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Continuous Glucose Monitoring Following Hospital Discharge

K

Kathleen Dungan

Status

Active, not recruiting

Conditions

Type 2 Diabetes

Treatments

Device: DexCom G6

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05360056
2021H0426

Details and patient eligibility

About

In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 Diabetes
  • Basal insulin use >10 units per day
  • Hemoglobin A1c >8.0%
  • Smartphone compatible with Clarity App
  • Age ≥18 years

Exclusion criteria

  • Type 1 DM
  • Inability to consent
  • Pregnancy
  • Prisoners
  • Discharge to skilled nursing facility

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

108 participants in 1 patient group

Dexcom CGM
Experimental group
Treatment:
Device: DexCom G6

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Trevor Sobol

Data sourced from clinicaltrials.gov

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