What Are the Goals and Risks

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The blood glucose goals of the American Diabetes Association (9,10) are shown in Table 2. The listed HbA,c of less than 7% is accepted around the world based on the findings of the Diabetes Control and Complications Trial (DCCT) performed in type 1 diabetes (see Table 3), which showed an acceptable balance of protection against microvascular complications versus risk of severe hypoglycemia with this HbAlc level (1). Equally important is to prevent rigidity of lifestyle by providing flexibility for exercise, sports, diet, work, travel, or whatever the patient wants for a happy life.

The caregiver also needs to know the risks and problems with intensive insulin therapy so they can be openly discussed with the patient. Best known is the potential for hypoglycemia. The DCCT reported a threefold increase in severe hypoglycemia, which was defined as requiring aid from someone else, and a threefold increase in hospitalization for hypoglycemia, in patients with HbA]c of 7.2% versus 8.9% (1). Several subgroups were at particularly high risk: adolescents, males, those without residual c-peptide, and those with a prior history of severe hypoglycemia (11). The most important clinical predictor for high-risk patients is the presence of hypoglycemia unawareness—patients report that their reactions have changed so they no longer feel the sweats, shakes, or pounding heart (i.e., loss of the catecholaminergic symptoms) but instead experience

Table 2 Goals for Glycemic Control Recommended by the American Diabetes Association

Normal

Goal

Additional action suggested

Whole-blood values (mg/dl)a

Average preprandial

<100

80-120

<80, >140

Average bedtime glucose

<110

100-140

<100, >160

Plasma values (mg/dl)b

Average preprandial

<110

90-130

<90, >150

Average bedtime glucose

<120

110-150

<110, >180

HbAlc(%)c

<6

<7

>8

■ Measurement of capillary blood glucose. b Values calibrated to plasma glucose. c HbA1c is referenced to a nondiabetic range of 4.0-6.0%. Source'. Ref. 9.

■ Measurement of capillary blood glucose. b Values calibrated to plasma glucose. c HbA1c is referenced to a nondiabetic range of 4.0-6.0%. Source'. Ref. 9.

Conventional

Results

Retinopathy

Nephropathy

Table 3 The Diabetes Control and Complications Trial Design

Intensive regimen Minimum of three shots/day or a pump (35% used a pump)

Four blood glucose measurements/day +1/week at 3 a.m.

Blood sugar guidelines 70-120 mg/dl (3.9-6.7 mM) before meals <180 mg/dl (10 mM) 1-2 hr after a meal >65 mg/dl (3.6 mM ) at 3 a.m. Attained HbAlc of 7.2% (normal <6.05%) One or two insulin injections/day, no or only occasional self-blood-glucose monitoring Attained HbAlc of 8.9%

Primary intervention: 50% incidence with conventional, 15% incidence with intensive therapy

Secondary intervention: 54% less progression with intensive therapy and 54% less need for laser therapy with intensive therapy Primary intervention: rare events, not significant Secondary intervention to microalbuminuria: 40% conventional, 25% intensive, and to overt proteinuria: 10% conventional, 5% intensive Overall, 35% less microalbuminuria, 54% less proteinuria

Primary intervention: 10% conventional, 3% intensive

Secondary intervention: 16% conventional, 7%

intensive Overall, 61% reduced

No statistical difference between conventional and intensive treatment groups because too few events in either group—44% fewer events in intensive group

Intensive group gained an average of 10 lb (4.5 kg)

versus 5 lb in conventional group Threefold increased incidence of severe hypoglycemia

The DCCT (1985-1993) assessed the relationship in type 1 diabetes between blood glucose control and development/progression of microvascular complications. There were two groups: primary intervention (up to 5 years of diabetes with no known retinopathy) and secondary intervention (up to 15 years of diabetes with mild retinopathy). Source: Ref. 1.

Neuropathy

Macrovascular

Problems

Weight gain

Hypoglycemia

subtle changes in mentation, ability to concentrate, or personality (discussed in Chapter 13). Its presence is not necessarily a contraindication for intensive insulin therapy, but these patients must be watched carefully for blood sugars of 30 or 40 mg/dl in their logbooks that may not be perceived by the patient as particularly problematic. Also, as extensively discussed in Chapter 13, recurrent hypoglycemia has been identified as an important cause of the impaired insulin counterregu-lation that leads to hypoglycemia unawareness. Indeed, it was observed some years ago that intensive insulin therapy elicited this effect in otherwise healthy patients with type 1 diabetes (12,13). However, as the importance of hypoglycemia's impairing insulin counterregulation became known, prevention of hypoglycemia became a prime goal when practicing intensive insulin therapy. Further, it is now understood that intensive insulin therapy is based on physiological insulin delivery that mutes both the hyper- and hypo- swings in glycemia. Indeed, a basal-bolus regimen is now often recommended for patients who are experiencing major hypoglycemia. Patients need a balanced discussion of this issue. For some, fear of hypoglycemia can be a major issue that stops them from fully following the prescribed diet and insulin program. They need to know that this may, paradoxically, worsen swings in glycemia and problems with hypoglycemia. Also, preventive measures need to be in place. Patients should be taught that alcohol and exercise can promote hypoglycemia, a bedtime snack is strongly recommended, and a glucagon emergency kit should be kept in the house and perhaps at work. To summarize, in many patients, an intensive insulin regimen has no major detrimental effect and may even alleviate problems with hypoglycemia.

The DCCT noted an average 10-pound weight gain in the intensively treated group versus 5 pounds in the group with conventional treatment (1). Patients with type I diabetes are usually of relatively normal weight and share the same body consciousness as young people in general—weight gain (or fear thereof) at times is the main factor that limits a patients willingness to undergo intensive therapy. The weight gain is multifactorial, including lessening of glycosuria, increasing calorie intake to treat or prevent hypoglycemia, and reversing the catabolic effect of poorly controlled diabetes. As glycemia is optimized, it is important to work with a dietitian to develop a meal plan for weight maintenance. Also, a major focus of "tweaking" the regimen once it has been started is to minimize hypoglycemia. In addition, it should be pointed out to the patient diat basal-bolus regimens generally minimize or eliminate between-meal snacks, which helps with weight control.

Intensive glycemic control occasionally worsens pre-existing retinopathy (14), but the effect is generally short-lived and without functional significance although proliferative retinopathy and blindness have rarely been reported. It is suggested that patients with known retinopathy be evaluated by an ophthamolo-gist prior to starting an intensive insulin program, and frequently thereafter.

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