NCT07054125

Brief Summary

This research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress26%
Aug 2025Aug 2028

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 27, 2025

Last Update Submit

June 27, 2025

Conditions

Type 2 Diabetes Mellitus - Poor Control

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    12 weeks

Interventions

Education, lifestyle counseling, and peer supportBEHAVIORAL

This research study is investigating whether a diabetes virtual group visit program using a continuous glucose monitor (CGM) can help improve glucose levels and quality of life in individuals with uncontrolled type 2 diabetes. People in the study will join group visits virtually to discuss using CGM, understanding CGM, and other information about ways to bring blood sugars to your goal (nutrition, movement, reducing stress, and techniques to start a new habit).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

North and South Carolina

You may qualify if:

  • Adults aged 18 years and older
  • Diagnosed with type 2 diabetes mellitus Hemoglobin A1c \>8% Must have smartphone to connect with continuous glucose monitor

You may not qualify if:

  • Pregnancy Use of steroids Active cancer treatment Terminal illness Dementia, mental impairment Type 1 diabetes End stage renal disease, on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whole Endo

Asheville, North Carolina, 28801, United States

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Rashim Gupta, MD

CONTACT

980-349-6036rashim.gupta@wholeendo.com

Javier Samayoa, EdD

CONTACT

javier.samayoa@wholeendo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

July 8, 2025

Record last verified: 2025-06

Locations

US(1)