Trial Outcomes & Findings for Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM) (NCT NCT00979628)
NCT ID: NCT00979628
Last Updated: 2018-10-10
Results Overview
The primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
375 participants
Primary outcome timeframe
Randomization and 24 hrs after treatment
Results posted on
2018-10-10
Participant Flow
375 subjects were enrolled in the study from January 2010 to June 2012. The study is conducted in 3 states and patients were enrolled from 3 hospitals in state of Georgia; 1 hospitals in south Carolina and 1 hospitals in Texas.
24 subjects that were consented were withdrawn from the study and not included in analysis because they meet exclusion criteria like transferring to ICU; receiving treatment \< 24 hrs and for receiving steroids
Participant milestones
| Measure |
Basal Bolus
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Basal Plus Regimen
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Sliding Scale Regular Insulin (SSRI)
four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Overall Study
STARTED
|
153
|
142
|
80
|
|
Overall Study
COMPLETED
|
144
|
133
|
74
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
6
|
Reasons for withdrawal
| Measure |
Basal Bolus
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Basal Plus Regimen
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Sliding Scale Regular Insulin (SSRI)
four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Overall Study
received regimen < 24 hours
|
7
|
6
|
5
|
|
Overall Study
received steroids
|
1
|
1
|
0
|
|
Overall Study
transferred to ICU
|
1
|
2
|
1
|
Baseline Characteristics
Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
Basal Bolus
n=153 Participants
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 units/kg/day (plus corrective doses of glulisine as needed)
|
Basal Plus Regimen
n=142 Participants
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed
|
Sliding Scale Regular Insulin (SSRI)
n=80 Participants
four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 11 • n=39 Participants
|
58.6 years
STANDARD_DEVIATION 13 • n=41 Participants
|
58.7 years
STANDARD_DEVIATION 12 • n=35 Participants
|
58.6 years
STANDARD_DEVIATION 12 • n=31 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=39 Participants
|
65 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
160 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
215 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Randomization and 24 hrs after treatmentThe primary outcome is to determine the effective glycemic control among the subjects that received Basal Plus (glargine once daily plus corrective doses of glulisine before meals and bedtime as needed), Basal Bolus approach of glargine once daily plus corrective doses of glulisine before meals and Sliding Scale Regular Insulin (SSRI). Glycemic control is measured by mean blood glucose(BG) levels in mg/dL after first day of treatment and are compared to mean BG levels at randomization among subjects treated with Basal Plus, Basal -bolus and SSRI treatments. The optimal glycemic control is achieved when BG levels are between 70 mg/dL -140 mg/dL. The BG levels levels below 70 mg/dL are regarded as hypoglycemic events. The BG levels levels above 140 mg/dl are considered elevated and Hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions).
Outcome measures
| Measure |
Basal Plus Regimen
n=133 Participants
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Basal Bolus
n=144 Participants
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Sliding Scale Regular Insulin (SSRI)
n=74 Participants
four-time daily in patients with type 2 diabetes mellitus (T2DM) admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments
Randomization
|
194 mg/dL
Standard Deviation 45
|
200 mg/dL
Standard Deviation 49
|
187 mg/dL
Standard Deviation 43
|
|
Mean Blood Glucose Levels (Measured in mg/dL) at Randomization Are Compared to Mean Blood Glucose Levels After First Day of Treatment Among Subjects Treated With Basal Plus, Basal -Bolus and SSRI Treatments
After first day of therapy
|
163 mg/dL
Standard Deviation 37
|
156 mg/dL
Standard Deviation 36
|
172 mg/dL
Standard Deviation 41
|
SECONDARY outcome
Timeframe: During hospital stay, up to 12 daysEffective Glycemic control is also assessed by number of hypoglycemia events among the patients treated with Basal plus, basal-bolus and SSRI treatments. Hypoglycemia event is defined as blood glucose levels \<70 mg/dL. Number of patients with hypoglycemia episodes that are treated with Basal plus, basal-bolus and SSRI treatment regimens during their hospital stay are examined and compared.
Outcome measures
| Measure |
Basal Plus Regimen
n=144 Participants
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Basal Bolus
n=133 Participants
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Sliding Scale Regular Insulin (SSRI)
n=74 Participants
four-time daily in patients with type 2 diabetes mellitus (T2DM) admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Number of Patients With Hypoglycemia Events (Blood Glucose Levels < 70 mg/dL) During Their Hospital Stay That Are Treated With Basal Plus, Basal-bolus and SSRI Treatments
|
23 participants
|
17 participants
|
2 participants
|
Adverse Events
Basal Plus Regimen
Serious events: 18 serious events
Other events: 16 other events
Deaths: 3 deaths
Basal Bolus
Serious events: 22 serious events
Other events: 13 other events
Deaths: 0 deaths
Sliding Scale Regular Insulin (SSRI)
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Basal Plus Regimen
n=133 participants at risk
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Basal Bolus
n=144 participants at risk
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Sliding Scale Regular Insulin (SSRI)
n=74 participants at risk
four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Severe hypoglycemia
|
0.75%
1/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.69%
1/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.00%
0/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
|
Infections and infestations
wound infections
|
2.3%
3/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.69%
1/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
1.4%
1/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
2.1%
3/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.00%
0/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.5%
2/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.69%
1/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
0.00%
0/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
|
Renal and urinary disorders
Acute Renal Failure
|
6.0%
8/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
6.2%
9/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
4.1%
3/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
|
Infections and infestations
Bacteremia
|
3.0%
4/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
4.9%
7/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
4.1%
3/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
Other adverse events
| Measure |
Basal Plus Regimen
n=133 participants at risk
glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
|
Basal Bolus
n=144 participants at risk
glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)
|
Sliding Scale Regular Insulin (SSRI)
n=74 participants at risk
four-time daily in patients with T2DM admitted to general medicine and surgery wards.
sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.0%
16/133 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
9.0%
13/144 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
4.1%
3/74 • The time frame for the study is the duration of hospital stay of the patients. Among the study patients the mean (standard deviation) hospital stay for Basal bolus patients was 5.9 (5) days; Basal plus patients was 6(6) days; SSRI patients was 5.5(5) days.
Subjects were followed daily by the investigators for complications and mortality. But the study end points on adverse events are related to blood glucose (BG) levels. Hypoglycemia is defined as BG levels of \< 70 mg/dL. Severe hypoglycemia is defined as blood glucose levels of \< 40 mg/dL. Inpatient hyperglycemia defined as a fasting BG \>126 mg/dl or random BG \>200 mg/dl on two or more occasions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place