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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00542698
Enrollment
52
Registered
2007-10-11
Start date
2004-07-31
Completion date
2005-12-31
Last updated
2007-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Glucose Monitor graphs, Physical Activity

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

Detailed description

Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Interventions

BEHAVIORALEffect of Physical Activity on Type II Diabetes Mellitus

Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.

Sponsors

National Institute of Nursing Research (NINR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Not able to walk ¼ mile in 10 minutes * Taking glucocoricoids * Serious health problems, such as heart problems, found on examination.

Design outcomes

Primary

MeasureTime frame
increased physical activity8 Weeks

Secondary

MeasureTime frame
BP, BMI, & HgA1c (a long term measure of blood glucose)8 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026