Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - Any
Updated:4/3/2019
Start Date:July 30, 2018
End Date:May 31, 2022
Contact:Paul Genge
Email:paul.genge@dexcom.com
Phone:858-203-6096

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Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)

A study to compare the glycemic and quality of life benefits of diabetes management using
Dexcom G6 continuous glucose monitoring (CGM) or self-monitored blood glucose (SMBG) made by
study participants and their primary care physicians. Decisions will be based on insights
from real-time use and retrospective insights, determined during remote visits.

Participants will have type 2 diabetes and be using basal insulin (with or without oral
medications and/or Glucagon-Like-Peptide-1 (GLP-1) analogue) and have an elevated Hemoglobin
A1C (HbA1c).

The study is referred to as the "Continuous Glucose MOnitoring in T2D Basal InsuLin UsErs,
also known as The MOBILE Study" and will assess potential benefits of using Continuous
Glucose Monitoring (CGM) versus traditional Blood Glucose Monitoring (BGM) in people with
Type 2 Diabetes using basal insulin with or without oral medications and who have an elevated
HbA1c between 8.0-11.5%. In this study, the investigator's role is largely advisory,
providing insights and interpretations of the glucose data obtained from BGM or CGM devices
and formally communicating medication recommendations to the participant and their treating
community clinician. Participants will be recruited from outside of the investigator team's
diabetes and endocrine practice.

The protocol comprises of 2 studies: the 1st study (also called Phase 1) will evaluate the
values of CGM after eight months of use. The 2nd study (also called Phase 2) will evaluate if
any glycemic benefits attained in study one are sustainable for an additional six months.

At the time of enrollment, participants will undergo a run-in period of blinded CGM for a
duration of 10 days. Baseline Patient Report Outcome (PRO) tools and surveys will be
administered at time of enrollment.

The study design includes two phases. During Phase 1, participants with T2D taking basal
insulin will be randomized into two groups - CGM Group or SMBG Group. Phase 1 is of 8 months
duration. The CGM group will comprise of 4 scheduled clinic visits: at week 2, month 1, month
3, and month 8. The SMBG group will comprise of 5 scheduled clinic visits: at week 2, month
1, month 3, pre-month 8 and month 8. Both groups will have structured phone/remote visits at
months 2, 4 and 6 during which glucose data will be reviewed and summarized. HbA1c will be
measured at baseline, 3 months and 8 months. Participants will complete PRO tools and surveys
at 8 months.

Phase 2 will consist of 3 groups: participants continuing use of SMBG since the beginning of
Phase 1; participants re-randomized from the Phase 1 CGM Group and assigned to SMBG;
participants re-randomized from Phase 1 CGM Group and assigned to CGM. Phase 2 duration is 6
months. This phase involves 1 phone contact and either 2 visits at Month 14 for SMBG
participants to wear blinded CGM or one visit for CGM participants. HbA1c will be measured at
14 months. Participants will complete PRO tools and surveys at month 14. For all
participants, study participation will end upon completion of month 14 visit .

Major Inclusion Criteria:

- Age 30 or older

- Diagnosis of Type 2 diabetes

- HbA1c between 8.0-11.5%

- Use of basal insulin, with or without concomitant use of oral agents or GLP-1 agonist

Major Exclusion Criteria:

- Pregnancy

- Renal disease

- Conditions that impact the stability of a HbA1c measurement

- Use of prandial insulin
We found this trial at
18
sites
Austin, Texas 78731
Principal Investigator: Lindsay Harrison, M.D.
Phone: 512-334-3505
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Amarillo, Texas 79106
Principal Investigator: William C Biggs, M.D.,F.A.C.E.
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Ann Arbor, Michigan 48109
Principal Investigator: Rodica Pop-Busui, M.D.,Ph.D.
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Atlanta, Georgia 30309
Principal Investigator: Bruce W. Bode, M.D.
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Baltimore, Maryland 21204
Principal Investigator: Philip Levin, M.D.
Phone: 443-524-1789
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Laura Young, M.D.,Ph.D.
Phone: 984-974-3009
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chicago, Illinois 60601
Principal Investigator: Grazia Aleppo, M.D.
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Dallas, Texas 75231
Principal Investigator: Stephen Aronoff, M.D.
Phone: 214-265-2157
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Detroit, Michigan 48202
Principal Investigator: Davida F Kruger, MSN, APRN-BC
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2865 Siena Heights Drive
Henderson, Nevada 89052
Principal Investigator: Quang Nguyen, D.O.
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Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist, M.D.
Phone: 208-528-9648
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Los Angeles, California 90008
Principal Investigator: Anne Peters, M.D.
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Minneapolis, Minnesota 55416
Principal Investigator: Thomas Martens, M.D.
Phone: 952-993-3705
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Nashville, Tennessee 37232
Principal Investigator: Shichun Bao, M.D.,Ph.D.
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Ogden, Utah 84405
Principal Investigator: Jack Wahlen, M.D., Ph.D.
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Saint Louis, Missouri 63110
Principal Investigator: Janet McGill, M.D.
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10140 Campus Point Drive
San Diego, California 92121
Principal Investigator: Athena Philis-Tsimikas, M.D.
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1031 Office Park Road
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava, M.D.
Phone: 515-329-6804
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