NCT07524205

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

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

Study Progress1%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Responsiveness to Fitbit 'stand' prompts

    From FitBit data

    Day 10

Secondary Outcomes (4)

  • Visit Completion Rate

    Day 10

  • Wear Time: activePAL

    Day 10

  • Wear Time: CGM

    Day 10

  • Wear Time: FitBit

    Day 10

Study Arms (1)

SB Intervention

EXPERIMENTAL

10-day self-monitoring and reminders of sedentary behavior, followed by 30 days of activity monitoring

Behavioral: SB Intervention

Interventions

SB InterventionBEHAVIORAL

Self-monitoring and reminders about sedentary behavior

SB Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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:
  • Severe pulmonary disease
  • Severe osteoarthritis
  • Class III/IV heart failure
  • Require wheelchair or walker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mary Whipple, PhD, RN, PHN, FSVM, FAHA

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Whipple, PhD, RN, PHN, FSVM, FAHA

CONTACT

612-626-5823sittingresearch@umn.edu

Study Design

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

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04