Episodic to Real-Time Care in Diabetes Self-Management

Diabetes Mellitus, Type II Clinical Trial

Official title:

From Episodic to Real-Time Care in Diabetes Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012074
• Other study ID #: Pro00071569
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2020
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Behavioral:
• Type 2 Diabetes Self-Management
Patients with Type 2 Diabetes

Locations

Country	Name	City	State
United States	Duke University School of Nursing	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.	Explore ways to achieve continual communication that addresses real-time challenges with diabetes self-management while presenting data trajectories during provider interviews.	2 months
Primary	Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data		6 months
Secondary	Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.		6 months
Secondary	Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.		6 months
Secondary	Change in daily blood glucose levels in patients with diabetes over a 6 month period	Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period	6 months
Secondary	Change in daily weight in patients with diabetes over a 6 month period	Data generated from the cellular body scale and plotted as a trajectory over a 6 month period	6 months
Secondary	Change in daily physical activity in patients with diabetes over a 6 month period	Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period	6 months
Secondary	Medication adherence Survey	bi-weekly text message-based surveys on medication adherence over a 6 month period.	6 months