Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
NCT ID: NCT03620357
Last Updated: 2021-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2018-09-05
2020-11-04
Brief Summary
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Detailed Description
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At time of enrollment, participants will undergo a run-in period of blinded CGM for a duration of 10 days to collect baseline data. Baseline Patient Report Outcome (PRO) surveys will be administered at the start of run-in.
The study design includes a run-in phase, a study phase and a follow up visit. During the study phase, participants will be randomized into two groups - CGM Group or SMBG Group. For the RT-CGM Group, the study comprises of 4 scheduled clinic visits at baseline (after Run-In), week 4, week 8, and week 12 to collect data on episodic RT-CGM use. During these visits, RT-CGM insertions will take place at baseline, week 4 and week 8 clinic visits, with each wear period lasting a duration of 10 days. For the SMBG Group, the study comprises of 3 scheduled clinic visits at baseline (after Run-In), week 8 (to collect data on episodic blinded CGM use) and week 12. CGM insertions will take place at week 8 with a wear period of 10 days. Both groups will have HbA1c collected at week 0 and week 12. The same PRO surveys administered at start of run-in will be administered again at week 12. There will not be therapeutic changes during the study phase unless needed for safety.
There will be phone/remote visits by a study site clinician at weeks 2, 6 and 10 in both groups to review the SMBG or CGM data. During these remote visits, there will be discussions about what the subjects have learned from their glucose monitoring and what the study clinician has observed.
All subjects will be scheduled for a follow up visit at Month 9 to obtain local lab or POC HbA1c. Diabetes medications (classifications only) will also be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous Glucose Monitor (CGM) Group
CGM
CGM Group: Dexcom G6 CGM
SMBG Group
SMBG
SMBG Group: Blood Glucose Meter
Interventions
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CGM
CGM Group: Dexcom G6 CGM
SMBG
SMBG Group: Blood Glucose Meter
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T2D treated with 2 or more oral anti-diabetic medications
* HbA1c ≥ 7.8 and ≤10.5% by local lab or POC
Exclusion Criteria
* Pregnancy
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
30 Years
ALL
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Price, MD
Role: STUDY_DIRECTOR
DexCom, Inc.
Locations
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Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
Temecula Valley Endocrinology
Temecula, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
MODEL Clinical Research (Towson)
Baltimore, Maryland, United States
Diabetes & Endocrine Associates, PC
Omaha, Nebraska, United States
Las Vegas Endocrinology
Henderson, Nevada, United States
The Docs
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
LMC Manna Research
Toronto, Ontario, Canada
Countries
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Other Identifiers
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PTL903076
Identifier Type: -
Identifier Source: org_study_id
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