Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes
  • Diabetes Mellitus - Type 2
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities. Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional ...

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities. Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional intake, which increase the risk of hypoglycemia (low blood sugars). Many Clinical guidelines recommend the use of insulin, as the preferred therapy for glycemic (sugar) control for most patients with type 2 diabetes (T2D). The use of insulin is effective in improving glycemic control, but associated with high rates of hypoglycemia in LTC residents with T2D. This high rate of hypoglycemia is concerning, because hypoglycemia has been associated with many complications and mortality. The bedside capillary point of care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital and in LTC facilities. POC testing is usually performed before meals and at bedtime. Continuous Glucose Monitoring (CGM) measures glucose every 5-15 minutes, thus provides a more complete glycemic profile during 24-hours when compared to POC testing. The investigators propose to conduct a randomized controlled trial to determine whether the use of Dexcom CGM with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm compared to standard of care using capillary POC testing, will facilitate diabetes treatment and reduce the risk of hypoglycemia in patients with T2D in LTC facilities. Participants in the standard of care group will also wear a CGM (blinded one). Potential Participants will be identified from electronic medical records and enrolled during admission to subacute rehabilitation (SAR)and long-term care (LTC) skilled nursing care facilities and will be followed up for up to sixty (60) days or discharge (whichever comes sooner). Subjects will be compensated for their participation. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of older adults with diabetes in SAR and LTC facilities.

Tracking Information

NCT #
NCT04818242
Collaborators
DexCom, Inc.
Investigators
Principal Investigator: Guillermo Umpierrez Emory University