Impact of a Clinical Pharmacist Regarding Correction of Insulin Use Before Possible Conversion from Traditional Insulin to U-500 Regular Insulin in a Patient With Uncontrolled Type 2 Diabetes

A wheelchair-bound, 64-year-old white man presented to the pharmacist-managed metabolic clinic with a history of uncontrolled type 2 diabetes. The patient was referred by his primary care provider (PCP) for diabetes management and insulin adjustment, with the intention of eventually converting the patient from a traditional insulin therapy regimen to concentrated U-500 regular insulin.

The patient had a history of metformin and glipizide combination therapy and was converted to a regimen of glargine and aspart when his oral medication regimen failed to control his diabetes. Glipizide therapy was discontinued when insulin was initiated in 2010, and metformin was discontinued in 2011 because of declining renal function.

The patient's weight was 335.9 lb; his BMI was calculated to be 48.2 kg/m². He reported currently smoking a pack of cigarettes per day with no intention of enrolling in a cessation program. He reported no alcohol or illicit drug use. During the intake interview, he reported a fair diet, with intake of simple carbohydrates being a prominent dietary source of glucose. He reported limited physical activity aside from wheelchair use. The patient also reported a positive family history for type 2 diabetes in his mother. His diagnosis list is shown in Table 1.

The patient's medication profile, as originally prescribed, is provided in Table 2. He reported poor adherence to his insulin regimen but close adherence to his oral medication regimen, aided by the use of a daily/weekly pillbox. When pressed for details about his insulin failure, he reported that he simply forgot to use both his basal and bolus insulin and did not feel safe using them past the recommended administration times. He also reported that, when he did take his glargine, it was not at the prescribed dose, but rather was a dose of ~ 110 units (drawing past the 100-unit syringe mark to what he thought would be 110 units).

Laboratory tests and vital signs were collected and are reported in Table 3. Of note, the patient's A1C was 10.0%, his fasting blood glucose was 143 mg/dl, and his serum creatinine was 2.7 mg/dl. A lipid panel revealed a total cholesterol level of 191 mg/dl, with LDL cholesterol of 103 mg/dl, HDL of 33 mg/dl, and triglycerides of 444 mg/dl.

At the initial appointment, using the motivational interviewing technique, the pharmacist and patient discussed the current insulin regimen and the patient's failure to follow it. The patient was not following his prescribed doses of glargine (110 units, twice daily) and aspart (40 units before meals), and the amounts he was taking drastically altered what his PCP had considered to be his total insulin load. The patient correctly recited the prescribed doses but expanded on his reasons for poor adherence. He declined to take more than a single injection per dose because, he said, he “didn't want to poke myself twice.” He also repeated his concern about taking insulin beyond the planned administration time when he forgot shots. Although he was aware of the possible detrimental effects of his uncontrolled diabetes, the patient was apathetic about his insulin use, providing no further reasons for his lack of adherence.

When questioned further about complications of diabetes, he said he was experiencing progression of both peripheral neuropathy and retinopathy but did not correlate this to his high blood glucose levels. Laboratory tests indicated progression of chronic kidney disease, but again the patient did not express concern about this.

The patient's spouse, in attendance at the interview, stated that the patient often became argumentative when encouraged to take his aspart before meals, accusing his spouse of nagging and harassing him. Being wheelchair-bound, the patient discussed his feelings of helplessness in his inability to exercise as he did in his younger years. When questioned about stricter dietary control, however, he again could offer no explanations for poor choices other than that he ate what made him feel better.

The patient and pharmacist agreed that the patient would be referred to the nutrition department for a dietetics consultation and referred back to his PCP for depression management because this component of care was beyond the pharmacist's scope of practice.

The pharmacist and patient then had a candid discussion in which the pharmacist said he did not believe the patient was a good candidate for U-500 insulin use. The patient understood the adherence concerns and also understood that a possible future change to U-500 would be directly tied to successful adherence and improvement in diabetes outcomes. They developed a plan to closely monitor the patient's clinical progress as he took steps to improve his adherence. They agreed on an initial goal A1C of < 9.0% and a long-term A1C goal of < 8.0% in accordance with the Veterans Affairs (VA)/Department of Defense (DoD) guidelines regarding patients with moderate to severe complications of diabetes.

The patient's insulin regimen was altered to take into account his desire to only administer one injection per dose. The new regimen consisted of glargine, 100 units twice daily, and aspart, 50 units before meals. This change was also instituted to balance the bolus insulin to ~ 50% of the basal insulin load. (The patient reported only eating twice daily.) The patient understood the new regimen and agreed to the change to learn his true A1C outcomes when he adhered to his plan of care.

Follow-up occurred through phone contact every 2 weeks to provide blood glucose readings and report any hyper- or hypoglycemic episodes. Through these phone appointments, the pharmacist adjusted the insulin regimen to address elevations or decreases in blood glucose levels.

This plan was executed in a 12-week period, with repeated laboratory tests for basic chemistry and A1C. At the end of 12 weeks, the patient's A1C was 7.1%, and his serum creatinine was 2.9 mg/dl (Table 3). The patient reported improvement in the noticeable signs and symptoms of his peripheral neuropathy and noted that he did not feel that he was having the visual impairments previously disclosed (and likely caused by chronic hyperglycemia). The patient's insulin regimen at the end of 12 weeks consisted of glargine, 80 units in the morning and 50 units in the evening, and aspart, 30 units with a corrective scale before meals (Table 4).

1. What is the impact of clinical pharmacists in the management of diabetes in the primary care setting?

2. What type of follow-up and referral services can aid in the management of patients with grossly uncontrolled diabetes?

3. What is the impact on insulin dosing and medication management in patients closely followed by a pharmacy service?

The VA/DoD recently instituted programs incorporating clinical pharmacy specialists as primary care practitioners responsible for managing patients with metabolic diseases (e.g., diabetes, hypertension, and dyslipidemia). These programs, although still being evaluated, are seen at the local level as extremely valuable. Several trials have been performed to assess the impact of a clinical pharmacist on the management of diabetes, from monitoring and educational programs to direct medication interventions and adjustments.^1–3  These studies have justified clinical pharmacist involvement in direct patient care for chronic disease state management.

As illustrated in this case study, one of the greatest impacts of the VA/DoD program has been the ability to closely and consistently follow up with patients who have uncontrolled diabetes. In this case, the pharmacist was able to help the patient reduce his A1C by 2.9% and reduce his true total daily dose of insulin while also meeting the health care system's desired A1C goal.

Many patients do not have the consistent contact with their PCP that is necessary to ensure good adherence to and outcomes of an insulin regimen. Patients requiring frequent contact and adjustment of their insulin regimen are outstanding candidates for management within this type of clinical pharmacy program. As outlined in this case, the scope of this clinical pharmacy practice allows pharmacists to monitor disease state management and laboratory values, adjust and follow up on therapy regimens, and monitor and report back to PCPs on the progression of complications.

The case described here is considered a success within the VA/DoD setting by virtue of the patient's goal achievement. The patient also reported feeling much more confident in his diabetes management and pleased with the outcomes of this program compared to his previous standard of care. Expansion of this type of service beyond the VA/DoD setting and into private primary care practices and health care systems will allow for further successes of this nature, continued opportunity for expansion of the clinical pharmacist role, and improvement in diabetes management practices.

• Patients referred for U-500 concentrated insulin therapy must have a thorough evaluation and review of their true insulin utilization before dose conversion.

• Management of an insulin regimen through nontraditional services such as a clinical pharmacy program may lead to lower dosing of insulins resulting from improved patient adherence and close follow-up.

• Thoroughly interviewing patients is necessary to ascertain their true treatment plan; involving patients in developing their future treatment plan may result in better adherence and a concordant relationship between patients and the care team.

• Integrating the services of a clinical pharmacist in the management of chronic disease states such as diabetes can increase patient contact and shorten follow-up periods, leading to improvement of measurable patient outcomes and clinical goals.