NCT03012074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 2, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

December 21, 2016

Last Update Submit

July 1, 2020

Conditions

Diabetes Mellitus, Type II

Keywords

diabetes, mHealth, mobile health technology

Outcome Measures

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

    6 months

Secondary Outcomes (6)

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

    6 months

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

    6 months

  • Change in daily blood glucose levels in patients with diabetes over a 6 month period

    6 months

  • Change in daily weight in patients with diabetes over a 6 month period

    6 months

  • Change in daily physical activity in patients with diabetes over a 6 month period

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

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

    2 months

Study Arms (1)

Patients with Type II Diabetes

EXPERIMENTAL

Patients with Type II Diabetes

Behavioral: Type 2 Diabetes Self-Management

Interventions

Type 2 Diabetes Self-ManagementBEHAVIORAL

Patients with Type 2 Diabetes

Patients with Type II Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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)

You may not qualify if:

  • active dementia or psychiatric illness
  • reside in a nursing home
  • participating in another self-management study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University School of Nursing

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ryan J Shaw, PhD, RN

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 6, 2017

Study Start

March 2, 2017

Primary Completion

May 1, 2018

Study Completion

May 30, 2020

Last Updated

July 2, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)