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Active, not recruitingNCT05360056Updated Jul 21, 2026Results posted

Continuous Glucose Monitoring Following Hospital Discharge

An interventional study of DexCom G6 in Type 2 Diabetes, sponsored by Kathleen Dungan. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Kathleen Dungan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 108 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Kathleen Dungan is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 Diabetes
  • Basal insulin use >10 units per day
  • Hemoglobin A1c >8.0%
  • Smartphone compatible with Clarity App
  • Age ≥18 years

Exclusion criteria

Exclusion Criteria:

  • Type 1 DM
  • Inability to consent
  • Pregnancy
  • Prisoners
  • Discharge to skilled nursing facility
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Dexcom CGM

    Device: DexCom G6

Interventions

  • DeviceDexCom G6

    Wearable continuous glucose monitor

06

What researchers measure

Primary outcomes

  1. Change in TIR 70-180 mg/dl

    Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.

    Time frame: 12 weeks

  2. % Wear Time >70%

    The number of participants with % wear time \>70% will be reported.

    Time frame: 12 weeks

  3. DTSQc Score

    The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.

    Time frame: 12 weeks

07

Results

Posted Dec 9, 2025

Participant flow

Participant flow — Overall Study
MilestoneDexcom CGM
Started108
Completed66
Not completed42

Outcome measures

PrimaryChange in TIR 70-180 mg/dl

Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.

Time frame:
12 weeks
Reported as:
Mean · percentage of time spent 70-180 mg/dl
Change in TIR 70-180 mg/dl
percentage of time spent 70-180 mg/dlDexcom CGM
Change in TIR 70-180 mg/dl8.5 ± 28
Statistical analysis
  • Dexcom CGM · paired t-test · p = 0.03 (unadjusted p-value) · Mean difference (net): 8.51
Primary% Wear Time >70%

The number of participants with % wear time \>70% will be reported.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
% Wear Time >70%
ParticipantsDexcom CGM
% Wear Time >70%54
PrimaryDTSQc Score

The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.

Time frame:
12 weeks
Reported as:
Median · score on a scale
DTSQc Score
score on a scaleDexcom CGM
DTSQc Score8 (6 to 12)
Statistical analysis
  • Dexcom CGM · paired Wilcoxon rank test · p = <0.0001 · Wilcoxon signed rank: 9.85

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dexcom CGM1/108 (0.9%)0/108 (0%)30/108 (27.8%)
Most frequent other events
Most frequent other events
EventDexcom CGM
Sensor eventSkin and subcutaneous tissue disorders30/108

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dexcom CGM
<=18 years0
Between 18 and 65 years92
>=65 years16
Age, Continuous
Age, Continuous(years)Dexcom CGM
Mean52.3 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Dexcom CGM
Female48
Male60
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dexcom CGM
Hispanic or Latino2
Not Hispanic or Latino106
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dexcom CGM
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American62
White46
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Dexcom CGM
United States108
Baseline HbA1c
Baseline HbA1c(percentage of glycosylated hemoglobin)Dexcom CGM
Mean11.3 ± 2.0
08

Study locations

1 site
  • The Ohio State University Medical Center - Outpatient Care East
    Columbus, Ohio 43203, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 21, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — • Availability of data and materials: In accordance with institution policy on sharing data and research resources, the final research data from this study may be made available for research purposes under a limited data use agreement specifying criteria for data access, conditions for research use, privacy and confidentiality standards to ensure data security and prohibitions for manipulating data for the purposes of identifying subjects.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05360056
Lead sponsor
Kathleen Dungan
Collaborators
DexCom, Inc.
Responsible party
Kathleen Dungan (Professor, Ohio State University) — Sponsor-investigator
First posted
May 4, 2022
Start date
Apr 26, 2022
Primary completion
Aug 31, 2024
Completion
Jan 2027 (estimated)
Results posted
Dec 9, 2025
Last update
Jul 21, 2026

Study contacts

Kathleen Dungan, MD
principal investigator · OSU Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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