NCT03620357

Brief Summary

A Study to assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring (RT-CGM) and targeted learning modules versus self monitored blood glucose (SMBG) testing.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

July 31, 2018

Last Update Submit

March 18, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).

    From baseline to Month 3 (Week 12)

Study Arms (2)

Continuous Glucose Monitor (CGM) Group

EXPERIMENTAL
Device: CGM

SMBG Group

ACTIVE COMPARATOR
Device: SMBG

Interventions

CGMDEVICE

CGM Group: Dexcom G6 CGM

Continuous Glucose Monitor (CGM) Group
SMBGDEVICE

SMBG Group: Blood Glucose Meter

SMBG Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 30 years
  • Diagnosis of T2D treated with 2 or more oral anti-diabetic medications
  • HbA1c ≥ 7.8 and ≤10.5% by local lab or POC

You may not qualify if:

  • Using insulin
  • Pregnancy
  • Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Diabetes/Lipid Management and Research Center

Huntington Beach, California, 92648, United States

Location

Temecula Valley Endocrinology

Temecula, California, 92592, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

MODEL Clinical Research (Towson)

Baltimore, Maryland, 21204, United States

Location

Diabetes & Endocrine Associates, PC

Omaha, Nebraska, 68114, United States

Location

Las Vegas Endocrinology

Henderson, Nevada, 89052, United States

Location

The Docs

Las Vegas, Nevada, 89113, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

LMC Manna Research

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Price, MD

    DexCom, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, multicenter, two-arm pilot study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 8, 2018

Study Start

September 5, 2018

Primary Completion

May 27, 2020

Study Completion

November 4, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(9)CA(1)