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Episodic to Real-Time Care in Diabetes Self-Management

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ClinicalTrials.gov Identifier: NCT03012074
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

December 21, 2016
January 6, 2017
October 9, 2018
March 2, 2017
May 1, 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT03012074 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Episodic to Real-Time Care in Diabetes Self-Management
From Episodic to Real-Time Care in Diabetes Self-Management
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.
The investigators will conduct a mixed-methods exploratory designed study and recruit 60 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months. Participants will be asked to use a wireless 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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Diabetes Mellitus, Type II
Behavioral: Type 2 Diabetes Self-Management
Patients with Type 2 Diabetes
Experimental: Patients with Type II Diabetes
Patients with Type II Diabetes
Intervention: Behavioral: Type 2 Diabetes Self-Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
50
December 1, 2018
May 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03012074
Pro00071569
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Duke University
Duke University
Not Provided
Principal Investigator: Ryan J Shaw, PhD, RN Duke University School of Nursing
Duke University
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP