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Are Insulin Pumps Underutilized in Type 1 Diabetes? Yes

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Are Insulin Pumps Underutilized in Type 1 Diabetes? Yes Editorials POINT-COUNTERPOINT (SEE P. 1453) Are Insulin Pumps Underutilized in Type 1 Diabetes? Yes ontinuous subcutaneous insulin in- also a key determinant of cost effective- glycemia without stipulating what “re- fusion (CSII), popularly called insu- ness, the estimates of which are limited peated” means. A recent cross-sectional C lin pump therapy, has evolved from (8). study of 1,076 consecutive adult type 1 its invention in the 1970s as an experi- diabetic patients treated according to mental treatment designed to test the re- The problem of severe hypoglycemia modern guidelines at four centers in the lationship between glycemic control and Reduction of severe hypoglycemia (where U.K. and Denmark is informative in this diabetic tissue complications (1) to its third-party assistance is required for re- respect (16). As many as 21% had two or present status as a routine therapy for se- suscitative measures) in type 1 diabetes more severe hypoglycemic episodes in the lected type 1 diabetic patients (2). How- was first identified in the mid-1980s, ei- previous year, as compared with a mean ever, the use of insulin pump therapy ther with matched groups of injection- or of 13% suffering severe hypoglycemia in varies markedly throughout the world; pump-treated type 1 diabetic subjects (9) the previous year over a 12-year study of there are some notable high-use coun- or in a randomized controlled trial of mul- an intensified insulin program in Ger- tries, e.g., the U.S. and Israel, where it is tiple insulin injection (MDI) therapy (and many (17). However, the definition of hy- estimated that ϳ20% of type 1 diabetic nonoptimized injection therapy) versus poglycemia here was the requirment of patients use CSII (manufacturers’ esti- CSII (the Oslo Study [10]). Many subse- intravenous glucose or glucagon injec- mates), whereas in other countries, such quent studies have confirmed the hypo- tion, so the frequency of hypoglycemia as the U.K. and Denmark, ϳ1% use glycemia-reducing effect of insulin requiring any assistance would be higher. pump therapy (3). pumps (2,11–13), with typical reduc- The reasons for this variation include tions in frequency of severe hypoglycemia Yet the distribution of severe hypoglyce- the availability of financial resources and ϳ mia in the type 1 diabetic population is of 70% compared with MDI. ϳ health care professionals to supervise CSII The clinical impact of this beneficial extremely skewed, with 5% of patients and a lack of knowledge on the effective- effect was undervalued until recently be- having 70% of all episodes (16). This ness of CSII (3), but there is also disagree- cause of the untypically high frequency of therefore represents a reasonable mini- ment on which diabetic subjects should severe hypoglycemia reported in the mum target group, although many more be treated with CSII, as evidenced by both pump-treated subjects in the Diabetes might suffer hypoglycemia, which is dis- the different intercountry usage and the Control and Complications Trial (DCCT) abling for them. large number of reasons for starting insu- (0.5 vs. ϳ0.1–0.25 episodes/patient-year lin pump therapy (4–6). in other pump studies) (14). The expla- As noted by Schade and Valentine (7), nation for this discrepancy is unclear but The impact of long-acting insulin “the challenge for the health care provider may relate to a large number of centers in analogs on severe hypoglycemia is to select the diabetic patients who will the DCCT that were using pump therapy There is no strong evidence that using really benefit from pump usage.” What for the first time. glargine or detemir insulins (with their proportion and what types of type 1 dia- flatter profile and improved predictabil- betic patients should then be offered a Frequency estimation for severe ity), instead of isophane-based regimens, trial of CSII on clinical grounds alone, hypoglycemia will reduce the frequency of severe hypo- leaving aside the legitimate issues of sup- Estimating the proportion of type 1 dia- glycemia (18). Although minor hypogly- ply on the basis of patient preference and betic subjects with severe hypoglycemia is cemia during the night is less with long- restrictions due to availability of funding difficult because it critically depends on acting analogs, there is no difference in and staffing? I shall argue that the target patient selection. Many factors influence the rate of severe hypoglycemia when an proportion best treated by CSII, or offered hypoglycemia frequency (15,16), includ- MDI regimen using isophane as the basal a trial of CSII, can be derived from an ing the definition of severe hypoglycemia insulin is compared with either glargine- estimate of the effectiveness of this ther- (e.g., requiring any assistance or, specifi- based (18,19) or detemir-based (20–22) apy compared with the best insulin injec- cally intravenous glucose/glucagon injec- injection regimens. Severe hypoglycemia tion treatment for particular clinical tion), the type of treatment (intensive over extended periods has not been well problems in type 1 diabetes. versus conventional regimens), prevailing studied in randomized trials directly com- Most current guidelines (4,6) or re- glycemic level, diabetes duration, con- paring glargine-based regimens and CSII views of the evidence base on CSII (2) do comitant drug usage, alcohol intake, pres- not take into account recent studies on ence of autonomic neuropathy and renal because of the relatively short-term na- the effectiveness of pump therapy in the disease, smoking, educational level, and ture of the studies (23–25). However, putative target groups of hypoglycemia- history of previous hypoglycemia and hy- since severe hypoglycemia does not ap- prone diabetes and the worst controlled poglycemia awareness. pear, based on current evidence, to be re- subjects or the possible impact of recently A further issue is the judgement about duced with MDI, based on long-acting introduced long-acting insulin analogs on what frequency of hypoglycemia is dis- insulin analogs compared with isophane the quality of control achievable with in- abling. Some guidelines for insulin pump regimens, the use of CSII to improve hy- jection therapy. The efficacy of CSII in the therapy (6) define this as the “repeated poglycemia frequency during MDI is still most appropriate groups of patients is and unpredictable occurrence” of hypo- justified. DIABETES CARE, VOLUME 29, NUMBER 6, JUNE 2006 1449 Point-Counterpoint The problem of hyperglycemia and The impact of glargine and detemir The problem of the dawn elevated glycated HbA1c on MDI on hyperglycemia phenomenon Until recently, the belief was that the dif- Though there may be lowered fasting The dawn phenomenon refers to the rise ference in average glycemia achievable on blood glucose concentrations, overall gly- in blood glucose concentration in some pump therapy was relatively small com- cemia as measured by A1C is usually not diabetic patients occurring in the few pared with MDI (2,6,26). For example, a improved by glargine or detemir com- hours before breakfast, without preced- meta-analysis of 12 randomized con- pared with NPH-based injection regi- ing hypoglycemia; it is thought to be due trolled trials indicated that glycemic con- mens in type 1 diabetes (18,19,21,22,32). to a combination of insulin resistance trol on pump therapy was slightly but In studies comparing glargine with pump caused by surges in growth hormone dur- significantly better than on MDI, with a therapy, A1C or fructosamine values were ing the night and insulin deficiency difference in HbA1c (A1C) of 0.5% and improved on CSII versus glargine caused by waning of the effects of the pre- mean blood glucose concentration of 1 (23,24,32), but in relatively well-controlled ceding evening’s insulin injection (33). mmol/l (26). However, recent work from subjects, A1C percentages were similar Increasing the evening long-acting insulin several groups, including a pooled analy- (25). Thus, the evidence to date indicates dose or delaying its injection to bedtime sis of randomized controlled trials, has that long-acting insulin analog–based injec- to extend action are useful strategies for shown that the fall in A1C on switching tion regimens are not as effective as pump treating the dawn phenomenon, but both type 1 diabetic subjects who have failed to therapy in lowering glycemia in most can lead to nocturnal hypoglycemia. The achieve good control on MDI to CSII is poorly controlled type 1 diabetic patients, phenomenon can be successfully man- directly proportional to the initial A1C on and the target group with elevated A1C on aged by CSII because the basal insulin in- MDI (27–29). Thus, the best improve- injections suitable for a trial of CSII will fusion rate can be preset to increase ment is seen in the worst-controlled sub- remain at ϳ15%. during the dawn hours (33). jects (who are the likely candidates for The frequency of the dawn phenom- pump therapy), a fact that was obscured enon during MDI is difficult to judge. Rel- in previous trials of unselected, general The syndrome of hyperglycemia, atively few patients are referred to our type 1 diabetic patients without clinical blood glucose variability, and specialist pump clinic because of a problems (26). When, for example, the unpredictable hypoglycemia marked dawn phenomenon and probably starting A1C is 10% on MDI, the fall in Who are the patients who remain hyper- many can now be managed by glargine or A1C on switching to CSII is likely to be glycemic on MDI? It might be thought detemir regimens, which are often very ϳ2% but, in a relatively well-controlled effective at lowering fasting blood glucose that elevated blood glucose concentra- subject with an A1C of 7%, the difference without increasing hypoglycemia (18– tions can be obviated by increasing the in A1C could be Ͻ0.5% (28).
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