Trial Outcomes & Findings for Oral Anti Diabetic Agents in the Hospital (NCT NCT04416269)
NCT ID: NCT04416269
Last Updated: 2026-08-31
Results Overview
Mean daily BG concentration is compared between OADs and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
85 participants
Primary outcome timeframe
During hospital stay (up to 10 days)
Results posted on
2026-08-31
Participant Flow
Participants were recruited from Emory University Hospital, Emory University Hospital Midtown, and Grady Memorial Hospital in Atlanta, Georgia, USA. Participant enrollment began August 7, 2020 and study assessments during hospital stay were completed by April 11, 2025.
Participant milestones
| Measure |
Oral Anti-diabetes Drugs (OADs) Alone
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
Oral Anti-diabetes Drugs alone: OADs are continued at same outpatient dosage unless contraindicated. Participants are switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs is based on clinical/laboratory status. The OAD is held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.
Supplemental insulin: Supplemental (correction) lispro or aspart insulin is provided following the supplemental/sliding scale standard of care protocol for blood glucose (BG) \>140 mg/dl.
Continuous glucose monitoring (CGM): A subset of participants are randomized to take part in an optional study where a CGM device is placed for the duration of the study. CGM reports are reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment. The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
|
Basal Bolus Insulin
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
Basal bolus insulin: Basal insulin with glargine or detemir is used as per the hospital formulary.
Supplemental insulin: Supplemental (correction) lispro or aspart insulin is provided following the supplemental/sliding scale standard of care protocol for blood glucose (BG) \>140 mg/dl.
Continuous glucose monitoring (CGM): A subset of participants are randomized to take part in an optional study where a CGM device is placed for the duration of the study. CGM reports are reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment. The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
Wore the CGM
|
11
|
7
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Oral Anti-diabetes Drugs (OADs) Alone
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
Oral Anti-diabetes Drugs alone: OADs are continued at same outpatient dosage unless contraindicated. Participants are switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs is based on clinical/laboratory status. The OAD is held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.
Supplemental insulin: Supplemental (correction) lispro or aspart insulin is provided following the supplemental/sliding scale standard of care protocol for blood glucose (BG) \>140 mg/dl.
Continuous glucose monitoring (CGM): A subset of participants are randomized to take part in an optional study where a CGM device is placed for the duration of the study. CGM reports are reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment. The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
|
Basal Bolus Insulin
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
Basal bolus insulin: Basal insulin with glargine or detemir is used as per the hospital formulary.
Supplemental insulin: Supplemental (correction) lispro or aspart insulin is provided following the supplemental/sliding scale standard of care protocol for blood glucose (BG) \>140 mg/dl.
Continuous glucose monitoring (CGM): A subset of participants are randomized to take part in an optional study where a CGM device is placed for the duration of the study. CGM reports are reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment. The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Oral Anti Diabetic Agents in the Hospital
Baseline characteristics by cohort
| Measure |
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=14 Participants
|
33 Participants
n=36 Participants
|
61 Participants
n=324 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
24 Participants
n=324 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=14 Participants
|
27 Participants
n=36 Participants
|
51 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
34 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=14 Participants
|
39 Participants
n=36 Participants
|
80 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=14 Participants
|
37 Participants
n=36 Participants
|
74 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=14 Participants
|
4 Participants
n=36 Participants
|
10 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=14 Participants
|
42 Participants
n=36 Participants
|
85 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Mean daily BG concentration is compared between OADs and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Mean Daily Blood Glucose (BG) Concentration
|
164.10 milligrams per deciliter (mg/dL)
Standard Deviation 50.64
|
140.81 milligrams per deciliter (mg/dL)
Standard Deviation 23.81
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Mild hypoglycemic events are defined as BG \<70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continuous glucose monitoring (CGM).
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Mild Hypoglycemic Events
|
5 events
|
2 events
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Clinically significant hypoglycemic events are defined as BG \<54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycemic Events
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Severe hypoglycemic events are defined as BG \<40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Severe Hypoglycemic Severe (<40 mg/dl) Events
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Percent of Blood Glucose Values Within Target Range Without Hypoglycemia
|
71 percentage of blood glucose values
Standard Deviation 0.28
|
88 percentage of blood glucose values
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
The number of episodes of hyperglycemia (BG \> 280 mg/dl) after the first day of treatment is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Episodes of Hyperglycemia After the First Day of Treatment
|
10 events
|
2 events
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
The units of insulin administered per day is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Units Per Day of Insulin
|
12.11 units of insulin per day
Standard Deviation 9.31
|
1.10 units of insulin per day
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants in the OAD Alone study arm.
The number of participants using specific oral antidiabetic drugs (OADs) during hospitalization use was recorded. Some participants used more than one OAD.
Outcome measures
| Measure |
Basal Bolus Insulin
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
Metformin
|
—
|
29 Participants
|
|
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
Dipeptidyl peptidase-4 inhibitors (DPP4-I)
|
—
|
12 Participants
|
|
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
Sulfonylurea
|
—
|
5 Participants
|
|
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
Thiazolidinedione
|
—
|
0 Participants
|
|
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
SGLT2 inhibitors
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants in the OAD Alone study arm.
The number of patients on OADs requiring insulin rescue therapy was recorded
Outcome measures
| Measure |
Basal Bolus Insulin
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Patients on OADs Requiring Insulin Rescue Therapy
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Treatment failure is defined as mean daily BG \> 240 mg/dl or 3 consecutive BG \> 240 mg/dl.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Episodes of Treatment Failure
|
3 episodes of treatment failure
|
0 episodes of treatment failure
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who wore the CGM monitor.
Glycemic variability is measured using the coefficient of variation
Outcome measures
| Measure |
Basal Bolus Insulin
n=7 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=11 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Glycemic Variability in Participants Receiving CGM Monitoring
|
26 percentage of coefficient of variation
Standard Deviation 0.08
|
20 percentage of coefficient of variation
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who wore the CGM monitor.
The percentage of time above BG target range (\>180 mg/dl) is assessed in participants receiving CGM monitoring.
Outcome measures
| Measure |
Basal Bolus Insulin
n=7 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=11 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Percentage of Time Above BG Target Range (>180 mg/dl) in Participants Receiving CGM Monitoring
|
46.90 percentage of time
Standard Deviation 32.76
|
19.96 percentage of time
Standard Deviation 20.03
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who wore the CGM monitor.
The percentage of time in the BG target range (70-180 mg/dl) is assessed in participants receiving CGM monitoring.
Outcome measures
| Measure |
Basal Bolus Insulin
n=7 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=11 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Percentage of Time in BG Target Range (70-180 mg/dl) in Participants Receiving CGM Monitoring
|
52.62 percentage of time
Standard Deviation 32.34
|
79.99 percentage of time
Standard Deviation 20.00
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who wore the CGM monitor.
The percentage of time below BG target range (BG \<70 mg/dl) is assessed in participants receiving CGM monitoring.
Outcome measures
| Measure |
Basal Bolus Insulin
n=7 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=11 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Percentage of Time Below BG Target Range (BG <70 mg/dl) in Participants Receiving CGM Monitoring
|
0.47 percentage of time
Standard Deviation 0.80
|
0.05 percentage of time
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Hospital complications are assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Hospital Complications
|
10 count of complications
|
7 count of complications
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
In-hospital mortality is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
In-hospital Mortality
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 40 days (hospital stay plus 30 days after discharge)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Number of individual hospital complications is compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Individual Hospital Complications
Acute respiratory failure
|
0 count of complications
|
1 count of complications
|
|
Number of Individual Hospital Complications
Acute renal failure
|
3 count of complications
|
3 count of complications
|
|
Number of Individual Hospital Complications
Infection during hospitalization
|
3 count of complications
|
1 count of complications
|
|
Number of Individual Hospital Complications
Myocardial infarction
|
1 count of complications
|
1 count of complications
|
|
Number of Individual Hospital Complications
Cardiac arrhythmia
|
0 count of complications
|
0 count of complications
|
|
Number of Individual Hospital Complications
Congestive heart failure
|
2 count of complications
|
0 count of complications
|
|
Number of Individual Hospital Complications
Cardiac arrest
|
0 count of complications
|
0 count of complications
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: Data for analyzing hospital costs were not collected as the study was terminated prior to collecting cost data for any participants. Due to the early termination of the study and logistical barriers with obtaining cost data, the collection of additional patient related data did not occur.
Total hospital costs will be compared between study arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Length of hospital stay, in days, is compared between study arms. Participants were engaged in study activities for up to 10 days during hospitalization and the total number of days of hospitalization was obtained from medical records.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Length of Hospital Stay
|
7.81 days
Standard Deviation 7.33
|
9.14 days
Standard Deviation 7.03
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: Data for analyzing costs for specific therapies were not collected as the study was terminated prior to collecting cost data for any participants. Due to the early termination of the study and logistical barriers with obtaining cost data, the collection of additional patient related data did not occur.
Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 30 days of hospital dischargePopulation: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Number of hospital re-admissions within 30 days of hospital discharge are compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Hospital Re-admissions
|
12 count of hospital readmissions
|
5 count of hospital readmissions
|
SECONDARY outcome
Timeframe: within 30 days of hospital dischargePopulation: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
Number of emergency room visits within 30 days of hospital discharge is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Emergency Room Visits
|
3 count of emergency room visits
|
2 count of emergency room visits
|
SECONDARY outcome
Timeframe: During hospital stay (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis.
The number of participants transferred to the ICU is compared between study arms.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Number of Participants Requiring ICU Care
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day of hospital discharge (up to 10 days)Population: This analysis includes nurses who provided care to study participants.
The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey. The number of nurses agreeing with each item are presented here.
Outcome measures
| Measure |
Basal Bolus Insulin
n=23 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=34 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Nursing Antihyperglycemic Drug Preference Survey
Keeping blood glucose in the normal range improves my patients' outcome
|
23 Participants
|
34 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
Multi-dose insulin regimens are needed to maintain good glucose levels in hospitalized patients
|
14 Participants
|
15 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
Administering insulin significantly adds to my workload
|
16 Participants
|
27 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
I feel comfortable giving insulin injections to my patients
|
17 Participants
|
24 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
Insulin therapy is associated with high risk of hypoglycemia
|
19 Participants
|
32 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
If proven safe, OAD agents should be used instead of insulin in some hospitalized patients
|
22 Participants
|
32 Participants
|
|
Nursing Antihyperglycemic Drug Preference Survey
Insulin administration requires a similar amount of work as administering oral medications
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day of hospital discharge (up to 10 days)Population: This analysis includes participants who contributed data to the study. Two participants withdrew from the Basal Bolus Insulin study arm and data collected up until their withdrawal are included in the analysis. The last three survey items related to receiving insulin injections while hospitalized and are only relevant to the Basal Bolus Insulin study arm; participants in the OADs Alone study arm were not administered these survey items.
Participants completed a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. The number of participants agreeing with the survey item are presented here. A summary score is not calculated for this qualitative survey.
Outcome measures
| Measure |
Basal Bolus Insulin
n=42 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
Oral Anti-diabetes Drugs (OADs) Alone
n=43 Participants
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
|---|---|---|
|
Patient Antihyperglycemic Drug Preference Survey
I prefer to continue using my home oral diabetes medication while I'm in the hospital
|
20 Participants
|
33 Participants
|
|
Patient Antihyperglycemic Drug Preference Survey
I prefer to receive insulin while I'm in the hospital
|
5 Participants
|
3 Participants
|
|
Patient Antihyperglycemic Drug Preference Survey
My pre-meal insulin injections were mostly given on time (just before I ate)
|
16 Participants
|
—
|
|
Patient Antihyperglycemic Drug Preference Survey
I worry about getting a low blood sugar due to insulin treatment
|
10 Participants
|
—
|
|
Patient Antihyperglycemic Drug Preference Survey
I believe that insulin better controls my blood sugar than my home oral medication(s).
|
6 Participants
|
—
|
Adverse Events
Oral Anti-diabetes Drugs (OADs) Alone
Serious events: 4 serious events
Other events: 3 other events
Deaths: 2 deaths
Basal Bolus Insulin
Serious events: 7 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Oral Anti-diabetes Drugs (OADs) Alone
n=43 participants at risk
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
Basal Bolus Insulin
n=42 participants at risk
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.3%
1/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
2.4%
1/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.3%
1/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
0.00%
0/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Renal and urinary disorders
Acute renal failure
|
7.0%
3/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
7.1%
3/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
4.8%
2/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Surgical and medical procedures
Transfer to intensive care unit (ICU)
|
2.3%
1/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
7.1%
3/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Gastrointestinal disorders
Ileus requiring nasogastric (NG) tube
|
0.00%
0/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
2.4%
1/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
Other adverse events
| Measure |
Oral Anti-diabetes Drugs (OADs) Alone
n=43 participants at risk
Participants are people with diabetes mellitus who are admitted to the hospital and OADs are continued at same outpatient dosage, unless contraindicated.
|
Basal Bolus Insulin
n=42 participants at risk
Participants are people with diabetes mellitus who are admitted to the hospital and receive subcutaneous (SQ) insulin, which is the standard therapy for glycemic control in general medicine and surgical patients with diabetes mellitus. Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) is used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication are discontinued on admission.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
4.7%
2/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
9.5%
4/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Infections and infestations
Infection during hospitalization
|
2.3%
1/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
7.1%
3/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/43 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
4.8%
2/42 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment at 30 days after hospital discharge, up to 63 days in total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place