Healing and Hope

A Newsletter of the Diabetes Institutes Foundation

March 2006

A NOTE FROM THE EXECUTIVE DIRECTOR

Dear Reader,

This month spring arrives, and we're pleased to share with you the latest in cure research development at the Strelitz Diabetes Institutes. Many of you have inquired about results of last year’s clinical trials, what's new in the Institutes' laboratories, and what's on the horizon. Research progress is exciting!

In this newsletter, you'll also learn about the SDI's Insulin Pump Users support group. The SDI has one of the largest support groups in the United States helping people use their insulin pumps most effectively.

Blood glucose management is a real challenge for many people. Find out about managing yours from dietitian Phyllis Woodson's article, "10 Reasons Why Your Blood Glucose (BG) May Not Be As Well-Controlled As You Would Like."

With the weather turning warmer, we all want to think about enjoying time outdoors. Upcoming are two wonderful spring time Foundation events, the 8th Annual Mike Cavish Golf Tournament & Dinner Party on April 24th and the 12th Annual Cookout for the Cure on May 25th. Looking forward to the summer, the popular Lee Mazzilli Celebrity Golf Classic will take place on July 31st. Mark your calendars. We hope you will join us for the fun and the festivities.

Best,
Anna Goldenberg
Executive Director
Diabetes Institutes Foundation

FOUNDATION NEWS

Ready, Set, Golf!

Sponsorship opportunities are still available for the 8th Annual Mike Cavish Golf Tournament & Dinner Party, at Portsmouth's Bide A Wee Golf Course on Monday, April 24th.

For more information,visit our website.

MEDICAL NEWS

Update on Islet Regeneration Research SPIRIT Team Pushing Forward With Positive Results From Phase 2 Trials

With positive results from last years Phase 2 trials and exciting new findings in its basic science laboratories, the Strelitz Diabetes Institutes’ SPIRIT team continues to set an innovative course for development of the INGAP gene toward a cure for diabetes.

Dr. Aaron I. Vinik’s research team is collaboratively working with international scientists and the biotech industry to swiftly develop regeneration research on all levels.

In June 2005, Dr. Robert Ratner of Medstar in Washington DC reported on the findings of the INGAP Phase 2 clinical trials. INGAP was found to be absolutely safe given in large amounts for a period of three months, and in terms of efficacy, changes were noted in both Type 1 and Type 2 diabetes.

In people with Type 2 diabetes, there was a decrease in A1cs by 0.6%. The Food and Drug Administration considers this sufficient for its approval of a product for lowering blood glucose in the treatment of diabetes. There was also an increase in postprandial (after eating) blood glucose.

Both people with Type 1 and Type 2 diabetes had an increase in C-peptide levels indicating that new islets were being formed.

Clinical trial participants received INGAP treatment for 90 days and were followed for 120 days. Recent re-analysis of the Phase 2 findings indicates that results persisted for 30 days after the trials were completed. This is very important because it shows that INGAP treatment changed the biology of diabetes in trial participants.

Dr. Ratner commented in his report, "In these Phase 2 trials for safety of INGAP, clear trends for efficacy have been found and suggest that with appropriate dosage, site of administration and duration of therapy, this approach holds clear promise to evolve into a new therapeutic approach to Type 1 and Type 2 diabetes."

In light of these findings, SPIRIT (Stimulation of Pancreatic Islets in Type 1 and Type 2 Diabetes) scientists at the SDI continue their investigations to find out the optimal route for INGAP administration, the optimal dosage and way to administer the gene, how to protect newly formed islets (Type 1), and how to sensitize the body to newly created insulin (Type 2).

Last summer, the SPIRIT team achieved a significant milestone when they used transgenic animals to show that the production of pancreatic islet mass is dependent on INGAP expression in the acinar tissues of the pancreas.

As basic scientists continue their research, Kinexum Metabolics, Inc. has sublicensed INGAP Peptide from GMP Companies for further clinical trials.

Dr. G. Alexander Fleming, President and CEO of Kinexum, was formerly the Food and Drug Administration’s senior endocrinologist and clinical group leader for the evaluation and regulation of diabetes and metabolic therapies.

Dr. Fleming believes that INGAP Peptide "offers excellent prospects for a breakthrough therapy and the achievement of a major scientific milestone."

For people struggling with diabetes "INGAP Peptide holds great promise for improving the health and quality of life of people with insulin-requiring diabetes particularly those with Type 1. (It) could provide substantial or major value for all people with Type 1 and some insulin dependent people with Type 2 by restoring the ability to secrete insulin."

He goes on to say, "INGAP Peptide probably does not affect the underlying immunologic cause of Type 1, but it may by itself overcome the ongoing immune destruction of insulin secreting cells. As safe and effective immunotherapies become available, they are likely to work synergistically with INGAP Peptide to return perhaps close to normal insulin secretion."

Clinical trials are to continue in the near future.

In anticipation of the issues that may be encountered, SDI scientists are working in animal models to investigate the underlying physiological mechanism by which INGAP exerts its biological effects. They are looking at the robustness and durability of the response to INGAP, reproducibility of the response, long-term safety in high doses, alternate routes and frequency of delivery and the possibility of delivering INGAP with a pump.

POPULAR SDI PUMP GROUP OFFERS SUPPORT

In the late ‘70s the insulin pump opened up a whole new world for Type 1 diabetes, allowing them much more flexibility in what and when they ate and better blood sugar control. Its major advantage was that it allowed people with diabetes to match their insulin to their lifestyle, as opposed to injections determining activities.

Insulin pumps mimic the body’s normal release of insulin, by dispensing a preprogrammed, continuous dosage tube via a catheter. Studies have shown that the more closely someone monitors his or her blood glucose levels , the smaller the chances of developing life spoiling complications, such as eye, kidney and nerve disease.

Because going from insulin injections to the pump is a bit like graduating from high school to college on the diabetes management scale, it’s not recommended for anyone who is not already accustomed to carefully monitoring their diet or who take fewer than 4 insulin shots a day. While it does eliminate the need for insulin shots and allows much more flexibility, the pump is not a replacement pancreas, i.e. it cannot read blood glucose levels and adjust insulin doses accordingly.

"You have to have an understanding of diabetes, be motivated and know what you expect to get out of it," says Jean O’Brian, RN, CDE, who heads the SDI Insulin Pump program. "It’s the most technical way to manage your diabetes. But if people feel empowered, they always tend to do better."

Over a decade ago, O’Brian breathed new life into a monthly support group aimed at pump users, their families and anyone interested in learning more. When she first began working at SDI, insulin pump technology was still relatively new and users relatively scarce. But now the Institutes' pump users number close to 1,000, and thanks to O'Brian's efforts, her support group has steadily grown.

Participants range in age from their mid teens to late eighties. O’Brian always recommends that younger patients, who tend to be more body- conscious and have more questions about ease of wearing, come to a group meeting, which often includes speakers. As with most technologies, over time pumps have shrunk to around the size of a beeper and are easily hooked onto a belt, carried in a pocket or tucked under clothing. "I’ll demo on a pillow or actually let them experiment with an infusion set just to get the idea of it," she says. "I tell everybody that the actual wearing of the pump is never a deterrent for people."

O’Brian enjoys the group and the good it does. "Some support groups can be kind of a downer. You might only hear about the worst side of things. Ours is encouraging, it’s uplifting and fun group." Education on how to use this delivery system is essential to patient success. "If you just turn it over to them and show them how to push buttons, they don’t do very well. But if you really educate them, I’ve seen patients improve 100%. And that’s very satisfying."

Cartographer and longtime SDI patient Blake Hathaway, who has had diabetes since she was six and a half, began using an insulin pump eight years ago and gives it an enthusiastic endorsement. "It gives me the freedom to get up and go and has been really great for controlling my diabetes," she says.

Meetings are held on the third Tuesday evening of the month at 7 pm in the Cosmopolitan Education Room at the Strelitz Diabetes Institutes, 855 W. Brambleton Avenue, Norfolk. If you are interested in finding out more about the program, please call Jean O’Brian at (757) 446-5909.

NUTRITION TOPICS

Top 10 Reasons Why Your Blood Glucose (BG) May Not Be As Well-Controlled As You Would Like: Advanced BG Pattern Management With Carb Counting

Phyllis Woodson, MS, RD, CDE, Clinical Dietitian

1. Incorrectly estimating or measuring carbs (including eating out, recipes).

2. Eating high fat foods affecting the digestion of carbs or the action of insulin.

3. Not eating a "balance" of foods at meals (protein, starch, vegetable).

4. Eating certain "trigger" foods that elevate YOUR BG (usually certain starches, fruits, or combination foods).

5. Poor timing of meals - eating too often or not often enough.

6. Not counting carb grams in "vegetables" (salads, broccoli, etc).

7. Not considering the effects of stress, sickness, or exercise/lack of exercise on BG.

8. Not monitoring your BG often enough to identify patterns.

9. Incorrect Food Factor or BG Correction Factor. Your Food Factor may vary from meal to meal. For example, you may be taking 1 u Novolog or Humalog per 15 grams of carbs. Incorrect BG Correction Factor (eg, you may be taking 1 u Novolog or Humalog per every 50 points your BG is elevated over 150). Either of these factors may need to be changed from time to time.

10. Incorrectly set basal rates if on the "insulin pump". The basal rate is the amount of insulin infused from the pump over a 24 hr period. The average person may have 2-4 rates a day. Problems with the infusion line or site could cause erratic BG.

Bon Appetit!

Yours in good health,
Phyllis Woodson, MS, RD, CDE
Dietitian