Look beyond A1C
and uncover more
in clinical trials.1
Are you still relying on A1C and fingerstick testing to assess glycemic safety, efficacy and superiority endpoints in your clinical trials?
Continuous Glucose Monitoring (CGM) technology offers a more complete view of glucose levels and variability than the traditional methods such as fingerstick testing and A1C and gives important clinical data for safety and efficacy in trials. Our innovative technology – combined with leading operational and therapeutic expertise – captures, cleans and analyzes glucose data; optimizing outcomes for you in clinical trials. For the past several years, top diabetes pharmaceutical and biotech companies, clinical research organizations, universities and research hospitals have used CGM to uncover more glycemic data in their drug development as well as real world trials.
|Clinical Trial Need||Solution with iPro™2 CGM|
|Fast Trial Initiation and Completion||Receive more glycemic data in less time2|
|Improved Patient Safety||Identify the frequency, severity and duration of high and low glucose episodes through the day and night3|
|Efficacy & Superiority Validation||Analyze time in range4 and 24 hour glucose control, glycemic variability|
|Patient Compliance||Record up to 288 data points each day without increasing finger sticks|
|Contextual Data||Capture events easily with our mobile app for cause- effect analysis|
iPro™2 CGM use in clinical trials
iPro™2 CGM, when used in clinical research provides investigators with access to customized data analytics and reports. These optimized glycemic data sets can be analyzed more efficiently to assess safety, efficacy and superiority endpoints in the trial in less time.
iPro™2 CGM can uncover important insights for your trials such as:
- Time in range
- High and low glucose episodes
- 24 hour average glucose level
- Glycemic variability (GV) indices
|Study title||What iPro™2 showed in the study|
|Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy2||DRUG EFFICACY & SUPERIORITY
Dulaglutide provided an improved balance between the proportion of values within the near normoglycaemia range and values within the hypoglycaemic range.
|Research centers/ Universities|
|Effects of vildagliptin twice daily vs. sitagliptin once daily on 24-hour acute glucose fluctuations3||DRUG SAFETY & EFFICACY
Vildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled T2D.
|Nutrition/ Microbiome industry|
|Personalized Nutrition by Prediction of Glycemic Responses4||TREATMENT SAFETY & EFFICACY
Personalized diets may successfully modify elevated postprandial blood glucose and its metabolic consequences.
|Clinical research organizations|
|VARIATION study5||TREATMENT SAFETY & EFFICACY
The lowest GV and lowest hypoglycemia were observed in patients using the combination of basal insulin with a GLP-1 RA, supporting the complementary glycemic action of these agents in type 2 diabetes.
Services you need, when you need them.
Training & Education
We offer onsite clinical and technical training in most of the countries across the world. Count on expert support from our therapy consultants and clinical specialists.
Our helpline team is here for you around the clock to answer all your questions Monday through Friday, 5 AM to 5 PM (PST). +1 877-874 -7717, option 3.
We help customers in capturing CGM datasets relevant for the study and deep dive analysis of important CGM parameters.
We offer support in more than 120 countries around the world.
If you have any queries regarding how CGM can be used in your clinical studies, feel free to contact us at:
† At the time of FDA approval of the Guardian Connect System
1. Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Prrukcheewanont P: A pilot study of the continuous glucose monitoring system, Diabetes Care. 2001;24(12):2030−2034 2. Compared to self-monitored blood glucose alone.
2. Jendle J, et al. CGM in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy, Diabetes Obes Metab 2016, 18, 999– 1005. DOI:10.1111/dom.
3. Marfella R et el. Effects of vildagliptin twice daily vs. sitagliptin once daily on 24-hour acute glucose fluctuations. Journal of Diabetes and Its Complications 24 (2010) 79–83
4. Zeevi et al. Personalized Nutrition by Prediction of Glycemic Responses, Cell (2015), http://dx.doi.org/10.1016/j.cell.2015.11.001
5. Bajaj et al. Lowest Glucose Variability and Hypoglycemia Are Observed With the Combination of a GLP-1 Receptor Agonist and Basal Insulin (VARIATION Study) DOI: 10.2337/dc16-1582