Patients who use insulin frequently experience a substantial amount of glycemic variability. On any given day, insulin users can experience extreme high glucose and extreme low glucose levels. Even if the variations aren’t extreme, the ups and downs and the wide variations in glucose levels take their toll on the lives of patients, often impacting mood, the ability to function, think clearly and exercise regularly.
The current “gold standard” for measuring diabetes control, Hb A1C, does not reflect the glycemic variability that impacts the ability of patients to live a healthy, functioning life. Patients need a better measure, which more accurately reflects the impact of glycemic changes on their ability to function and their quality of life.
This study protocol is aimed at creating a study that will enable the development of the impact of glycemic variability on patients’ daily experience of their disease. The original draft was developed in partnership with the American Diabetes Association, which is working with VitalCrowd founder Anna McCollister-Slipp to get support for the new study from both the Food and Drug Administration and the Patient Centered Outcomes Institute.
Help us make the study the best study possible! Contribute your insights into the design of the study and the tools that should be used.
JMilo at 2:57pm on December 15th, 2015
I've tried to plot my variability (with the great help of my husband, a design engineer which experience in statistical mapping) using data from my cgm. It will help to also have the input from insulin dosing (from pump or data log of shots) as well as input regarding food and exercise (type and intensity and duration). But even just plotting from CGM will show variability. If there were a way to also input from patient regarding assessment of quality of life, even on a once a day basis might show something.