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RESEARCH SUPPORTS MDI AND INSULIN PUMP THERAPY

      There have been a lot of research studies in the fields of MDI and insulin pump therapy, and many of them have shown that there are potential benefits in diabetes care. Here are some studies that have helped us better understand how to manage diabetes and how MDI and particularly insulin pump therapy can be a useful tool.

      The Diabetes Control and Complications Trial (DCCT)

      Before the mid-1990s, someone with type 1 diabetes would take one (maybe two or, rarely, three) insulin injections per day. Back then, regular, NPH, lente, and ultralente insulins were in use. Except for NPH and regular, these other insulin preparations are not available today. Insulin doses weren’t adjusted from one day to the next, which meant that people had to follow a strict eating plan and physical activity regimen. That meant you couldn’t skip breakfast, you couldn’t delay having lunch, and if you routinely had a snack in the afternoon, you had to eat one even if you weren’t hungry! Although you might have taken fewer shots, the trade-off in having a fixed diet and activity pattern wasn’t worth it—and more importantly, this regimen led to inadequate diabetes control.

      The Diabetes Control and Complications Trial (known as the DCCT) was a nine-year study. When the results were reported in 1993, the concept of how diabetes should be managed was changed forever. The investigators proved that tighter glucose control using MDI (three or more shots per day) or insulin pump therapy was better than conventional therapy at lowering A1C and reducing the risks of developing diabetes complications.

      The DCCT conclusively showed that blood glucose control matters. Although the youngest participants in the DCCT were 13 years old when they entered the study, the overall results of the DCCT have been generalized to all of type 1 diabetes: effective blood glucose control is the most effective way to reduce the long-term complications of diabetes.

      Over 1,400 people with type 1 diabetes took part in the study. They were divided among two groups: one for intensive management and the other for conventional therapy (the way diabetes used to be managed). The intensive group used MDI (three or more shots per day) or an insulin pump. This group also received a great deal of support from the study teams. At the end of the DCCT, the people who used MDI had an average A1C level of 7.4%. Those receiving conventional therapy took one or two shots a day, and did not have blood glucose targets or a lot of support from the study teams. Their average A1C levels were 9.1%. Nine years later, those in the intensive group had fewer severe eye, kidney, and nerve problems than those in the conventional group. This was a stunning discovery. However, the other lesson from the DCCT was that lowering A1C levels increases the risk of hypoglycemia.

      Epidemiology of Diabetes Interventions and Complications (EDIC)

      After the DCCT concluded in 1993, a follow-up study began, and it is still running today. The study is called Epidemiology of Diabetes Interventions and Complications (EDIC), and almost all of the DCCT participants entered into it (but they did return to their previous health care teams, not the study teams). By 2009, those who had been in the intensive group had lower rates of eye disease, kidney disease, and cardiovascular disease when compared with those in the conventional group. Although the people in the intensive group did see an increase in their average A1C levels over this period, there was still convincing evidence that intensive management and improved A1C levels provide noticeable health benefits, even if the therapy was provided years before. That is why considering an insulin pump to manage your diabetes makes sense.

      LESSONS FROM DCCT AND EDIC

      After 30 years of diabetes, fewer than 1% of participants in the intensive group had become blind, required kidney replacement, or had an amputation because of diabetes.

      Other Studies and Guidelines

      Many studies have evaluated insulin pump therapy. Although none have had the scientific rigor of the DCCT, overall they show that insulin pump therapy decreases A1C, and now it has also been shown to reduce rates of hypoglycemia. These studies have been done across age groups, for different conditions (such as pregnancy or severe hypoglycemia), and in many places around the globe. There have been 11 studies that compared insulin pumps to MDI, and across all of them, A1C was approximately 0.5% lower in those using insulin pumps. Regardless of who is using the insulin pump, the studies have shown an overwhelmingly positive benefit.

      Studies with Sensors and Sensor-Augmented Pumps

      A CGM is a device that can give information in real time to help with diabetes management decisions. With some devices, the pump and the CGM work together in a single system. The expanded availability and use of CGMs can be partially credited to clinical research into this new device. Some of the studies looked at the use of insulin pump therapy integrated with a CGM. This type of therapy is often called sensor-augmented pump therapy, or SAPT. Other studies looked at the benefits of individuals using a CGM either with an insulin pump or with MDI.

      The Juvenile Diabetes Research Foundation (JDRF) sponsored one of the largest studies ever done on CGMs. The study included 322 adults and children who were receiving intensive therapy for type 1 diabetes (either with an insulin pump or MDI). After six months, adults showed improved blood glucose control. A subset of children and adults whose A1C values were less than 7.0% at the beginning of the study was also analyzed. In this group of individuals, low blood glucose (hypoglycemia) was less frequent, time spent out of the target blood glucose range was shorter, and average A1C levels were still excellent. The benefits of CGM go beyond just the clinical benefits and improved glucose control: the adults and parents of children who used CGM were also pleased with this method of treatment.

      In 2010, the results of the STAR 3 study were published in the New England Journal of Medicine. The STAR 3 study is the largest study of its kind, and it examined the benefits of SAPT in people with type 1 diabetes comparing it against MDI. The study demonstrated that in both children and adults with inadequately controlled type 1 diabetes, SAPT improved A1C levels. A1C levels were 0.6% lower than those in the MDI group. Also, a greater number of individuals reached their A1C target levels.

      Once the STAR 3 study was completed, the patients receiving MDI in the first year of the study were placed on SAPT for six months. They were compared with the people who received SAPT during the first year of the study and who continued on SAPT for the same six-month period. There was a significant

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