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Text messages, Usual care

Phase 2

Type 2 Diabetes Mellitus | Unknown | Metabolic |McKesson Corporation|Last Updated: Sep 1, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01569243Text to Move (TTM)StudyPHASE2 COMPLETED 126Jun 1, 2012Oct 1, 2013Sep 1, 20202 United States
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Study Endpoints
Primary Endpoints
physical activity
6 months

Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.

Secondary Endpoints
Clinical outcome
over 6 months (Day 1 and day 180)
Change in physical activity behaviors
6 months
Satisfaction with the program
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Usual care groupOTHERSubjects in this group will receive the usual standard of care available at MGH.
Text messaging groupEXPERIMENTALSubjects in this group will be enrolled to receive text messages aimed at providing bite-sized coaching based on measured step count to help improve activity levels and providing reminder, educational and motivation messages aimed at helping patients to meet their diabetes self-management goals.
Interventions
NameTypeDescription
Text messagesOTHER* Participants will receive diabetic medical care as usual. * Participants will be given an ActiHealth pedometer to measure daily activity. * In addition, they will be enrolled to receive the study text messages.
Usual careOTHER* Participants will receive diabetic medical care as usual. * In addition, participants in the control group will be given an ActiHealth pedometer to measure daily activity (step counts will be used as a proxy for activity).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adults over the age of 18 years. * HbA1c over 7.0% * Patients with a diagnosis of T2DM at MGH Chelsea, MGH Revere MGH Charlestown or MGH Everett will be offered enrollment in the study. * Must be willing to attend initial and close-out study visits * Willingness to receive a m...

Countries:United States
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