NCT04503239

Prediabetes and Type 2 Diabetes Data Collection Study

Prediabetes and Type 2 Diabetes Data Collection Study: T2Help

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM, medication and food intake approximately 80% of the time for each subject that completes the entire active phase.

Detailed description

In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes such as: * Sleep * Exercise/Physical activity/or lack of it * Heart rate * Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at screening and consent to the OGTT (Appendix 3) This data will address the sources and nature of blood glucose variability across the progression of PD and T2D. The data collected in this study will enable investigation into CGM-data artifacts that speak to the state and management of PD and T2D. Possible applications enabled by these data sets include: compliance with drug regimens and other lifestyle recommendations, drug titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the progression of the disease.

Conditions

• Diabetes Mellitus, Type 2
• Pre-diabetes

Interventions

Type	Name	Description
DEVICE	G6	Wear 9 wear periods of the 10-day CGM

Timeline

• Start date: 2020-07-22
• Primary completion: 2022-02-27
• Completion: 2022-02-27
• First posted: 2020-08-07
• Last updated: 2021-10-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study