correct insulin injection technique, rotation of sites and storage of insulin
  • Accurate, customized dose calculators for both meal and correction doses with objective active insulin tracking

Insulin pens have shown a positive impact on the health-related quality of life with less frequent and less severe episodes of hypoglycemia1. Outcomes such as treatment satisfaction, ease-of-use, discreetness, convenience and flexibility, injection pain, and patient preference all favor the use of insulin pens1. Insulin pens with 0.5 unit dose accuracy are critical for those who need stringent glycemic control, as they deliver more accurate and precise doses. Half-unit insulin pens are also evolving with technological advances such as the stage 4 smart insulin pen, InPenTM smart insulin pen linked by Bluetooth® to a smart phone application that automatically records doses and incorporates a dose calculator and optional dose reminders to support precise insulin management.

Here’s to precise insulin management with Smart Insulin Pens!

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Smart insulin pens connect to a mobile app to provide dosing calculations, reminders and CGM system integration.

1

Aanstoot HJ, Rodriguez H, Weinzimer S, Vint N, Koeneman L. Precision Dosing of Rapid-Acting Insulin Matters. Diab Technol Ther. 2020;22(5):1-6.

2

McKnight JA, Wild SH, Lamb MJ, et al.: Glycaemic Control of Type 1 Diabetes In Clinical Practice Early In the 21st Century: An International Comparison. Diabet Med. 2015;32:1036–1050.

3

Miller KM, Foster NC, Beck RW, et al.: Current State Of Type 1 Diabetes Treatment In The U.S.: Updated Data From the T1D Exchange Clinic Registry. Diabetes Care. 2015;38:971– 978.

4

Beck RW, Miller KM, Foster NC: The T1D Exchange Clinic Network and Registry: 10 Years of Enlightenment On the State Of Type 1 Diabetes In the United States. Diab Technol Ther. 2019;21:310–312.

5

MacLeod J. Presenting the Case for Smart Insulin Pens. ADCES In Practice. 2020; 8(4):48-52.

6

Kerr D, Warshaw H, Choi NY. Smart Insulin Pens Will Address Unmet Needs for People with Diabetes Using Insulin. Endocrine Today. 2019; (May);20-21.

7

American Diabetes Association Diabetes Technology:  Standards of Medical Care in Diabetes –2021. Diabetes Care. 202144(S1):S85-S99.

8

Frid AH, Kreugl G, Grassi G, Halmi S. et al. New Insulin Delivery Recommendations. Mayo Clin Proc. 2016;91(9):1231-1255.

9

Slattery, D, /Amiel SA, Choudhary P. Optimal Prandial Timing of Bolus Insulin in Diabetes Management, a Review. Diabet Med. 2018;35:306-316.