A healthcare professional showing a CareLink report to the patient.

CONTINUOUS GLUCOSE MONITORING (CGM) IN CLINICAL STUDIES

CGM USE IN CLINICAL STUDIES

Are you still only relying on A1C and fingerstick testing to assess glycemic safety, efficacy, and superiority endpoints in your clinical studies?

Our innovative technology — combined with leading operational and therapeutic expertise — captures and analyzes glucose data, so that therapy and clinical outcomes can be optimized based on that data. 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.

LOOK BEYOND A1C AND UNCOVER MORE IN CLINICAL STUDIES

Clinical Trial Need Solution with iPro™2 CGM
Fast Trial Initiation and Completion Receive more glycemic data in less time1
Patient Safety Identify the frequency, severity, and duration of high and low glucose episodes through the day and night2 so that appropriate adjustments can be made
Drug/Therapy Efficacy and Validation This tool analyzes Time in Range,3 24-hour glucose control, and glycemic variability
Patient Compliance Record up to 288 data points each day
Contextual Data Capture events easily with our mobile app for cause-effect analysis

iPRO™2 CGM USE IN CLINICAL STUDIES

When used in clinical studies, iPro™2 CGM 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 studies in less time.

iPro™2 CGM can uncover important insights for your studies such as:

  • Safety
  • Time in range
  • High and low glucose episodes
  • 24-hour average glucose level
  • Glycemic variability (GV) indices
Screenshot of an iPro2 CGM Pattern Snapshot generated for a sample patient.

EXAMPLES OF CGM USED IN CLINICAL STUDIES

Study Title and Leader What the iPro™2 Showed in the Study
Pharmaceutical Industry: 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 substudy1 Drug Efficacy and Superiority: Dulaglutide provided an improved balance between the proportion of values within the near normoglycemia range and values within the hypoglycemic range.
Research Centers and Universities: Effects of vildagliptin twice daily vs. sitagliptin once daily on 24-hour acute glucose fluctuations2 Drug Safety and Efficacy: Vildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled type 2 diabetes.
Nutrition/Microbiome Industry: Personalized Nutrition by Prediction of Glycemic Responses3 Treatment Safety and Efficacy: Personalized diets may successfully modify elevated postprandial blood glucose and its metabolic consequences.
Clinical Research Organizations: VARIATION study4 Treatment Safety and 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.

MEDICAL EDUCATION PROGRAMS

Engage with real-world case studies and explore special considerations for therapy management.

CONTACT US

If you have any queries regarding how CGM can be used in your clinical studies, feel free to contact us at:

rs.nripro2@medtronic.com

1-818-576-4415

DATA ANALYSIS

We help customers in capturing CGM datasets relevant for the study and deep-dive analysis of important CGM parameters.

 

 

1

Jendle J, Testa M, Martin S, Jiang H, Milicevic Z. 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, 206;18:999-1005. DOI:10.1111/dom.

2

Marfella R, Barbieri M, Grella R, et al. Effects of vildagliptin twice daily vs. sitagliptin once daily on 24-hour acute glucose fluctuations. Journal of Diabetes and Its Complications. 2010;24:79-83.

3

Zeevi D, Korem T, Zmora N, et al. Personalised nutrition by prediction of glycemic responses. Cell. 2015;163:1079-1094.

4

Bajaj HS, Venn K, Ye C 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. Diabetes Care. 2017;40:190-200.