Hypoglycemia, Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment will be computer based in a random fashion. Participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. Those assigned to an unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion. Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.
Interventions
DEVICEContinuing Glucose Monitor System
glucose monitoring
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes * 18 years or older
Exclusion criteria
* Type 1 diabetes * Current pregnancy or anticipation of pregnancy during study period * At screening visit, HR\> 130 or SBP\>160 or DBP\>100 which remains present on recheck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia rate | Week 16 | Overall rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison hypoglycemia rate | Week 16 | Comparison between blinded and unblinded arms |
Countries
United States
Outcome results
None listed