Type 2 Diabetes
Conditions
Brief 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.
Interventions
DEVICEDexCom G6
Wearable continuous glucose monitor
Sponsors
DexCom, Inc.
Kathleen Dungan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* Type 1 DM * Inability to consent * Pregnancy * Prisoners * Discharge to skilled nursing facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in TIR 70-180 mg/dl | 12 weeks | Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks. |
| % Wear Time >70% | 12 weeks | The number of participants with % wear time \>70% will be reported. |
| DTSQc Score | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexcom CGM DexCom G6: Wearable continuous glucose monitor | 108 |
| Total | 108 |
Baseline characteristics
| Characteristic | Dexcom CGM |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants |
| Age, Continuous | 52.3 years STANDARD_DEVIATION 10.9 |
| Baseline HbA1c | 11.3 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 108 |
| other Total, other adverse events | 30 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
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
Population: 54 participants had data at 2 weeks and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexcom CGM | Change in TIR 70-180 mg/dl | 8.5 percentage of time spent 70-180 mg/dl | Standard Deviation 28 |
Comparison: Paired t-test was performed comparing the %Time in range from 2 weeks to 12 weeksp-value: 0.03paired t-test
Primary
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
Population: 61 participants had an available DTSQ change score at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexcom CGM | DTSQc Score | 8 score on a scale |
p-value: <0.0001paired Wilcoxon rank test
Primary
% Wear Time >70%
The number of participants with % wear time \>70% will be reported.
Time frame: 12 weeks
Population: 58 participants had CGM wear time at week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexcom CGM | % Wear Time >70% | 54 Participants |