Clinical trial NCT03012074: Episodic to Real-Time Care in Diabetes Self-Management
Official title: From Episodic to Real-Time Care in Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II
Keywords: diabetes, mHealth, mobile health technology
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 20 patients will be interviewed via telephone at the end of their 6 month self-monitoring period 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 interviews with health care 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 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

Primary outcomes:
measure: Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data
timeFrame: 6 months
Secondary outcomes:
measure: Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
timeFrame: 6 months
measure: Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
timeFrame: 6 months
measure: Change in daily blood glucose levels in patients with diabetes over a 6 month period
timeFrame: 6 months
measure: Change in daily weight in patients with diabetes over a 6 month period
timeFrame: 6 months
measure: Change in daily physical activity in patients with diabetes over a 6 month period
timeFrame: 6 months
measure: Medication adherence Survey
timeFrame: 6 months
Other outcomes:
measure: Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.
timeFrame: 2 months
Locations:
city: Durham
country: United States
facility: Duke University School of Nursing
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Ryan J Shaw, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: