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Completed

NCT Number: NCT03012074

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University School of Nursing

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type 2 Diabetes Self-Management

Behavioral

Patients with Type 2 Diabetes

Primary outcomes

  1. 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 outcomes

  1. Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.

    Time frame: 6 months

  2. Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.

    Time frame: 6 months

  3. 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

  4. 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

  5. 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

  6. Medication adherence Survey

    Time frame: 6 months

    bi-weekly text message-based surveys on medication adherence over a 6 month period.

Other outcomes

  1. Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.

    Time frame: 2 months

    Explore ways to achieve continual communication that addresses real-time challenges with diabetes self-management while presenting data trajectories during provider interviews.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 6, 2017
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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