NCT03208686

Brief Summary

The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

July 3, 2017

Last Update Submit

March 3, 2025

Conditions

Type2 Diabetes

Keywords

GenderMenBlack/African AmericanSelf-management

Outcome Measures

Primary Outcomes (1)

  • Blood glucose levels

    A1c

    4 Months

Study Arms (1)

Intervention Group

OTHER

A single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer.

Behavioral: Intervention Group

Interventions

Intervention GroupBEHAVIORAL

A single-arm intervention comprised of (a) 10 weekly discussion groups; (b) motivational text messages; (c) a remote sensing persuasive health technology - a cloud-based cellular glucometer connected to a dedicated web site to reduce A1c by 0.5% by improving diabetes self-management behaviors.

Intervention Group

Eligibility Criteria

Age21 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identification
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Black/African American
  • Male
  • Tyep 2 Diabetes
  • years old or older
  • Owns cell or smart (mobile) phone or willing to use one if provided

You may not qualify if:

  • Non-ambulatory
  • Serious physical illness
  • Psychiatric diagnosis of serious mental illness
  • Serious diabetes complications impeding meaningful participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

CoitusMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

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

July 3, 2017

First Posted

July 5, 2017

Study Start

April 1, 2019

Primary Completion

December 19, 2019

Study Completion

December 19, 2019

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

US(1)