Glucose and Activity Tracking for Sedentary Behavior Inte... | NCT07524205

Studies
Glucose and Activity Tracking for Sedentary Behavior Interventions in Older People With Type 2 Diabetes (TRACK T2D)

NCT07524205

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2

Interventions

SB Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2026Actual

Primary Completion Date

Oct 31, 2027Estimated

Completion Date

Oct 31, 2027Estimated

First Submitted Date

Apr 3, 2026

First Submission Date that Met QC Criteria

Apr 3, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overarching goal of this explanatory mixed methods study is to evaluate how older people living with type 2 diabetes (T2D) integrate continuous glucose monitor (CGM) and activity data in diabetes self-management, and how this technology supports reduced sedentary behavior (SB) and improved glucose control.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SB Intervention	Experimental	10-day self-monitoring and reminders of sedentary behavior, followed by 30 days of activity monitoring	Behavioral: SB Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SB Intervention	Behavioral	Self-monitoring and reminders about sedentary behavior	SB Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Responsiveness to Fitbit 'stand' prompts	From FitBit data	Day 10

Secondary Outcomes

Measure	Description	Time Frame
Visit Completion Rate	Percent of visits completed	Day 10
Wear Time: activePAL	Total time worn	Day 10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 55 years and older
Self-reported T2D for ≥5 years
Speak and read English

Exclusion Criteria:

Type 1 diabetes
Use of a CGM for ≥1 month in past 1 year
Not willing to use/wear the CGM, activPAL, or Fitbit
Dementia
Any of the following conditions that may impact SB:
1. Severe pulmonary disease
2. Severe osteoarthritis
3. Class III/IV heart failure
4. Require wheelchair or walker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mary Whipple, PhD, RN, PHN, FSVM, FAHA	Contact	612-626-5823		sittingresearch@umn.edu

Overall Officials

Name	Affiliation	Role
Mary Whipple, PhD, RN, PHN, FSVM, FAHA	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided