Insulin Pump Use in Adults with Type 1 Diabetes

Abstract

In recent years continuous subcutaneous insulin infusion pumps have become widely adopted in many parts of the world in the treatment of type 1 diabetes in adults. A comprehensive summary of all aspects of pump therapy is beyond the scope of this article, and in this review we will focus on several practical issues that in our experience are of clinical importance in the care of patients using insulin pumps. These include: benefits and risks of pump therapy, including the use of pumps to limit hypoglycemia; individual patient considerations in choosing between pump therapy and multiple daily injections; common pump-specific etiologies of erratic glucose control, including routine clinical practices that can assist with the detection of these problems; and the use of different pump bolus types for prandial insulin coverage.

Benefits and Risks of Pump Therapy

I n the past few years there have been several meta-analyses comparing insulin pumps and multiple daily injections (MDI) as tools for intensifying glycemic control.^1
–3 These analyses of the randomized controlled trials in the published literature indicate that adult patients with type 1 diabetes using continuous subcutaneous insulin infusion (CSII) have a 0.4–0.5% lower hemoglobin A1c (HbA1c) than MDI therapy, without an increase in hypoglycemia and with lower insulin requirements.² The improvements with pump therapy appear to be greater in individuals who have poorer glycemic control.⁴ These earlier meta-analyses included MDI regimens using NPH or ultralente, but even the more recent randomized controlled trials using the newer long-acting insulin analogs still suggest CSII is superior to MDI.^5,6 Complications related to pump therapy, such as ketoacidosis, pump malfunction, and infusion site problems, are often not reported in the trials, and most of the evidence suggesting that CSII is associated with an increased risk for ketoacidosis date from the 1980s.^7
–9 Patient education about infusion site care and troubleshooting for “unexplained” hyperglycemia have both been critical in decreasing the risk for ketoacidosis.¹⁰

Hypoglycemia and Pump Therapy

Pump therapy permits patients tightly titrate the insulin delivery based on time of day, level of activity, and food intake and can be an effective tool in reducing glycemic variability.⁴ Several national and international clinical guidelines^11
–13 recommend CSII as a therapeutic option for people with type 1 diabetes with problematic severe hypoglycemia or unsatisfactory glycemic control with MDI. However, there have been conflicting results from different meta-analyses^2,14,15 regarding the reduction in hypoglycemia with pump therapy. The meta-analysis conducted by Pickup and Sutton¹⁴—which was restricted to studies published since 1995 (i.e., with more advanced reliable pump technology) with a baseline rate of severe hypoglycemia of >10 episodes/100 patient-years and at least 6 months of CSII use—showed that pump therapy was associated with a 2.9-fold (95% confidence intervals 1.45–5.76) reduction in severe hypoglycemia. This reduction in frequency of severe hypoglycemia during CSII compared with MDI occurred despite a lower mean HbA1c.¹⁴ This study also found that the benefit from pump therapy was greater in individuals with higher rates of severe hypoglycemia (P < 0.001), older age (P = 0.019), and with longer duration of diabetes (P = 0.025).¹⁴ Another recent meta-analysis, commissioned by the Endocrine Society, has reached different conclusions that CSII is not associated with a significant reduction in severe or nocturnal hypoglycemia compared to MDI.¹⁵ The strength of these conclusions are limited by the inclusion of shorter duration studies with a low incidence rate of severe hypoglycemia that would bias against the detection of any significant potential benefit from pump therapy. In addition, this meta-analysis included studies that used intermittent fingerstick glucose monitoring to determine rates of minor and nocturnal hypoglycemia, and because intermittent monitoring can be unreliable in detecting nocturnal hypoglycemic events,¹⁶ these studies would be relatively insensitive to detecting treatment-related differences. Furthermore, the studies examined in this analysis were almost entirely performed using older pumps, which did not have advanced features such as the bolus calculator software that can limit hypoglycemia related to dose stacking from repeated boluses. These factors limit the relevance of the conclusions from this analysis to clinical decision-making, and the weight of evidence from the literature suggests that motivated patients with type 1 diabetes with recurrent hypoglycemia and especially a history of severe hypoglycemia would benefit from a trial of insulin pump therapy.

Quality of Life Benefits and Patient Expectations

Many patients describe improved quality of life with pump therapy. However, there have been few carefully designed studies examining differences in psychosocial functioning with CSII compared to MDI and of patient perspectives of pump therapy.^3,17 The published literature points to better quality of life with use of pumps^18
–20; however, this has not been confirmed in all studies.²¹ Patients will vary in their perceptions about the trade-offs between potential quality of life benefits (including increased lifestyle flexibility, dietary freedom, reduced fear for hypoglycemia) relative to some of the potential negatives associated with using a pump (including body image concerns and the need for frequent blood glucose monitoring).²² We conducted a focus group investigation of 30 patients followed at our center to examine how psychosocial factors impacted on use of the pump.²³ The analysis revealed that individuals with better glycemic control viewed the pump as a tool for diabetes self-management rather than a panacea. In contrast, the pump patients with poorer HbA1c had more unrealistic expectations, including the perception that use of technology was a substitute for attentiveness to self-care and that pump therapy allowed them to do whatever they wanted, particularly with regard to eating. These findings highlight the need for health professionals to assess patient expectations before the initiation of pump therapy so that unrealistic notions (often promoted by marketing materials) can be dispelled. The successful patient will recognize that while the pump allows life with diabetes to be more flexible and convenient, it is not a vehicle for total freedom from diabetes.

Use of Different Bolus Types with Pump Therapy

There are a several bolus options for the savvy CSII user: single-quick-easy bolus, split-two bolus, delayed-extended-square wave, and combination-multiwave. The rationale behind these various options is to help patients realize the most accurate way to infuse insulin to match the meal-related glycemic excursion and thus better control postprandial blood glucose levels. This ability to tailor the bolus delivery makes sense in the real world with a multitude of factors influencing glycemic control: duration of meals, type of meal (low/high glycemic index [GI]), amount of carbohydrates, preparation (fried or grilled), and time of day.²⁴ However, there is a paucity of trial data addressing when a specific type of bolus is best used. In one study a standard high fat meal of coke, pizza, and tiramisu was given to nine young C-peptide-negative patients with type 1 diabetes, and the lowest 90-min postprandial glucose was achieved with a dual-wave bolus, followed by single-bolus, then double-bolus. Square wave was the least effective. The incidence for hypoglycemia was similar with all four types of insulin bolusing.²⁵ There have been other studies evaluating the best type of bolus to use with a high fat meals (e.g., pizza), which have showed better glycemic control with dual-wave bolus; some studies also indicated a longer dual-wave bolus, such as over an 8-h period rather than over a 4-h period, may work best with high fat meals.^26,27 These studies have several shortcomings, such as small sample size, uncontrolled variable preprandial glucose levels, infrequent and inadequate duration of blood glucose level measurements, and limited data on insulin levels and hypoglycemia.²⁴ In addition to high fat meals, variable GI can also contribute to the challenges in achieving good postprandial blood glucose control. A study of 20 young patients with type 1 diabetes given a combination of meals of low and high GI over four study days showed that dual-wave bolus before a low GI meal decreased the area under the curve in the postprandial glucose profile by up to 47% (P = 0.004) and that the dual-wave bolus also had a lower risk for hypoglycemic events for the same premeal glucose (P = 0.005) compared with the standard bolus.²⁸

Practical Issues to Consider in the Pump Patient with Erratic Glucose Control

There are a range of pump-specific issues to consider in the patient presenting with erratic glucose control:

The clinician should routinely examine the infusion sites of pump users. Infusion site problems including scarring and lipohypertrophy are not uncommon causes for erratic glucose levels, especially in the long-term pump user.

The clinician should routinely enquire if the patient has been experiencing catheter kinking or dislodgement. Plastic catheters that are perpendicular to the skin surface and have a small base for attachment (such as the Medtronic [Northridge, CA] MiniMed Sofset™ and the Disetronic Medical Systems [Fishers, IN] Ultraflex™) are more prone to kink or become dislodged, especially with activity/perspiration. Solutions include use of antiperspirants or changing to metal needle infusion sets, plastic sets with a shorter cannula, or other types of plastic infusion sets that are less prone to kinking. These include the Medtronic MiniMed Quickset™ (which has a broad base of attachment to the skin), and sets that insert obliquely such as the Medtronic MiniMed Silouette™, Roche Disetronic Tender™, and Animas [West Chester, PA] Comfort™. Note of caution: Practical experience indicates that use of insertion devices (such as the MiniMed Sil-serter [Medtronic]) for placement of oblique catheters is often associated with erratic glucose control, presumably due to tissue trauma; patients should be encouraged to insert these oblique catheters manually. A recent study comparing different catheter types showed that within 48 h after the insertion of Teflon^® (Dupont, Wilmington, DE) catheters there was a significant change in adipose tissue blood flow (2.1 ± 0.3 to 2.8 ± 0.4 mL/100 g/min, P = 0.009) and the infusion pressure (3.32 ± 0.09 to 3.53 ± 0.11 Pa, P = 0.02) required for bolus administration.²⁹ Steel catheters did not exhibit these changes, and the investigators hypothesized that these differences in blood flow and infusion pressure may be due to steel having better biocompatibility with less inflammatory protein deposition. While the clinical relevance of these findings are not clear, they do point to the potential value of giving patients using Teflon catheters who are experiencing erratic glucose control a trial period with steel catheters.

The clinician should routinely enquire if the patient changes the pump reservoir and infusion system on a regular basis and should check if there is a tendency for elevated and erratic glucose in the period preceding infusion set changes. There is evidence from glucose clamp studies that insulin kinetics and dynamics change with increasing age of infusion site.³⁰ In a study that compared the same bolus of insulin delivered through an infusion set at 12 h and 84 h post-insertion, it was shown that with more prolonged use of an infusion site there was an earlier peak with shorter duration of action, which the investigators hypothesized was the result of increased blood flow around the infusion site due to changes in the surrounding microvascular environment.³⁰ Insulin instability in the pump infusion system can manifest as erratic glucoses or even precipitation in the infusion system.³¹ A recent study comparing insulin stability in pumps placed in an incubator set at a temperature to 32–36°C to simulate the clinical environment showed an increased rate of catheter occlusions from day 3 to day 5 with more occlusions for glulisine compared to lispro and aspart insulin.³² While the results from this laboratory study may not have direct relevance to clinical decision-making, practical experience teaches us that some patients with erratic glucose levels who are prescribed a change in insulin type and/or more frequent catheter/infusion system changes will demonstrate improved glycemic control. Practices need to be individualized, and some patients with stable and good glycemic control can safely use reservoirs and catheters for longer than mandated by the label. Poor reimbursement of pump supplies by insurance companies is sometimes a factor underlying these practices.

Review of pump downloads can be helpful in the evaluation of the patient with suboptimal glycemic control:

Check priming history to assess how frequently the infusion system is being changed

Check bolus history to detect possible missed meal boluses

Check percentage of basal to bolus insulin: a high percentage of basal insulin in the patient with frequent hyperglycemia may indicate that bolus doses are frequently being missed, whereas a high percentage of basal insulin in the patient with frequent hypoglycemia may indicate that high basal rates are contributing to hypoglycemia and would point to need to re-evaluate basal rate settings.

Check for history of pump suspension or basal rate reduction. Even temporary removal of the pump to bathe can lead to elevations in the glucose levels; patients need to be reminded to bolus to replace the missed basal when reconnecting the pump. Some pump patients will get in the practice of reducing the basal rate or suspending the pump when they are hypoglycemic; the end result will often be exaggerated rebound hyperglycemia.

The insulin pump can be a very effective tool for optimizing glucose control in the motivated adult patient with type 1 diabetes. The art in clinical medicine is in applying the evidence from research to individualize care. In this article we have covered some of the specific indications and factors that the clinician should consider in individualizing the choice between CSII and MDI and have outlined some of the pump-specific practical issues that need to be a focus in the follow-up care of some patients. The initial training and follow-up care of the patient who starts on an insulin pump can be time-consuming and demanding for the busy clinician. Lack of support staff to assist in this process sometimes underlies the reluctance of clinicians to promote the use of pump therapy. It needs to be appreciated that the demands of this more intensive initial training period are often counterbalanced in the long term; once the improved stability in glycemic control that comes with pump therapy has been realized, it is not uncommon for pump users to make fewer demands on the busy clinician than when they were on intensive injection therapy.

Further widespread adoption of insulin pump therapy in diabetes care could be impeded unless healthcare reform addresses the need for appropriate reimbursement for the higher level of caregiver training and time needed to provide guidance to the patient starting on pump therapy. The cost-containment initiatives recently introduced by several commercial insurers that rank physician “efficiency” based solely on the cost of care delivered, rather than cost-effectiveness, are especially short-sighted in this regard. These reimbursement changes penalize committed healthcare professionals who promote use of intensive insulin therapy and technology such as pumps that can prevent long-term diabetes complications and related medical costs. Unless healthcare reform realigns these incentives, the infrastructure required to support patients in the training and use of insulin pumps will further decline, and fewer patients will be able to realize the benefits of this technology.

Appendix: Individualizing the Choice Between Pump Therapy and MDI: Indications and Considerations

Severe hypoglycemia and hypoglycemia unawareness

A1c above goal. Caution: Intentional insulin omission (to facilitate weight control) is a not uncommon cause for poorly controlled diabetes, especially in young women.³³ Before inititiating pump therapy it is important to rule out this problem. These patients habitually underdose insulin; because of chronic hyperglycemia they do not routinely troubleshoot for insulin non-delivery by the pump and can therefore be at increased risk for developing ketoacidosis.

Diurnal variations in basal insulin requirements due to the dawn phenomenon^34,35 and steroid therapy can be more readily managed using the multiple basal rates provided by the pump than the long-acting injected insulins.³⁶ There is considerable interindividual variability in the extent of the dawn phenomenon.³⁴ From a physiologic standpoint, patients with a marked dawn phenomenon who are striving for intensive glycemic control would benefit from pump therapy: the variable basal rates provided by the pump allows for step up in basal insulin delivery to suppress the dawn phenomenon without increasing the risk for hypoglycemia during the early nocturnal hours when most individuals are more insulin sensitive. The diurnal differences in insulin sensitivity due to oral steroids are more readily managed with pump therapy than with long-acting basal insulins, such as glargine. Renal transplant patients taking as little as 5 mg of prednisone in the morning will usually have discernible diurnal variability in basal insulin (with increasing requirements during the afternoon and evening period, and lower requirements overnight and in the morning). The multiple basal rates provided by the pump can facilitate much tighter glyemic control with less risk of hypoglycemia in these patients.

Preconception and pregnancy

Practical advantages of pumps for bolus insulin delivery:

a. Dosing precision. The extra precision of insulin dosing with pumps can be an important advantage for adults and young children (especially infants and neonates),³⁷ who are very insulin sensitive and therefore require very low insulin doses. Accurate dosing of insulin boluses in fractions of a unit allows the patient to more precisely correct hyperglycemia without overshooting leading to hypoglycemia. For those patients in whom fear of hypoglycemia is an impediment to tight glucose control, this added assurance can be critical in overcoming reluctance to taking extra boluses required to correct hyperglycemia.

b. Ease of bolusing. In practice, pumps can be helpful (1) to reduce missed food boluses, (2) to facilitate interprandial “correction” bolusing, and (3) eating at restaurants and on social occasions (with use of extended/square-wave boluses and multiple bolusing).

c. Optimizing postprandial insulin coverage for higher fat, complex carbohydrate, and/or larger meals. Dietary fat delays gastric emptying³⁸ and induces postprandial insulin resistance,³⁹ and high fat meals can usually not be adequately covered using a single injection of rapid-acting insulin.⁴⁰ Use of the extended/dual-bolus and increased temporary basal can help optimize postprandial glycemic control following these meals^25
–27 (for practical strategies see Wolpert¹⁰). A prolonged bolus will similarly be of value with complex lower GI carbohydrates (such as pasta) that are slowly digested, in those rare patients who exhibit a marked delay in gastric emptying with large meals. The use of injection therapy in these circumstances can lead to early postprandial hypoglycemia (due to insulin action preceding carbohydrate absorption) followed by late postprandial hyperglycemia.

d. Gastroparesis. Use of the extended/dual-wave bolus can allow for better matching of carbohydrate absorption and insulin action.

Potential benefits of pumps for weight control with intensive therapy. Concern about weight gain can be an impediment to intensification of glycemic control in some patients.³³ In the Diabetes Control and Complications Trial the intensively treated patients gained an average of 4.8 kg more than the patients who received conventional therapy, and over 30% of the patients in the intensive treatment cohort developing significant weight gain (defined as >5 kg/m²).⁴¹ In selected patients pump therapy can be of benefit in weight control, and this has been demonstrated in a nonrandomized, case-controlled study in adolescents with type 1 diabetes.⁴² Three groups of adolescents with type 1 diabetes were followed prospectively: (1) CSII, instructed in weight control strategies; (2) CSII, no focus on weight control; and (3) MDI control group. In the first 6 months after starting CSII the adolescents who received specific instruction in weight control strategies were able to lose weight, whereas for patients in other groups there was no change. With CSII the patient can more readily reduce insulin levels during exercise by using the “temporary” basal or by disconnecting the pump; this reduces the need for carbohydrate loading to prevent exercise-induced hypoglycemia, allowing the patient to use exercise more effectively as a strategy to burn off calories. Use of the temporary basal during routine physical activities (such as yard- or housework) that may not be regarded by some patients as “exercise” can lessen the need for unwanted snacking. Clinicians need to keep a caveat in mind: with rare patients the ease of bolusing with the pump can facilitate overeating and lead to excessive weight gain.

Footnotes

Author Disclosure Statement

H.W. is a consultant for Insulet. G.S. declares no competing financial interests exist.

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Insulin Pump Use in Adults with Type 1 Diabetes—Practical Issues

Abstract

Benefits and Risks of Pump Therapy

Hypoglycemia and Pump Therapy

Quality of Life Benefits and Patient Expectations

Use of Different Bolus Types with Pump Therapy

Practical Issues to Consider in the Pump Patient with Erratic Glucose Control

Appendix: Individualizing the Choice Between Pump Therapy and MDI: Indications and Considerations

Footnotes

Author Disclosure Statement

References