Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Hospitalization
Brief summary
This program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their glucose parameters in real-time similar to other continuously monitored vital signs. The CGM will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. Health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.
Detailed description
All patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by an advanced practice diabetes nurse for glucose management during their hospitalization. All patients included in the study will receive a CGM. Patients with type 2 diabetes will be randomized to control (blinded CGM glucose values to APN, care team and researchers) or intervention (CGM blood glucose values will be used to aid with glucose management during the hospitalization). In addition, a research only supplemental order set will be implemented for all study participants. The order set focuses on any glucose point of care test that is between 70-79 mg/dL or ≥ 250 at bedtime or before the 4 am usual care blood glucose check. The goal is to prevent hypoglycemia and hyperglycemia for all study patients. The advanced practice diabetes nurse will work with the physician in charge of the patient's care as well as the patient's care team.
Interventions
DEVICEReal-time CGM data
Sponsors
Scripps Whittier Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expected length of hospital stay of at least 48 hours * One of the following: 1. Diagnosed with diabetes type 1 OR 2. Diagnosed with diabetes type 2, with an HbA1c \> 8% or 3 point-of-care blood glucose (POC) \> 200, and requiring insulin during this hospitalization. * Literate in English or Spanish
Exclusion criteria
(not all listed): * Pregnant or post-partum * Patient admitted to OB unit * Patient in ICU or with insulin drip * Known allergy to adhesives * Anticipated CT/MRI/diathermy procedure within 48 hours from admission (patients with a planned operation within 48 hours from admission may be included in the study post operation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | Up to 30 days | Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL |
| Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | Up to 30 days | Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL |
| Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | Up to 30 days | Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Time in Hypoglycemia (<70 mg/dL) | Up to 30 days | Percentage of time a person's blood glucose level stays within a specific range \< 70 mg/dL |
| Percentage Time in Hyperglycemia (>250 mg/dL) | Up to 30 days | Percentage of time a person's blood glucose level stays within a specific range \> 250 mg/dL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention For type 2 patients in the intervention group, CGM data will be viewed real-time.
Real-time CGM data | 57 |
| Control For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Real-time CGM data | 53 |
| Observational T1D For type 1 patients in the observational group, CGM data will be viewed real-time.
Real-time CGM data | 47 |
| Total | 157 |
Baseline characteristics
| Characteristic | Total | Control | Observational T1D | Intervention |
|---|---|---|---|---|
| Age, Continuous | 61.94 years STANDARD_DEVIATION 13.22 | 60.94 years STANDARD_DEVIATION 12.37 | 43.6 years STANDARD_DEVIATION 12.73 | 62.88 years STANDARD_DEVIATION 14.01 |
| BMI | 30.27 kg/m2 | 30.65 kg/m2 | — | 29.9 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants | 42 Participants | 16 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 10 Participants | 31 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HbA1c at Hospital Admission | 9.075 percentage | 8.65 percentage | 9.5 percentage | 9.5 percentage |
| Point of Care (POC) Blood Glucose Testing at Hospital Admission | 253.25 mg/dL | 245.5 mg/dL | 334.00 mg/dL | 261 mg/dL |
| Region of Enrollment United States | 110 participants | 53 participants | 47 participants | 57 participants |
| Serum Creatinine at Hospital Admission | 1.00 mg/dL | 1.00 mg/dL | — | 1.00 mg/dL |
| Sex: Female, Male Female | 82 Participants | 30 Participants | 22 Participants | 30 Participants |
| Sex: Female, Male Male | 75 Participants | 23 Participants | 25 Participants | 27 Participants |
| Type 2 Diabetes Duration | 17.37 years STANDARD_DEVIATION 10.89 | 18.51 years STANDARD_DEVIATION 12.04 | — | 16.23 years STANDARD_DEVIATION 9.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 53 | 0 / 47 |
| other Total, other adverse events | 0 / 57 | 0 / 53 | 0 / 47 |
| serious Total, serious adverse events | 0 / 57 | 0 / 53 | 0 / 47 |
Outcome results
Primary
Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | 25.31 percentage of time during CGM use |
| Control | Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | 19.89 percentage of time during CGM use |
| Observational T1D | Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | 26.04 percentage of time during CGM use |
p-value: 0.146Regression, Linear
p-value: <0.05Regression, Linear
p-value: <0.05Regression, Linear
Primary
Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | 42.82 percentage of time during CGM use |
| Control | Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | 33.38 percentage of time during CGM use |
| Observational T1D | Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | 33.57 percentage of time during CGM use |
p-value: 0.0615Regression, Linear
Primary
Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | 72.83 percentage of time during CGM use |
| Control | Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | 63.95 percentage of time during CGM use |
| Observational T1D | Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | 65.97 percentage of time during CGM use |
p-value: 0.0404Regression, Linear
Secondary
Percentage Time in Hyperglycemia (>250 mg/dL)
Percentage of time a person's blood glucose level stays within a specific range \> 250 mg/dL
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Percentage Time in Hyperglycemia (>250 mg/dL) | 27.00 percentage of time during CGM use |
| Control | Percentage Time in Hyperglycemia (>250 mg/dL) | 32.96 percentage of time during CGM use |
| Observational T1D | Percentage Time in Hyperglycemia (>250 mg/dL) | 34.04 percentage of time during CGM use |
p-value: 0.0403Regression, Linear
Secondary
Percentage Time in Hypoglycemia (<70 mg/dL)
Percentage of time a person's blood glucose level stays within a specific range \< 70 mg/dL
Time frame: Up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Percentage Time in Hypoglycemia (<70 mg/dL) | 0 percentage of time during CGM use |
| Control | Percentage Time in Hypoglycemia (<70 mg/dL) | 0 percentage of time during CGM use |
| Observational T1D | Percentage Time in Hypoglycemia (<70 mg/dL) | 0 percentage of time during CGM use |
p-value: 0.268Regression, Linear