search
Back to results

Episodic to Real-Time Care in Diabetes Self-Management

Primary Purpose

Diabetes Mellitus, Type II

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Type 2 Diabetes Self-Management
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type II focused on measuring diabetes, mHealth, mobile health technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Type II Diabetes

Arm Description

Patients with Type II Diabetes

Outcomes

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

Secondary Outcome Measures

Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
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
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
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
Medication adherence Survey
bi-weekly text message-based surveys on medication adherence over a 6 month period.

Full Information

First Posted
December 21, 2016
Last Updated
July 1, 2020
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT03012074
Brief Title
Episodic to Real-Time Care in Diabetes Self-Management
Official Title
From Episodic to Real-Time Care in Diabetes Self-Management
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
Keywords
diabetes, mHealth, mobile health technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Type II Diabetes
Arm Type
Experimental
Arm Description
Patients with Type II Diabetes
Intervention Type
Behavioral
Intervention Name(s)
Type 2 Diabetes Self-Management
Intervention Description
Patients with Type 2 Diabetes
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
Time Frame
6 months
Title
Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
Time Frame
6 months
Title
Change in daily blood glucose levels in patients with diabetes over a 6 month period
Description
Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period
Time Frame
6 months
Title
Change in daily weight in patients with diabetes over a 6 month period
Description
Data generated from the cellular body scale and plotted as a trajectory over a 6 month period
Time Frame
6 months
Title
Change in daily physical activity in patients with diabetes over a 6 month period
Description
Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period
Time Frame
6 months
Title
Medication adherence Survey
Description
bi-weekly text message-based surveys on medication adherence over a 6 month period.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.
Description
Explore ways to achieve continual communication that addresses real-time challenges with diabetes self-management while presenting data trajectories during provider interviews.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan J Shaw, PhD, RN
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University School of Nursing
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Episodic to Real-Time Care in Diabetes Self-Management

We'll reach out to this number within 24 hrs