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Episodic to Real-Time Care in Diabetes Self-Management

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT03012074
First received: December 21, 2016
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes. Specifically, the study will identify strategies to help patients adapt using multiple types of self-generated diabetes-related data and help providers guide patients to better self-manage in real-time, when guidance is needed most.

Condition Intervention
Diabetes Mellitus, Type II Behavioral: Type 2 Diabetes Self-Management

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: From Episodic to Real-Time Care in Diabetes Self-Management

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months. [ Time Frame: 6 months ]
  • Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months. [ Time Frame: 6 months ]
  • Change in daily blood glucose levels in patients with diabetes over a 6 month period [ Time Frame: 6 months ]
    Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period

  • Change in daily weight in patients with diabetes over a 6 month period [ Time Frame: 6 months ]
    Data generated from the cellular body scale and plotted as a trajectory over a 6 month period

  • Change in daily physical activity in patients with diabetes over a 6 month period [ Time Frame: 6 months ]
    Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period

  • Medication adherence Survey [ Time Frame: 6 months ]
    bi-weekly text message-based surveys on medication adherence over a 6 month period.


Estimated Enrollment: 50
Actual Study Start Date: March 2, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with Type II Diabetes
Patients with Type II Diabetes
Behavioral: Type 2 Diabetes Self-Management
Patients with Type 2 Diabetes

Detailed Description:
The investigators will conduct a mixed-methods exploratory designed study and recruit 50 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months. Participants will be asked to use a phone-tethered glucose monitor, a cellular body scale, and a wrist-worn accelerometer, and respond to short bi-weekly text message-based surveys on medication adherence for 6 months. Data generated from the devices will be plotted as trajectories that will allow us to conduct trajectory analyses and identify missing data points and trends leading to attrition, in order to assess the feasibility of having patients engage in this type of self-monitoring for 6 months. A subset of 10 patients will be interviewed monthly via telephone to discuss their adaptive challenges and successes over the study period. The investigators will present the trajectories of their data during patient interviews using a visual that we will e-mail or postal mail, depending on patient preference. This will facilitate discussion of the challenges participants face in self-management and adaptive practices participants use. Following the 6 months of self-monitoring, we will conduct focus groups with providers in which the investigators will present the data trajectories and explore ways to achieve continual communication and address real-time challenges with diabetes self-management.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years old
  • able to speak and read English
  • diagnosed with type 2 diabetes mellitus
  • told by their primary care provider to monitor their blood sugar daily
  • owning and using a smart phone
  • capable of giving informed consent
  • with no pre-existing severe medical condition(s) that would interfere with study participation (e.g., renal failure, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, or cancer)

Exclusion Criteria:

  • active dementia or psychiatric illness
  • reside in a nursing home
  • participating in another self-management study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03012074

Locations
United States, North Carolina
Duke University School of Nursing
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ryan J Shaw, PhD, RN Duke University School of Nursing
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03012074     History of Changes
Other Study ID Numbers: Pro00071569
Study First Received: December 21, 2016
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 21, 2017