We R the Cure

Seeking Cures and Cheating Destiny


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Why Do We Need Type 1 Research? Meet Molly: She Is A Diabetes Advocate Who Almost Became A Diabetes Statistic

I want you to meet Molly. She’s a CDE and clinical nurse trial coordinator at the Center for Diabetes Technology at the University of Virginia School Of Medicine. She’s a type 1 herself who works with the famous Dr. Boris Kovatchev running cutting-edge Artificial Pancreas trials.

UVA Nurse Molly McElwee Malloy

Molly McElwee Malloy

Earlier this year, before you ” met ” Molly — she almost became a statistic. Molly almost died in the early morning hours from a “SH event,” a Severe Hypoglycemic seizure that required EMS intervention and help from a fast-acting spouse. Instead of me trying to retell the story, here’s a link to Molly finally telling her story in her own words in DiabetesMine this August. If you or someone you know lives with Type 1 diabetes, you must read this. Of course, you’ve probably had this happen. My wife has called EMS for me but I have avoided a seizure or trip to the ER.

Here’s a life-and-death detail of Type 1 diabetes:  1 in 20 people, an estimated 2-4 percent and 6 percent in patients younger than 40 years old, will die from severe hypoglycemia.  That’s having a low blood sugar that produces seizures, coma and death. Of the estimated 3 million people in the U.S. with type 1 diabetes, that’s approximately 150,000 people. That’s like wiping out Chattanooga, Tenn. or Rockford, Ill. — wiping them right off the map.

The prevention of a ” hypo event” is a deadly serious issue for T1Ds who strive for tight blood glucose control. That’s the catch-22: The better your control is and the lower your A1cs number is, the better chance you have of avoiding the serious, medical consequences of diabetes ( amputation, heart attack, stokes, and blindness to name a few).

The better your control, however, the higher the likelihood of low-blood sugar events (hypoglycemia).  Wearing Insulin pumps and continuous glucose monitors (CGMs) all serve as valuable tools for T1Ds in the quest for tight control. However, reading Molly’s near-fatal “bedtime story” makes it clear to me: even the best informed and compliant PWDs ( persons with diabetes) will experience severe lows and their insulin pumps will continue to infuse insulin until the patient or an attending EMS tech turns it off manually.

That’s where the Artificial Pancreas and its Safety Supervision System can provide real technology solutions. And that’s why the AP must be available and soon.

Severe Hypoglycemia Event Data

Molly’s Severe Hypoglycemia Event.

The figure ( reprinted with permission from Molly) shows the course of her near-death experience and how  the system would have intervened. Sixty minutes before the ” severe hypo” event the safety system would have alerted the patient and stopped insulin. This alert — think of it as your home’s monitoring system — can send a signal to the patient. And if the patient is sleeping or in what I call a ” diabetes fog — unaware of the pending crash.” it could send an alert to a caregiver or spouse via the system’s remote monitoring capability.

I first met Molly in the summer of 2010 when I enrolled in my first AP clinical trial at UVA. Molly, and her trials colleague Mary, are bright, engaging and positive people. Thanks to Molly and Mary, I’ve enjoyed every minute I’ve spent in the UVA trials — as an in-patient and out-patient. And even though Molly reminds me, gleefully, that her alma mater James Madison beat my alma mater, Virginia Tech, in a football game recently in Blacksburg — I can’t imagine going back to UVA in the future and not seeing her smiling face.

Molly gets ” the need” for more clinical trials and why the Artificial Pancreas is so critical to our long-term health. For all T1Ds who wake up at 2 or 3 AM to treat a low blood sugar and sit in the kitchen wondering what happens the next time our sugar drops below 40,  we know why the AP and better technology must be available in the United States. The safety shutoff is available to insulin pump and CGM wearers NOW — in Great Britain. It’s time for the United States to stop leading from behind and move to the front on diabetes technology and research.

Our lives — and Molly’s life — hang in the balance.


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New Artificial Pancreas Trial: Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin (DP3)

The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.

The study consists of an evaluation of the Artificial Pancreas device system during two 24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C) ratios.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929798

Contacts: Howard C Zisser, MD;

805-682-7640 ext 255

hzisser@sansum.org