The Role of Pen Devices in Making Mealtime Control Achievable

I was recently reviewing the log book of a 72-year-old man on insulin and I noticed that he often had high glucose levels before supper. I said, “Robert, it looks like you are missing lots of lunch doses.” He replied, “Well, it is just too embarrassing taking out a syringe and vial to take insulin at lunch. I go out to eat several times a week with the Retired Old Men Eating Out (ROMEOS).” I realized that I had been seeing him for a year and had failed to evaluate his delivery system. I showed him the newest insulin pen for his rapid-acting insulin.

I was recently reviewing the log book of a 72-year-old man on insulin and I noticed that he often had high glucose levels before supper. I said, “Robert, it looks like you are missing lots of lunch doses.” He replied, “Well, it is just too embarrassing taking out a syringe and vial to take insulin at lunch. I go out to eat several times a week with the Retired Old Men Eating Out (ROMEOS).” I realized that I had been seeing him for a year and had failed to evaluate his delivery system. I showed him the newest insulin pen for his rapid-acting insulin. He held it, played with it, looked up with wonder in his eyes, and said: “This changes everything.” With the pen he was able to carry his insulin easily and nearly always took meal doses. Why was he using a syringe and vial? His physician began treatment with insulin and never thought to offer him a pen.

Pen Use in the US
Insulin delivery in Europe is primarily by pen device, and yet in the US 50–75% of patients are still using a vial and syringe.¹ There are several reasons for this disparity: third-party payment, comfort with devices among healthcare professionals, and an inadequate use of insulin in general. Rubin and Peyrot found that a physician’s presentation of insulin pens was the most powerful predictor of pen use.² A greater than 100-fold likelihood of pen use was found when physicians merely presented the pen as an option. Another predictor of pen use was the patient’s perception that ease of pen use would facilitate selfcare. The benefits of pen delivery devices include:

• accurate dosing;
• faster and easier setting of dose and injection times; and
• increased patient acceptance and adherence.³

Barriers to Starting Insulin
Recent guidelines from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) promote the use of insulin sooner rather than later in patients with type 2 diabetes to achieve goalrange glucose control (<7%), but remain silent on a recommendation for a delivery system.⁴

Even though there is widespread consensus among experts and payers that people with type 2 diabetes should use insulin earlier to achieve tight control, it still remains an elusive goal. In a large patient survey, 28% reported that they were unwilling to start insulin.⁵ Polonsky refers to this as ‘psychological insulin resistance’ (PIR) and suspects that the true prevalence of PIR is much higher. Subjects in the survey reported several reasons for avoiding insulin; most notable was a belief that beginning insulin therapy would indicate they had ‘failed’ in diabetes self-management. Additional patient fears about insulin therapy include:

• taking insulin means my diabetes will become a more serious disease;
• insulin therapy will restrict my life—it will be harder to travel, eat out, etc.;
• the needle will be painful;
• insulin therapy may cause problems with hypoglycemia;
• I am not confident I can handle the demands of insulin therapy; and
• once you start insulin, you can never quit.

The implications for clinical practice are to understand your patient’s beliefs about insulin, and to recognize and address them. Positive beliefs about insulin therapy have been found, including cases of patients initiating insulin therapy and reporting positive changes in their treatment satisfaction in addition to improved glycemic control.⁶ The use of insulin pens is also associated with an increase in satisfactory quality of life compared with traditional insulin syringes.⁷
Why Meal Coverage Is Important
There is widespread agreement that a glycated hemoglobin (HbA_1c) level of 7% or less is appropriate and can prevent microvascular complications.⁸ However, what is not usually discussed with the patient is how he or she feels when his or her glucose exceeds the target range. Most people with diabetes will admit that when their glucose level exceeds 150–160mg/dl they feel tired and sleepy and lack energy. What they may not realize is that they do not have to feel that way. They may have accepted that the hyperglycemia post-meal condition is inevitable. Patients may also have given up on controlling their HbA_1c level. Basal insulin can be titrated to achieve a goal range of fasting glucose so that if that is the only level being monitored, the patient may believe there is nothing more to do. For patients with an HbA_1c >7.3%, post-prandial glycemia accounts for as much as 70% of overall glycemia, and fasting glucose concentrations account for the remaining 30%.⁹ To help the patient achieve the HbA_1c goal of <7% and to feel good throughout the day, post-prandial glucose has to be managed. This becomes more and more complex with a busy changing lifestyle and schedule. As of 2006, about 49% of meals are eaten away from home compared with about 40% in 1970.¹⁰

How to Manage Post-prandial Glucose
Many practitioners fear starting basal–bolus insulin therapy because of the complexity and patient education time required. Bergenstal et al. showed that using a simple ‘adjust to target’ regimen for starting and fine-tuning rapidacting insulin pre-meals was as effective as using a carbohydrate-to-insulin ratio for calculating meal coverage.¹¹ Making meal coverage manageable for patients with type 2 diabetes must include:

• agreeing on goals for control: HbA_1c <7% and post-meal glucose <140–150mg/dl two hours later;
• establishing a goal for fasting glucose and adjusting basal insulin to achieve fasting blood glucose <130mg/dl;
• reviewing usual meals and encouraging patients to eat three meals a day with consistent carbohydrate amounts in breakfasts, lunches, and suppers;
• using the basal dose as a guide for the meal dose and dividing that number into three meal doses: 50% at the largest meal, 33% at the second largest meal, and 17% at the smallest meal;
• starting the patient on an insulin pen that meets his or her needs (disposable versus re-usable, memory, etc.);
• having the patient check glucose fasting and before and after one meal a day—if the post-prandial glucose is outside of the target, the patient will document in his or her log book what he or she had to eat for that meal; and
• using the log book, reviewing meal doses that work and those that do not and helping patients problem-solve meal coverage to either fine-tune standard doses or identify a carbohydrate to insulin coverage factor if that is their choice.

Getting Started on Insulin and Insulin Pens
It is important for healthcare professionals to appreciate that no matter what guidelines say or which algorithms are proposed, people are generally reluctant to start insulin. It is important for all healthcare professionals to be sensitive to the concerns the patient may have about insulin. Many patients have tried for many years to achieve glucose control with combinations of medications and lifestyle and will now feel that they have failed. Patients are most likely to start insulin with a pen when it is presented by their physician as a valuable tool in self-management. It is a key component in the team approach that all members of the team be in agreement about goals for control and strategies to achieve those goals. Some educators feel that they must start patients on a syringe and vial before starting a pen, and then complain that they do not have time to start both. Patients who are offered a pen will usually select pen therapy as their delivery system of choice. Disposable pens come in boxes of five; therefore, even if one malfunctions or is lost, the patient will have spare pens. Teaching the vial and syringe method to the patient as a back-up is like teaching a patient to carry out visual read glucose testing as a back-up to a monitor: we no longer need it!
In many areas, third-party payers penalize patients who choose to use pens. Some plans even charge a co-pay for each vial of insulin or box of pens. This essentially punishes the person with type 2 diabetes and it is up to healthcare providers to advocate reasonable coverage of insulin. It is interesting that a third-party payer would express a desire for patients to use insulin to achieve goals for control, and then make it financially impossible to buy the insulin. Since there is no ‘generic’ insulin on the market, all insulins fall into the second tier or brand-name tier for co-pays. Enlightened payers will make pens equivalent to vials to encourage and empower patients to engage in effective diabetes management strategies.

Another issue often expressed by patients is the fear of weight gain. It is important that we warn patients that starting insulin and lowering glucose levels to within a goal range may lead to weight gain. Assuring them that they can reduce some calories prior to starting the regimen can help them to avoid weight gain while achieving glucose goals. Some additional strategies for starting insulin and achieving meal coverage include:

• presenting the pen first when introducing meal coverage insulin to overcome patient fear of pain, public stigma, and schedule flexibility;
• helping patients to identify the feeling of hyperglycemia and remember the feeling of normal glucose levels;
• encouraging patients to monitor at least one post-prandial glucose level each day at varying times and to keep track of meals that raise glucose levels above target;
• giving simple meal coverage guidelines and helping patients learn to adjust to usual meals and identify some calories that can be reduced that the patient will not miss (e.g. lower-fat milk);
• discussing the risks and management of hypoglycemia; and
• recommending and promoting the pen as valuable tool in the selfmanagement of diabetes.

Mealtime insulin is the key to achieving HbA_1c goals, yet many patients and healthcare professionals are reluctant to start mealtime insulin. Recognize and address the patient’s personal obstacles to using mealtime insulin.¹² Insulin pens make meal-time insulin achievable for both patients and healthcare professionals. It is important to offer pens to all patients as a tool to make insulin delivery easier, more accurate, and private, and to help them reach their glucose goals.■