Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring
Changing Activity Behavior With Glucose Sensor Feedback
2 other identifiers
interventional
52
1 country
2
Brief Summary
The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Jul 2004
Longer than P75 for phase_1 type-2-diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 11, 2007
CompletedOctober 11, 2007
October 1, 2007
October 10, 2007
October 10, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
increased physical activity
8 Weeks
Secondary Outcomes (1)
BP, BMI, & HgA1c (a long term measure of blood glucose)
8 Weeks
Study Arms (2)
Control
NO INTERVENTIONControl group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum \& update phone call at 4 weeks.
Intervention
EXPERIMENTALInterventional group received standard diabetes education, CGMS monitor, and extra educational topics including CGMS counceling.
Interventions
Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 Diabetes Mellitus
- Three month blood sugar test (HbA1c) \> 7.5%
- Not receiving insulin to manage diabetes
- Not engaged in a physical activity program more than 2 days per week
- Able to read and speak English
You may not qualify if:
- Not able to walk ¼ mile in 10 minutes
- Taking glucocoricoids
- Serious health problems, such as heart problems, found on examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Berkshire Health System
Pittsfield, Massachusetts, 01201, United States
Baystate Health System
Springfield, Massachusetts, 01199, United States
Related Publications (1)
Abstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy A Allen, Ph.D.
University of Massachusetts Worcester Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
July 1, 2004
Study Completion
December 1, 2005
Last Updated
October 11, 2007
Record last verified: 2007-10