West Los Angeles

Seniors with Type 1 Diabetes - Results of Two CGM Trials

As diabetes care has improved, we are seeing our type 1 diabetes patients (T1D) living longer into their senior years. As this happens, we know that older individuals also have an increased risk of experiencing low glucose levels or hypoglycemia, this could be caused by being less sensitive to low glucose levels or having other medical conditions.

We know that using a continuous glucose monitor (CGM) has the potential of reducing these low glucose events, but can this technology-based solution work in seniors? We have recently completed two trials with our senior T1D patients to find the answer.

WISDM at 6 Months

T1D patients 60 and older from the USC Westside Center for Diabetes were added to a total of 203 participants from 17 sites in the T1D Exchange Clinical Network for a one-year trial. Half of the participants were provided with a Dexcom G5 CGM and the remainder continued to manage their diabetes with a blood glucose meter. A1C at the start of the trial needed to be less than 10, no one used a CGM before the trial and there was an approximate mix of insulin delivery by either injections or insulin pump. At the end of 6 months all the participants were supplied with a Dexcom G5 to use until their participation reached 12 months.

The last of our 12 participants completed the trial in May and the 6-month results were presented at the recent 79th ADA Scientific Sessions in San Francisco and the full trial data is being collected and analyzed.

Most trial participants were able to use the CGM and some needed more help than others on inserting the sensor and monitoring their glucose data on a receiver or smart phone. One barrier was the physical dexterity required to insert the G5 sensor, we were hoping to reduce that issue by upgrading to the easier to insert G6 when it became available, but production delays interrupted the availability to study participants - and Medicare patients.

Extra support was also required to make a connection to CGM data for some participants, although there were also advanced users including one participant with a new phone that required using and open-source app to see his data.

The results showed improvements in the CGM group on multiple measures compared to the group who used a meter to control glucose levels. The CGM had 9% more time-in-range (between 70-180 mg/dl) lower average glucose levels with less variability. There were fewer low and high glucose readings and a small 0.3% reduction in A1C.

The six-month data showed benefits in all areas of glucose control and the continuation of the trial will determine if the improvements continue for the full year in the CGM group and whether the group who used a meter in the initial six-months will have a similar improvement when they have access to a Dexcom system.

CGM-Tele Monitoring in Older Adults with T1D:  Results of a Pilot Study

Thanks to our generous donors, we were able to conduct a 14-week pilot study in a group of T1D seniors 64 and older using a Dexcom G5 or G6 to see if an automated alert system was possible and would help to reduce episodes of hypoglycemia. We worked with our friends at Tidepool to develop an automated system that would trigger an alert if glucose levels were either below 54 mg/dl for 15 minutes, between 54-70 mg/dl for over 2 hours, or if there was over 4 hours without a signal. If an alert was triggered, a diabetes educator would review the data each morning in either Tidepool or Clarity and if confirmed he would reach out to the participant to provide education or refer to a physician for follow-up.

The outreach would start with a phone call, text message or email and progress to an in-person visit when needed.  Most of the alert triggers were for either connection issues with an iPhone or transmitting the data to Tidepool. We learned that it was better to connect the Dexcom Clarity account to Tidepool than using the Tidepool app. This was because some seniors use their phone similar to a landline phone — only to make and receive calls and data only transfers to the Tidepool app when the phone is awake. The Tidepool app worked for very active iPhone users and it is useful for adding messages to the CGM data.

Instead of the real-time monitoring available using the Share/Follow feature in the Dexcom app, the outreach contacts reviewed what happened the previous day. The day after contact allowed for an easy recall of the low event and most of the issues were the common T1D issues of eating out and mis-judging the insulin dose or trying to correct a stubborn high. There was even outreach with a participant traveling in multiple European countries where lows were triggered by more activity while on vacation.

There were a couple of in-person meetings where pump data was added to the Dexcom tracings and we reviewed advanced pump techniques to prevent lows, but no insulin dose adjustments were required and there was no reduction in hypoglycemia in the trial.

This short proof of concept trial did show that it is possible to create an automated alert system and provide education out-reach while the low glucose event was still easy to recall. The results were presented at the 79th ADA Scientific Sessions and will be used to apply for a grant to conduct a longer trial to more fully determine the clinical impact.

REAL-T

In the late summer/early fall we will be recruiting for a study of young adult type 1 diabetes patients between the ages of 18-30 with a A1C of 7.5% or higher. This is a 12-month telehealth behavioral intervention that will be performed by USC occupational therapists. The initial meeting will take place at our research office and the remaining contacts will be with either videoconferences or text messaging. More details will be available later, if you are interested contact Mark Harmel at mark.harmel@med.usc.edu or 310-546-6509.

 

East Los Angeles

D2d Study

The Roybal Center was one of the 22 sites selected by the National Institutes of Health for the largest study specifically designed to determine whether taking vitamin D supplements can reduce the risk of developing type 2 diabetes. The results of this D2d Study are critically important for the 86 million people with prediabetes (an early form of type 2 diabetes) in the US and for the costs related to individuals and the healthcare system.

Earlier population studies indicated that people who had lower levels of vitamin D were more likely to develop type 2 diabetes, but it wasn't know if taking a daily pill of vitamin D would prevent diabetes development.

A total of 2,423 participants with prediabetes were randomized to either take 4,000 units of vitamin D or an identical looking pill (placebo group) without the added supplement. The study participants were followed from 2-5 years to see if there was a difference in rate of progression from prediabetes to type 2 diabetes.

The results were recently announced at the 79th ADA Scientific Sessions and unfortunately there was no benefit for the group who received the vitamin D except for those had very low vitamin D levels (less than 12) at baseline.  There was no harm in taking the vitamin D, however, just not benefit overall.

Fortunately, there is still a proven intervention that was verified in another large Diabetes Prevention Program trial that a structured lifestyle change program can cut their risk of developing type 2 diabetes by 58%. And for people over 60 the reduction is even better, there is a 71% in this group. You can take a simple online test to see if you are at risk for developing type 2 diabetes and you can find either a in-person or online Diabetes Prevention Program to join. Many commercial insurance plans, and employers will cover the cost of the either delivery of the prevention program and Medicare reimburses for the in-person program.

Simple Guide for Continuous Glucose Monitors

Thanks to the support by the Leona M. and Harry B. Helmsley Charitable Trust we have been able to continue to expand our simple English and Spanish type 1 diabetes guides that are geared to a 5th grade reading level. In addition to the completed guides on improving management, insulin pen, pumps. We are updating the current guides for pediatric patients and their parents and made progress on the newest guide on using continuous glucose monitors. We expect that the newest guide will be ready by early 2020.

MOBILE CGM Study in People with Type 2 Diabetes

Great progress is being made in recruiting patients in the study to determine if a Dexcom CGM would provide benefits in either glucose control or quality of life for participant with type 2 diabetes who are using long-acting, but not mealtime insulin. We have screened 43 participants and there are 25 currently active in the trial. This a 14-month trial and our East Los Angeles location allows us to recruit from a study population that is representative of many people with type 2 diabetes who often don't have access to the latest diabetes technology.

 

Study Updates