Intensive Insulin Therapy

In patients with DM1 and deficiency of endogenous insulin production, the exogenous insulin regimen will be designed to simulate as closely as possible the multiphasic profile of insulin secretory responses to meals and snacks present in normal subjects in order to enable targeted glycemic control. The term intensive insulin therapy is used to describe more complex insulin administration regimens in which basal insulin therapy is combined with bolus doses of insulin given three or more times daily timed to correspond with ingestion of meals and/or snacks. When the intensive insulin therapy is delivered by SC injection, the regimen is known as a multiple daily injection (MDI) regimen. Intensive insulin therapy is also delivered by continuous subcutaneous insulin infusion (CSII) using an external insulin pump. Currently in the United States, approximately 25% to 30% of persons with DM1 are treated with insulin pumps.

In MDI, basal insulin is delivered as once or twice daily long-acting or twice daily intermediate-acting insulin and in CSII basal insulin is delivered in continuous fashion. In both MDI and CSII, bolus/meal insulin is delivered as discrete doses in conjunction with food intake, by shot in the MDI regimen and by activation of a bolus for delivery by the insulin pump in CSII.

In one trial comparing CSII using insulin aspart versus MDI with insulin aspart and glargine, CSII therapy resulted in lower glycemic exposure [40% lower for CSII than MDI as measured by area under the curve (AUC) glucose > 80 mg/dL and AUC glucose > 140 mg/dL] without increased risk of hypoglycemia [CSII: 92% (73% for nocturnal hypoglycemia), MDI: 94% (72% for nocturnal hypoglycemia)], as compared with MDI (93).

Considerations in the Decision to Intensify Insulin Therapy

As mentioned earlier in this chapter, studies suggest that intensive therapy should be started as early as possible following the diagnosis of DM1 and that it has clear benefits for patients with DM1 when implemented at any time in the course of the disease. It is important to consider the practical aspects of such a regimen in the discussion with the adult patient with DM1 who is to intensify insulin therapy. Following are the issues for consideration:

• A commitment by the patient to follow the regimen is required. It will be necessary to manage and coordinate diet, activity, insulin administration, and BG monitoring. Algorithms for insulin administration in MDI management of DM1 involve frequent monitoring of the BG concentration, generally at a frequency of four or more times per day.

• The incidence of hypoglycemia may be increased up to threefold in patients with DM1 managed with intensive insulin regimens (94).

Weight gain is more likely with intensive insulin therapy regimens, which can limit patient compliance, particularly in women. Addition of pramlintide (Symlin®) to the therapeutic regimen can help mitigate postprandial hyperglycemia and may allow weight loss rather than gain as hyperglycemia is controlled in some patients. Its ability to increase satiety, slow gastric emptying, and suppress glucagon secretion can impact postprandial hyperglycemia when used in combination with insulin therapy. (Pramlintide is discussed fully in Chap. 6.)

• The cost of intensive insulin therapy is about three times that of conventional treatment, based upon an analysis of the DCCT (95). On the other hand, intensive therapy is associated with a lower incidence of costly chronic complications. Formal economic analyses have demonstrated that intensive therapy is cost-effective for the treatment of diabetes (96).

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