I do not yet have the iPhone 4. I do, however, have the diabetic’s version of the Hot New Gadget– the Minimed Revel, Medtronic’s latest insulin pump. I am very happy to be able to try out Revel temporarily, on loan from Minimed through the Paradigm Pathway Program, so that I can compare this new model to the model I actually do own– the Minimed Paradigm 522. If I like the Revel, I can choose to upgrade my 522 for $400.
I will be wearing the Revel for a number of weeks to get a better idea of its effect on my day-to-day life and my diabetes management. Here are some of the features that are new to the Revel:
- Predictive alerts: Whereas the Paradigm 522 would alert the user when her glucose levels were above or below certain thresholds, the Revel has predictive alerts that roughly anticipate when the user will pass a set threshold, and alert her a configured number of minutes beforehand with a message like “LOW PREDICTED.”
- Different alert thresholds for different times of the day: The Revel has slightly more flexibility than the Paradigm 522 when it comes to HIGH/LOW thresholds in that the user can set different thresholds according to the time of day.
- More verbose menu and action confirmation screens: The Revel boasts altered wording for some of the menu items that proved unclear to some users of the Paradigm 522 and older models, so, for example, the menu item “PRIME,” which reveals options for restarting the insulin reservoir, has been relabeled “RESERVOIR + SET.” Similarly, there are additional confirmation screens to ensure the user OKs certain procedural actions have been completed (for example, after filling the tubing, the user is asked, “DID YOU SEE DROPS AT END OF TUBING? YES/NO”).
- More graphs: With the Minimed CGM, the Revel can display on the pump glucose trend-line graphs for the last 3, 6, 12, and 24 hours, as opposed to just for the last 3 and 24 hours on the Paradigm 522.
- Missed meal bolus alerts: The Revel can be configured to remind the user to bolus and eat at certain times of the day if the user has not done so since the configured time.
- Lower minimum basal and bolus rates: The Revel can infuse insulin in amounts as low as 0.025 units, whereas the lower limit of the Paradigm 522 was 0.05 units for basal rates and 0.1 units for boluses. This feature is especially helpful for young or small users who are highly insulin-sensitive.
- An expanded insulin-to-carb ratio range: The Revel can be configured to deliver a unit of insulin for as little as 1 gram of carbohydrate or as much as 200 grams of carbohydrate (1:1 – 1:200). The Paradigm 522 was limited to a range of 1:3 – 1:150. This expanded range provides more flexibility especially for those users who are highly insulin-resistant.
For some additional background and to give me a better idea of whether I should just wait for the next round of upgrades, I turned to Samantha Katz, winner of the 2009 DiabetesMine Design Challenge and now Global Product Manager at Medtronic Minimed, with a few questions. Ultimately, I imagine my $400 decision will be based on utility, look, and feel, but it is helpful to understand better where the Revel comes from and what it is trying to be:
What has changed about the manner in which the Bolus Wizard calculates recommended boluses? Has anything changed in its algorithms?
Medtronic’s focus has always been on safety, and as such the Bolus Wizard® continues to safely calculate boluses by taking into account both active food and correction bolus insulin. Nothing has changed about the manner in which the Bolus Wizard® calculates recommended boluses.
What, if anything, has changed about the manner in which the Continuous Glucose Monitor operates? Has anything changed in its algorithms? Would a single sensor give me identical estimated glucose readings on a 522 and a Revel, all other things being equal?
The Minimed Paradigm® Revel™ Insulin Pump includes a new feature called predictive alerts that the previous model did not have. The predictive alerts algorithm is sophisticated and includes a rate of change calculation and real-time sensor glucose values, providing patients with advance warning of reaching their high or low glucose threshold. In January 2010, a study was published in the Journal of Diabetes Science and Technology, which demonstrated that the Revel™ with predictive alerts improved hypoglycemic detection by up to 36% more than use of low glucose threshold alone.
Has there been any demographic-based comparisons of Revel performance? That is, have you looked at the Revel’s performance versus no pump or versus the 522 by age group, education, ethnic group, etc.?
There have not been any studies of this nature completed to date.
Many of the Revel’s new features seem targeted specifically toward type 2 diabetics– much higher insulin-to-carb-ratios and insulin markers for non-pump insulin events, for example. Is the Revel being marketed more heavily to type 2 patients and their doctors than other pumps in the past have? Do you have any numbers as to what percentage of the pumps are issued to type 1 versus type 2 diabetics? How does that compare to the sales of the previous models?
The new features of the Revel™ offer greater flexibility for all types of patients. Insulin sensitive patients will benefit from higher insulin to carb ratios (now as high as 1:200) and the ability to program their basal and bolus amounts in 0.025 unit increments. In fact, the Revel™ is the only pump available with such bolus precision. Type 2s and insulin resistant patients will benefit from the lower insulin to carb ratios (now as low as 1:1) and 300 unit reservoir in the larger Revel™ model. Certainly the Revel™ is more appealing to type 2 patients, and we hope to get as many insulin-taking type 2′s on a pump as possible. Generally speaking, pump therapy is being used more and more by type 2 patients.
Where was the Revel designed? How many people are involved in the production process, from cradle to grave? Where are the components built? And assembled?
The Revel™ was designed and developed in our headquarters in CA, and it is primarily manufactured in our Puerto Rico facility.
How does product development in America differ from product development in Europe for Minimed?
All product development is done in our headquarters in CA, but we customize the product for global markets based on market, legal, and regulatory needs.
How has the Veo, available only in Europe, differ from the Revel? How has the Veo been performing with patients in Europe?
The Veo™ is very similar to the Revel™. Key differentiators are the low glucose suspend feature, the world’s first step towards automation, as well as a 75 unit maximum bolus setting. It has been well received. We hope to gain FDA approval for these features in the US in the future.
What’s next in the pipeline from Minimed in terms of pumps and CGMs in the US? When will the next iteration be available?
Achieving optimal clinical outcomes and ensuring safety continues to be our primary focus. In addition, our next generation pumps will be more user friendly and have an expanded set of features making the pump more convenient and a better lifestyle fit. As we’ve disclosed in the past, we are also developing a patch insulin delivery system. As for CGM, our next sensors will have greater accuracy and a more comfortable insertion process.
If you’d like to share your thoughts on Revel, please leave them in the comments below.
Karmel Allison is science editor of ASweetLife. She writes the blog Where is My Robot Pancreas?.