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. 2021 Oct 4;68(3):180–187. doi: 10.2344/anpr-68-03-16

Review of Modern Insulin Pumps and the Perioperative Management of the Type 1 Diabetic Patient for Ambulatory Dental Surgery

Philip M Yen *,✉, Andrew S Young †
PMCID: PMC8500319  PMID: 34606570

Abstract

The use of continuous insulin pump systems for effective management of glycemic control in the patient with type 1 diabetes mellitus (T1DM) is steadily increasing. Although the types of devices and their respective manufacturers vary, insulin pumps all utilize similar underlying concepts based on the delivery of exogenous insulin to patients with T1DM in manners that more closely approximate the normal biologic function and performance of the pancreas. As insulin pumps becomes more commonplace and their use more widespread, the sedation or anesthesia provider must ensure familiarity with the basic knowledge of pump function and the various perioperative management considerations. This review provides a concise overview of the pathophysiology of T1DM, introduces foundational aspects of common insulin pump systems, and discusses several general recommendations regarding the perioperative management of insulin pumps during dental surgeries.

Keywords: Insulin pump, Continuous insulin infusion, Type 1 diabetes, Continuous glucose monitor, Basal infusion rate, Pump therapy

Type 1 diabetes mellitus (T1DM) is an autoimmune disease resulting in the destruction of insulin-producing β cells within the pancreas. The complete lack or inadequate production of insulin found with T1DM differs from type 2 diabetes mellitus (T2DM), which typically involves a relative insufficiency of insulin in conjunction with varying degrees of insulin resistance. Although blood glucose levels must be extrinsically regulated in both types of diabetes, T1DM requires administration of exogenous insulin. Traditionally, exogenous insulin administration involves subcutaneous injection with hypodermic needles in combination with either conventional medical syringes or pen-like devices. However, modern advances in insulin therapy now include the use of a continuous pump to facilitate improved long-term glycemic control and reduce the risk of ketoacidosis and other diabetic microvascular and macrovascular complications.1

REVIEW OF TYPE 1 DIABETES MELLITUS

Epidemiology, Pathophysiology, and Diagnosis

Although only representing 5% to 10% of all people with diabetes mellitus, T1DM has seen a steady increase in overall incidence and prevalence. The United States has the highest incidence of T1DM in the world. Furthermore, the 2020 National Diabetes Statistics Report estimates there are currently 1.5 million Americans diagnosed with T1DM.2,3

In T1DM, autoimmune destruction of the β cells within the islets of Langerhans scattered throughout the pancreas cause an absolute deficiency of insulin production. Insulin participates in a host of vital homeostatic functions including glycogen, fat, and protein synthesis. Additionally, insulin promotes glucose uptake by facilitating the transport of glucose, the primary substrate for cellular metabolism, across the cellular membrane.4

Diagnosis of T1DM varies between children and adults. Children with T1DM typically present with symptoms of hyperglycemia, the onset of which can be rather sudden and can escalate to a medical emergency in situations involving a delay in diagnosis or treatment.5 Pediatric patients commonly present with polydipsia, polyuria, and polyphagia secondary to osmotic diuresis. This can progress to include significant electrolyte abnormalities and even diabetic ketoacidosis (DKA) requiring hospitalization and treatment with IV fluids, insulin, potassium replacement, and close cardiac monitoring via an ECG.

For adults, T1DM diagnosis is made based on plasma glucose or glycated hemoglobin (HbA1c) criteria. Diabetic patients present with random and repeated blood glucose levels ≥ 200 mg/dL, fasting blood glucose levels ≥ 126 mg/dL, or an HbA1c ≥ 6.5% with classic symptoms of diabetes.3 Currently, it is estimated that less than one-third of individuals living with T1DM are consistently maintaining target blood glucose levels within the range of 70 to 180 mg/dL.6

Treatment and Management

Insulin requirements vary across specific patient populations, but all patients with T1DM have an absolute insulin deficiency that requires administration of exogenous insulin. Preferred treatment consists of multiple daily injections (MDI) utilizing a basal (metabolic baseline level) dosing regimen or, alternatively, a continuous subcutaneous insulin infusion (CSII) utilizing an insulin pump.7

Multiple types of insulin, from rapid-acting to long-acting, can be used in the management of T1DM. In the case of MDI, the patient will typically use rapid-acting insulin with each meal along with long-acting basal insulin for hyperglycemic control. In CSII, only rapid-acting insulin is administered via indwelling subcutaneous catheterization. Dosing is modified based on patient-specific factors including diet, physical activity, and self-monitoring or continuous glucose monitoring (CGM) results.

Generally, insulin dosing is a factor of the total carbohydrates consumed during mealtime and the insulin-to-carbohydrate ratio (ICR). ICR is individualized and dependent on how many grams of carbohydrates is covered by a single unit of insulin based on carbohydrate consumption, the patient's current blood glucose level, and anticipated physical activity. The ICR is not constant and tends to be higher in the morning and evenings. One common approach to determine the ICR is the “500 rule,” based on the assumption that the average person consumes ∼500 grams of carbohydrates each day. The ICR can be approximated by dividing 500 by the patient's total daily insulin dose (TDD; basal insulin + mealtime insulin).8

An additional tool in the calculation of insulin dosing is determining the patient's insulin sensitivity factor, which helps estimate the reduction in blood glucose produced by 1 unit of either rapid-acting or regular insulin. To calculate the insulin sensitivity factor for patients taking rapid-acting insulin, 1800 is divided by their TDD of rapid-acting insulin, whereas for patients taking regular insulin, 1500 is divided by their TDD of regular insulin. In either case, this can be used to determine a patient's correction factor or how many mg/dL a patient's blood glucose level should decrease following the administration of a single unit of insulin.8

Ideally, blood glucose readings are repeatedly sampled throughout the day with patients checking their blood glucose in the morning, before and after each meal, before bedtime, and during suspected episodes of hypoglycemia. CGM involves transcutaneous sensors implanted in the patient's subcutaneous tissues that measure interstitial glucose levels and then transmit that data to a receiver for real-time display. This revolutionary technology has quickly grown to become a useful tool in management of T1DM.9

Although technology such as CGM and automated insulin delivery systems or pumps have improved glucose control and prevention of hypoglycemia, physiologic demand for glucose can vary by individual throughout the day and therefore requires an individualized approach.9 These clinical needs have driven further development of insulin pump therapy.

INSULIN PUMPS

First introduced in the late 1970s, insulin pump therapy largely revolves around 2 key operating principles: 1) continuous delivery of background or “basal” insulin (ie, the amount necessary for maintenance during fasting), and 2) additional administration of meal-related or “bolus” insulin.1,9,10 The external pump is worn continuously by the patient and delivers insulin through a cannula inserted just beneath the surface of the skin. The delivery system or pump is programmed and managed cooperatively by the patient and their health care team in order to optimize insulin dosing, improve long-term outcomes, and reduce the progression of complications associated with diabetes, such as retinopathy, neuropathy, and nephropathy.

Advantages of Insulin Pumps

Compared with MDI, CSII has consistently shown to produce improved glycemic control, lowered HbA1c levels, and decreased risk of hypoglycemic episodes.10,11 Consistent glycemic control directly affects macrovascular complications like cardiovascular mortality and morbidity, exhibiting favorable long-term outcomes tied to the reduction of coronary artery disease and a decreased incidence of DKA-related hospitalizations. Interestingly, the most commonly perceived advantage to CSII was lifestyle flexibility leading to an improvement in depression, anxiety, responsibility, self-esteem, and family functioning.11,12

Programmable insulin delivery allows a closer match of exogenous insulin administration to the patient's physiologic needs, because the basal-bolus delivery scheme is more representative of normal pancreatic function. CSII devices only use short- or rapid-acting insulin, minimizing peaks and absorption-related variability. Essentially, the CSII continual basal rate acts as a very long-acting insulin. The development of intermediate- and long-acting insulins was partly fueled by the lifestyle demands of patients with T1DM to reduce the number of injections. The extended duration of action of long-acting insulin formulations is made possible by utilizing slow-release carriers or molecules that have short-acting insulin attached or integrated. CSII devices obviate the need for such formulations by simply providing short-acting insulin via a continuous infusion. CSII devices utilize 1 injection site for up to 72 hours, thus reducing variations in systemic absorption and minimizing the number of injections. However, local tissue reactions such as infusion site lipomas or infections can occur, necessitating the sites to be moved every 72 hours.22 Several marquee studies showed a reduction in glycemic variability and improved glycemic control, which are the ultimate goals of insulin therapy for the patient with T1DM.25 Decreased risk of severe hypoglycemia and need for emergent medical attention are additional byproducts of the improvement in glycemic control. General decreases in the need for hospitalization and cost of care have also observed. Finally, most studies show that users report improved quality of life and treatment satisfaction with the CSII systems.14,18

Although the majority of patients using CSII devices are patients with T1DM, a larger percentage of the insulin-dependent T2DM population is beginning to also utilize these devices. The aforementioned advantages of improved glycemic control and more optimized HbA1c levels are also applicable to the T2DM population. As of 2018, an estimated 30% to 40% of patients with T1DM utilize a CSII system, up from 20% to 25% in 2010. The data for T2DM are less robust, but estimates of CSII pump usage in this population are between 5% and 8%.20,21 Increasing usage is anticipated as insulin pump technology continues to improves.19

Additional Information

An insulin pump delivers continuous insulin via a subcutaneous site to provide a steady basal rate. An additional bolus of insulin can be programmed and delivered by the user during mealtimes or periods of hyperglycemia. The basal insulin rate is highly specific to the patient's individual physiologic needs and often multiple basal rates (ie, alternate or temporary basal rates) are used over a 24-hour period. This can help account for physiologic variations in insulin demand over episodes of increased exercise or periods of fasting concomitant with work or sleep schedules. These programmable changes can have perioperative implications because an optimal basal rate for surgery can be easily selected. Bolus infusions are also tailored to individual patient's needs and are optimal when the user can provide accurate information regarding mealtime carbohydrate content.14 Patients who are on pump therapy, much like those on MDI therapy, will require continual refinement and adjustments to their basal rates, insulin sensitivity factors, and insulin to carbohydrate ratios throughout the lifetime of the insulin pump. Patients will ideally have these types of parameters assessed and adjusted every 3 to 6 months.

There are 2 main types of pumps. The first type has 3 components: a skin patch with the subcutaneous injection site, tubing to connect the pump and the skin patch, and a small handheld or wearable device containing the pump and its controls (Figure 1). The second type is referred to as a tubeless system, and these pumps have just 2 components: the skin patch with the subcutaneous injection site that houses the insulin and the pump, and a wirelessly connected handheld control unit (Figure 2).

Figure 1.

Figure 1.

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Insulin pump with tubing and cannula. Handheld or wearable insulin pump with controls and insulin reservoir connected to the transcutaneous injection site (cannula) via tubing.

Figure 2.

Figure 2.

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Tubeless insulin pod and remote control. Insulin pump with built-in reservoir and transcutaneous injection site (cannula). Self-contained pump is controlled wirelessly with a remote control or mobile device (cell phone).

The basal rate of insulin delivery provides ∼50% of the patient's total daily insulin requirement, but this value can fluctuate, especially in pediatric patients. The ideal target level of basal insulin infusion is a rate low enough to prevent hypoglycemia, yet high enough to be sufficiently therapeutic and improve glycemic control. The therapeutic goal is to establish an optimal level of insulin delivery in order to maintain normoglycemia and prevent ketosis even in the fasted state but utilize a sufficiently low concentration so as to not override the hepatic gluconeogenesis system that normally functions to deliver physiologic glucose needs for the vital organ systems “on demand.”13,19

Integration With Glucose Monitoring Devices

Modern pump systems are classified by the US Food and Drug Administration into 2 major categories, Class II (moderate risk) and Class III (higher risk) devices. A Class II device contains only an insulin pump, whereas a Class III device contains a CGM system integrated with an insulin pump. This integration illustrates the trend toward developing a fully closed-loop system or “artificial pancreas.” Reliance on this type of independent glucose sensing and insulin delivery system necessitates strong safety parameters. Technology in this area continues to evolve, and the hope is that a fully independent artificial pancreas system can be shown to be safe and effective.

Current technology that integrates a CGM system along with a pump offers additional advantages to the user including better fail-safe systems to prevent hypoglycemia and conversely, better immediate response systems that adjust the basal rate, increasing insulin delivery whenever hyperglycemia is sensed.16 The most recent devices now have a “threshold suspend” system where the basal rate of insulin is stopped for a period of time if a low glucose level is detected and the patient fails to respond to the hypoglycemia alarm.15

The CGM system may be a separate unit from the insulin pump system and utilize a wireless connection. Alternatively, some CGM systems and insulin pumps are fully integrated into a single unit.

Adverse Events

Insulin pump failures can lead to adverse events (AEs) related to either hyperglycemia or hypoglycemia and can be attributed to mechanical failures, blockages within the infusion set, infusion site complications, instability of the insulin stored within the pump, and user error.15 It is difficult to know the true incidence of AEs related to pump usage because data reporting is often submitted directly to pump manufacturers. There are a very limited number of studies, and there is no mandatory reporting system currently in place for AEs related to pump systems. A study from New Zealand estimated that a patient utilizing a pump system will experience ∼3.4 minor AEs per year. Between 2% and 10% of patients reported a severe AE, such as hyperglycemia or DKA that resulted in hospitalization.23,24 Pump malfunctions or failure rates are reported to be 68% in some studies, although these rates have been declining rapidly over the last 10 to 15 years likely due to technological improvements.24 A joint statement from European and American diabetes research groups attributed the majority of AEs to user error, and their concluding recommendations focused on improved patient education and support systems to further reduce the frequency of AEs.15 Nonetheless, improvements in insulin pump technology and mechanical function remain an important component of safety and efficacy.

PERIOPERATIVE MANAGEMENT OF INSULIN PUMPS

Managing an insulin pump perioperatively is largely dependent on the specific manufacturer and type of pump being utilized. However, there are several guiding principles that can be helpful in obtaining an optimal outcome for patients using insulin pump therapy.

It is advisable to develop a clear management plan with the patient that includes how the pump will be managed intraoperatively, especially in the event of hypoglycemia or hyperglycemia. A signed consent from the patient/guardian to continue pump use throughout the perioperative period is recommended.

Because infusion catheters are changed every 3 days, the sedation or anesthesia provider should verify the last time the site was moved. Ideally the pump should be positioned in a new site at least 24 hours prior to surgery to minimize problems, such as cannula occlusion or erratic absorption, and to allow time to verify correct functioning of the pump and any accompanying CGM system if present.

As there is no universal management strategy for selecting or adjusting the basal infusion rate intraoperatively, consultation with the health care team managing the patient's diabetes (ie, their endocrinologist or primary care physician) can be helpful. The anesthesia provider generally has 2 options for managing the basal rate of insulin delivery: 1) maintain the normal basal infusion rate; or 2) reduce the basal rate, commonly down to 80%. Some pump systems will have an exercise rate, which is a reduced infusion rate to account for higher glucose demands during periods of increased physical exertion; this option can be selected as well. A lower infusion rate can alleviate the potential for perioperative hypoglycemia. It is helpful to remember that most patients on insulin pumps have basal rates that are slightly supraphysiologic because the goal of insulin therapy is to drive down their average blood glucose. This is advantageous for the long-term control of their T1DM but may pose a potential problem (eg, hypoglycemia) in the short-term intraoperative period. Nonetheless, the most clinically significant perioperative issue of hypoglycemia can be managed with exogenous dextrose even without making changes to the continuous pump system's basal rate. Also consider that during surgery the body is in a relative state of insulin deficiency as illustrated by commonly observed intraoperative hyperglycemia. Therefore, simply maintaining the patient's normal basal rate intraoperatively is often the preferred option.13,14

Bolus insulin should be stopped in anticipation of preoperative nil per os instructions. As with traditional scheduling considerations for the diabetic patient, patients with T1DM on pump therapy should be ideally scheduled for early morning appointments to minimize potential for hypoglycemia or hyperglycemia.

In addition to the standard line of preoperative questions relative to diabetes mellitus (eg, insulin sensitivity factor, most recent HbA1c, etc), the sedation or anesthesia provider should ask for a demonstration of how to use the insulin pump and the CGM, if present, with regards to the key controls listed in the Table.

Table.

Key Functional Controls of Insulin Pumps to Understand

1. How to check the blood glucose using the CGM?
2. How to check normal functioning of the pump's basal infusion?
3. How to manually stop or turn off the pump?
4. Is there a sensor augmented function that will deliver insulin at a set blood glucose?
5. Is there a threshold suspend mechanism that will stop the pump at a set blood glucose?
6. How to manually deliver a bolus of insulin if required?
7. What types of alarms are on the pump or CGM?
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Generally, the stepwise preoperative instructions that the sedation or anesthesia provider should consider are as follows: instruct the patient to continue their basal rates and withhold any boluses; have the patient check their blood glucose upon awakening in the morning, and if their blood glucose is lower than desired, have the patient consume a clear sugary liquid (eg, apple juice or Sprite) and notify the provider; and finally, verify the patient's blood glucose again preoperatively. The patient's blood glucose should be assessed at regular intervals throughout the intraoperative period as well as immediately prior to discharge. These recommendations allow the provider and the patient the opportunity to check for and correct any hypoglycemic events prior to and during surgery.13,18

During urgent or emergent surgeries, insulin pumps are commonly turned off. During elective surgery, maintenance of basal infusion rates is typically preferred because this usually leads to more stable intraoperative glycemic control. However, intraoperative hypoglycemia can occur, so the sedation or anesthesia provider should have dextrose on hand for immediate correction. In this regard, it is also be helpful to understand preoperatively how to manually suspend the pump's basal infusion rate. Each device has a unique user interface and controls, but the patient or caretaker should be able to demonstrate how to turn off or pause the basal infusion. It is important to note that the slow absorption of insulin from the infusion site will cause the effects of the basal infusion to persist for up to 2 hours after stopping the infusion. In most practical scenarios, leaving the basal rate unchanged during any hypoglycemic episodes and simply correcting the patient's blood glucose with IV dextrose is advisable.13 If hyperglycemia is encountered, previous interrogation of the insulin pump mechanics will allow for bolus delivery that should be dosed based on known insulin sensitivity factors. Temporary hyperglycemia is generally better tolerated then hypoglycemia, so aggressive lowering of the patient's blood glucose should be avoided.

Customary intraoperative glucose management techniques for the diabetic patient should be employed throughout the perioperative period. If a CGM device is not used, regular pre-, intra-, and postoperative glucose checks should be performed. IV solutions should be selected based on anticipated needs specific to the patient and the planned surgical procedure. The benefit of administrating a steroid (eg, dexamethasone) should be carefully weighed against the expected increase in blood glucose. In 1 study of healthy patients, a single 10-mg IV dose of dexamethasone increased the blood glucose (mean ± SD) from 97 ± 15 mg/dL to 149 ± 23 mg/dL over the course of 4 hours. The control group demonstrated a significantly reduced change from 88 ± 11 mg/dL to 103 ± 12 mg/dL.26

The use of electrocautery and insulin pumps is a potential concern that would ideally involve interrogation with the device's manufacturer. The primary concern with the pump involves possible electromagnetic interference that would cause damage or subsequent pump failure, although this occurrence has not been documented.13 Localized burns or superficial damage to the skin is not of significant concern. Pumps have been used safely concurrently with surgical electrocautery, but it is prudent to place the pump as far away from the site of electrocautery as possible.13,17 Generally, there are few instances in which turning off or adjusting the insulin infusion pump is necessary or practically useful.

POSTOPERATIVE MANAGEMENT

In the immediate postoperative period, the patient may not be ready to resume proficient management of their insulin pump. As such, it is advisable to have a knowledgeable caretaker assist in managing the patient and their pump. Either the patient or their caregiver may be instructed to resume the use of insulin boluses to correct for any increases in blood glucose levels as indicated. Patients should be reminded that postoperative pain may influence the desire to eat or drink, but special attention should be made to ensure that hypoglycemia is avoided. Frequent blood glucose checks are recommended until the patient is able to eat and drink comfortably and effectively manage their blood glucose normally. Patients are usually familiar with “sick day” protocols that can be used to monitor and correct for any unanticipated extremes in blood glucose levels due to transient increases in stress and/or decreases in appetite that may occur with acute illness. These protocols include more frequent monitoring for significant changes in blood glucose and potentially the presence of blood or urinary ketones secondary to hyperglycemia. During the perioperative period, these unanticipated events can be due to surgical stress or pump failure. Patients should be instructed to check their blood glucose more often than usual in order to detect any issues early. Blood glucose checks every 1 to 2 hours are ideal for the first few hours after surgery, and heightened vigilance may be recommended up to 48 hours postoperatively.13

CONCLUSION

Considering the ever-increasing incidence of diabetes mellitus and the expanding utilization of insulin pump therapy as a viable treatment modality across both T1DM and T2DM, knowledge of and familiarity with the fundamentals of CSII therapy is increasingly important for health care professionals. Providers of sedation and anesthesia for dentistry should be especially competent in the management of patients with T1DM throughout the entire perioperative period.

CONTINUING EDUCATION QUESTIONS

This continuing education (CE) program is designed for dentists who desire to advance their understanding of pain and anxiety control in clinical practice. After reading the designated article, the participant should be able to evaluate and utilize the information appropriately in providing patient care.

The American Dental Society of Anesthesiology (ADSA) is accredited by the American Dental Association and Academy of General Dentistry to sponsor CE for dentists and will award CE credit for each article completed. You must answer 3 of the 4 questions correctly to receive credit.

Submit your answers online at www.adsahome.org. Click on “On Demand CE.”

CE questions must be completed within 3 months and prior to the next issue.

  1. Insulin produced by β cells within the pancreas are responsible for all the following functions EXCEPT:

    1. fat production.

    2. gluconeogenesis.

    3. protein synthesis.

    4. transmembrane glucose transport into cells.

  2. Infusion pumps utilize only long-acting basal insulin for the management of type 1 diabetes mellitus.

    1. True

    2. False

  3. Advantages of continuous insulin pumps include which of the following?

    1. They can be worn only when needed.

    2. They decrease the risk of hypoglycemic episodes.

    3. They have virtually no risk of pump malfunctions or failures.

    4. They reduce the risk of injection site infections compared with multiple daily injections of insulin.

  4. Which of the following considerations should be addressed for patients with insulin pumps undergoing dental surgery?

    1. Consider programming a reduced infusion rate prior to surgery.

    2. Informed consent should include specifics for intraoperative pump management.

    3. Verify new injection site relocation at least 24 hours prior to planned surgery.

    4. All of the above

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