What should be done with regard to the glycaemic control of this patient

The patient obviously manifests secondary failure of the oral antidiabetic drug treatment. The diagnosis of DM was done 15 years before, she receives almost the maximal dose of glibenclamide and her body weight is only slightly increased. The above data suggest a serious disturbance of insulin secretion. The addition of a second medicine (for example, metformin) is not expected to decrease HbA1c more than 1.5 percent. The beginning of insulin treatment was recommended to the patient, but she explicitly refused. After instructions were once again given regarding proper diet and mild increase in physical activity, metformin was added to the treatment at an initial dose of 850 mg daily and later 1700 mg daily (one pill morning and evening, after the meal).

The patient returned after eight months. Her symptoms had not receded and her HbA1c was 9.8 percent. She now accepted the treatment with insulin.

Due to the high level of HbA1c and since it was considered that a significant degree of insulin secretory impairment from the pancreas exists, it was preferred to administer both basal and 'prandial' insulin right from the beginning, in the form of a fixed mixture, morning and evening. The choice of the mixture depends on the age of the patient, his or her compliance, the dietary schedule and the glucose levels as shown from the self-monitoring measurements. In this particular case a mixture of 30 percent regular insulin and 70 percent intermediate-action (NPH) insulin was initially preferred.

Calculation of the dose was as follows. 0.5 units insulin per kilogram of body weight were calculated to be necessary, that is 34 units of insulin (0.5 x 68), daily. Because it was decided to continue the metformin (at a dose of 850 mg daily), 15 percent of the insulin units were removed, that is five units, and finally 29 units of insulin were administered. Because the patient reports that her dinner is not particularly rich, the units were initially distributed as two thirds (19 units) in the morning, before breakfast, with the remainder (10 units) before dinner. It was stressed to the patient that the administration of insulin renders the self-monitoring of blood glucose with a meter essential (see Chapter 4). Proper advice on the suitable content and timing of the meals was given (Figure 28.4a). After discussion with the patient, the targets for the glycaemic control were set: for fasting glucose, <120 mg/ dl (6.7 mmol/L); for post-prandial glucose, < 180 mg/dl (10.0 mmol/L); and for bedtime glucose, < 140mg/dl 7.8mmol/L), as well as HbA1c < 7.0 percent.

The next meeting was arranged for one week, when the patient brought the following measurements (the values of the last three days are shown [in mg/dl (mmol/L]).

Breakfast

Lunch

Dinner

2 hrs

2 hrs

2 hrs

Date

Pre

after

Pre

after

Pre

after

Bedtime

16/6

256

199

203

229

226

216

(14.2)

(110)

(113)

(12.7)

(12.5)

(12.0)

17/6

224

178

219

(12.4)

(9.9)

(12.2)

18/6

230

218

198

207

(12.8)

(12.1)

(110)

(115)

Based on the above measurements, the dose of the morning insulin was increased by six units, so that the blood glucose levels two hours after the breakfast are improved (increase of the regular insulin by 1.8 units) as well as those after lunch (increase of intermediate-acting insulin by 4.2 units). The dose of the evening insulin was also increased by two units.

Twenty days later, the patient's measurements were as follows (the values of the last three days are shown [in mg/dl (mmol/L]):

Breakfast

Lunch

Dinner

2 hrs

2 hrs

2 hrs

Date

Pre

after

Pre

after

Pre

after

Bedtime

7/7

145

148

177

165

(8.1)

(8.2)

(9.8)

(9.2)

8/7

148

132

156

(8.2)

(7.3)

(8.7)

9/7

133

182

141

(7.4)

(10.1)

(7.8)

Most measurements now approach the set targets. Insulin was increased by two units in the morning and evening. A follow-up appointment was arranged for one month, when the measurements (of the three last days) were as follows (in mg/dl [mmol/L]):

Breakfast Lunch Dinner

2 hrs 2 hrs 2 hrs

Date Pre after Pre after Pre after Bedtime

29/7 117 99 224 132

30/7 99 178 144

31/7 114 111 200

The vast majority of the measurements are now within therapeutic targets (bold letters). The patient notes that the high values are due to aberrations in diet. Three months after the beginning of insulin, the HbA1c was measured at 6.7 percent. The continuation of the same treatment and follow-up were recommended.

CASE STUDY 4

A 72 year old man with Type 2 DM for 12 years, who is obese (weight: 90 kg [198.4 lb], height: 1.70 m [5 ft 7 in], BMI: 31.2 kg/m2), receives treatment with oral antidiabetic medicines: glimepiride 4 mg daily (in the morning) and metformin 2,550 mg daily (850 mg tablets morning, midday, evening). He regularly checks his blood sugar levels with a portable glucose meter. His DM control over the past few years has always been satisfactory (HbA1c: 6.5-7.3 percent). However, over the last eight months he has observed a progressive increase in the blood glucose levels, and the last two HbA1c measurements, three months apart, were 7.8 percent and 8.3 percent (the most recent). His diet frequently deviates from the frame of instructions he has been given, because 'he likes good food'. He also has hypertension (under pharmaceutical treatment, with good control) and hyperli-pidaemia (under treatment with a statin). His self-monitoring diary shows the following measurements for the last three days (in mg/dl [mmol/L]):

Breakfast

Lunch

Dinner

2 hrs

2 hrs

2 hrs

Date

Pre after

Pre

after Pre

after Bedtime

5/11

187

200

194

(10.4)

(111)

(10.8)

6/11

223

188

227

(12.4)

(10.4)

(12.6)

7/11

209

179

210

(116)

(9.9)

(11.7)

The patient is receiving the maximal metformin dose together with a big dose of sulfonylurea and yet is not well controlled. Over the last six months he tried to decrease his weight by reducing the in- take of calories and by slightly increasing his walking time, but he failed.

This patient has an indication for insulin treatment. He has had known DM for 12 years, receives a combination of a sulfonylurea with metformin in large doses and his control is inadequate (HbA1c >8 percent). He has repeatedly received lifestyle intervention instructions, without any success. It was decided to stop glimepiride, to retain metformin and to add insulin of intermediate or slow action before bedtime. The evening insulin injection substitutes the basal secretion of insulin and usually suffices for the correction of hyperglycaemia when residual secretion from the b-cell exists, as often happens during the switch of treatment from antidiabetic tablets to insulin, especially in patients with HbA1c < 9 percent and fasting plasma glucose not exceeding by far the 200 mg/dl (11.1 mmol/L) level. Moreover, the administration of only one insulin injection at bedtime is generally more easily accepted by patients, which is particularly important due to the frequent refusal of patients to accept the receipt of insulin.

Ten units of the insulin Glargine were prescribed at bedtime. It was explained to the patient that the adjustment of the dose would be performed based on the morning fasting glucose levels. The need for body weight loss with the correct diet was once again emphasized. One week later, the measurements of the three last days (in mg/dl [mmol/L]) were as follows:

Breakfast Lunch Dinner

2 hrs 2 hrs 2 hrs

Date Pre after Pre after Pre after Bedtime

20/11 205 244 235

21/11 239 255

22/11 218 236

It is obvious that the insulin dose is insufficient. The mean value of fasting plasma glucose is 220 mg/dl (12.2 mmol/L). The increase in the dose was determined to be six units (see Table 28.5). The following week, the mean value of fasting blood glucose was 192 mg/dl (10.7 mmol/L) and another increase of the dose by six units was recommended. The adjustment was continued (see Table 28.5) and one month later the dose of insulin was stabilized at 28 units. The majority of the measurements, both pre-prandial and post-prandial, were within targets. Three months after the beginning of insulin treatment, the HbA1c was 6.6 percent. The patient's weight remained stable. The same treatment was continued.

CASE STUDY 5

A 63 year old-man has suffered from Type 2 DM for 20 years. He has received isophane insulin (NPH) for three years, 26 units in the morning and 16 units in the evening. His control is moderate (the HbA1c level during the previous year ranged from 7.5 percent to 8.1 percent). One month ago he underwent a coronary artery bypass operation, after a myocardial infarction that he had suffered three months before. After the operation, he continued the same DM treatment. His body weight is normal (weight: 74 kg [163.2 lb], height: 1.72 m [5 ft 7.7 in], BMI: 25kg/m2). Recent laboratory evaluation showed a slightly increased creatinine level (1.5 mg/dl [132.6 mmol/L]). There exists background diabetic retinopathy and diabetic neuropathy. He reports that after the surgery his blood sugar control is worse than ever and he often manifests hyperglycaemic symptoms, despite the fact that he is particularly diligent with his diet. The latest HbA1c is 8.8 percent. He brings a diary with blood sugar measurements for the last three days indicatively shown below (in mg/dl [mmol/L]):

Breakfast

Lunch

Dinner

2 hrs

2 hrs

2 hrs

Date

Pre after

Pre after

Pre

after Bedtime

12/3

255

284

(14.2)

(15.8)

13/3

231

299

(12.8)

(16.6)

14/3

268

331

(14.9)

(18.4)

Strict glycaemic control targets need to be set for this particular patient, since he already manifests both micro- as well as macro-vascular complications while he is still at a relatively young age. The fasting blood glucose level should be < 120 mg/dl (6.7 mmol/L), the post-prandial level < 150-160 mg/dl (8.3-8.9 mmol/L) and the HbA1c < 7 percent. At the same time, because of the recent heart surgery, there is significant, although transient, insulin resistance that is probably responsible for the further decompensation of his blood sugar. Post-prandial measurements are absent from his self-monitoring diary.

In this first approach with the patient, the dose of insulin was increased by four units in the morning and evening and a dietary program was recommended. The importance of the correct self-monitoring schedule, which includes both pre- as well as post-prandial measurements, was explained to him. A follow-up appointment was arranged for 10 days, when the following measurements were supplied (indicatively the last three days are shown [in mg/dl (mmol/L)]:

Breakfast Lunch Dinner

Pre

2 hrs

2 hrs

2 hrs

Date

after

Pre

after

Pre

after Bedtime

24/3

194

324

(10.8)

(18.0)

25/3

200

279

249

(111)

(15.5)

(13.8)

26/3

187

315

299

(10.4)

(17.5)

(16.6)

The blood sugar control remains poor with only a small improvement in the morning fasting glucose levels. It was decided to administer a form of insulin therapy that included a fixed mixture of 30 percent very-rapid-acting-insulin analogue (Aspart) and 70 percent of intermediate-acting insulin analogue with protamine (Novomix), in the morning and in the evening, immediately before the meals. The dose of the evening insulin remained the same (20 units) and the morning insulin was decreased by six units (24 units), which were added at midday, immediately before lunch, in the form of very-rapid-acting insulin analogue. The therapeutic regimen was therefore as follows:

• morning: 26 units of a fixed insulin mixture 30/70 (very-rapid-acting analogue/intermediate-acting analogue);

• midday: 6 units of very-rapid-acting insulin analogue;

• evening: 20 units of fixed insulin mixture 30/70 (very-rapid-acting analogue/intermediate-acting analogue).

A new dietary programme with emphasis on the intake of a sufficient amount of breakfast was recommended. The administration of very-rapid-acting insulin analogue before lunch was considered necessary from the beginning, because the dose of the morning mixture could not be increased any further, since this would lead to hypoglycaemia 2-3 hours after breakfast (due to the simultaneous increase of the very-rapid-acting insulin analogue). It was emphasized to the patient that with this more intensified programme he should measure his blood sugar at least three times daily. A follow-up appointment was arranged for 15 days, when the following measurements were supplied (indicatively the last three days are shown [in mg/dl (mmol/L)]:

Breakfast Lunch Dinner

2 hrs

2 hrs

2 hrs

Date

Pre

after

Pre

after

Pre

after

Bedtime

10/4

153

100

144

178

(8.5)

(5.6)

(8.0)

(9.9)

11/4

140

99

126

151

(7.8)

(5.5)

(7.0)

(8.4)

12/4

163

138

201

(9.1)

(7.7)

(112)

The improvement is impressive. However, the morning values as well as those two hours after dinner remain above target. An increase of the evening insulin by four units was introduced, with the result that, at the following visit, the vast majority of the measurements were within therapeutic targets. Three months later, the HbA1c was 6.6 percent. The same regimen was continued.

In relatively young patients with Type 2 DM, and with the presence of complications, more intensified forms of insulin therapy are required when there exists a serious disturbance in the secretion of insulin. Such a regimen was administered to this patient. Sometimes the administration of intensified regimens of basal-bolus insulin can be required, as in Type 1 DM, but usually this is avoided, because patients with Type 2 DM are usually less motivated and have a limited ability of corresponding to the requirements of these regimens.

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