Trial Outcomes & Findings for Inpatient Diabetes on Corticosteroids (NCT NCT01970241)

NCT ID: NCT01970241

Last Updated: 2019-10-01

Results Overview

Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 85 participants
• Primary outcome timeframe: Assessed from enrollment to discharge or enrollment to day five.
• Results posted on: 2019-10-01

Participant Flow

Participant milestones

Measure	NPH With Each Steroid Dose Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids eating: 0.2 units NPH/kg High dose corticosteroids eating: 0.3 units NPH/kg Low dose corticosteroids NPO: 0.1 units NPH/kg High dose corticosteroids NPO: 0.15 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. Low dose corticosteroids: Prednisone 10 - 40 mg daily or equivalent corticosteroid dose. High dose corticosteroids: Prednisone \> 40 mg daily or equivalent corticosteroid dose.	Control Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Overall Study STARTED	46	39
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	17	8

Reasons for withdrawal

Measure	NPH With Each Steroid Dose Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids eating: 0.2 units NPH/kg High dose corticosteroids eating: 0.3 units NPH/kg Low dose corticosteroids NPO: 0.1 units NPH/kg High dose corticosteroids NPO: 0.15 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration. Low dose corticosteroids: Prednisone 10 - 40 mg daily or equivalent corticosteroid dose. High dose corticosteroids: Prednisone \> 40 mg daily or equivalent corticosteroid dose.	Control Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Overall Study Withdrawal by Subject	2	0
Overall Study Steroid d/c;discharge<48 hrs.	15	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	NPH With Corticosteroid Dose n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=31 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=29 Participants	27 Participants n=31 Participants	45 Participants n=60 Participants
Age, Categorical >=65 years	11 Participants n=29 Participants	4 Participants n=31 Participants	15 Participants n=60 Participants
Sex: Female, Male Female	15 Participants n=29 Participants	17 Participants n=31 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	14 Participants n=29 Participants	14 Participants n=31 Participants	28 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	29 participants n=29 Participants	31 participants n=31 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: Assessed from enrollment to discharge or enrollment to day five.

Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Mean POC Glucose Level Between Groups	225 mg/dl Standard Deviation 87.2	266 mg/dl Standard Deviation 69.51

SECONDARY outcome

Timeframe: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.

Hypoglycemia was defined as point of care glucose less than 70 mg/dL.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Episodes of Hypoglycemia Between NPH and Control Groups	6 Hypoglycemic episodes.	0 Hypoglycemic episodes.

OTHER_PRE_SPECIFIED outcome

Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL	33.1 Percentage of total measurements of gluc	19.2 Percentage of total measurements of gluc

OTHER_PRE_SPECIFIED outcome

Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL	42.1 Percentage of total measurements	45.3 Percentage of total measurements

OTHER_PRE_SPECIFIED outcome

Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl	16.9 Percentage of total measurements	27.0 Percentage of total measurements

OTHER_PRE_SPECIFIED outcome

Timeframe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.

Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL	5.9 Percentage of total measurements	8.5 Percentage of total measurements

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured from the day of admission till the day of discharge

Population: Difference in mean length of stay between NPH group and usual care group

Time difference of hospitalization between the NPH and control groups.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Difference in Length of Stay Between NPH and Control Group	5.21 Days Interval 1.0 to 5.25	5.23 Days Interval 1.0 to 5.25

OTHER_PRE_SPECIFIED outcome

Timeframe: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.

Population: Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 1 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the first day of the study.

The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Mean Point of Care (POC) Glucose Level in Both Groups.	246.9 mg/dL (mean values) Interval 222.0 to 271.8	280.9 mg/dL (mean values) Interval 257.6 to 304.1

OTHER_PRE_SPECIFIED outcome

Timeframe: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.

Population: Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 5 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the last day of the study.

The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Mean Point of Care (POC) Glucose Level in Both Groups.	197.3 mg/dL (mean values) Interval 170.9 to 223.6	253.5 mg/dL (mean values) Interval 228.9 to 278.1

OTHER_PRE_SPECIFIED outcome

Timeframe: plasma C-peptide was measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Age	0.197 correlation coefficient	-0.226 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With BMI	0.095 correlation coefficient	0.305 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With eGFR	-0.272 correlation coefficient	-0.063 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Serum Creatinine	0.328 correlation coefficient	-0.026 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With ALT	-0.358 correlation coefficient	0.436 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Hemoglobin A1c	-0.325 correlation coefficient	-0.251 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Duration of Diabetes	-0.320 correlation coefficient	-0.380 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Plasma Glucose	0.171 correlation coefficient	-0.053 correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured once at the time of enrollment

Outcome measures

Measure	NPH With Corticosteroid n=29 Participants Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 Participants Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Correlation of C-peptide With Length of Stay	-0.068 correlation coefficient	-0.002 correlation coefficient

Adverse Events

NPH With Corticosteroid

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	NPH With Corticosteroid n=29 participants at risk Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg NPH: NPH given per study table based on steroid dose and patient weight in kg. Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.	Control n=31 participants at risk Receive usual care with background insulin and correction factor for duration of study (2-5 days) Correction Factor: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Endocrine disorders Hypoglycemia	20.7% 6/29	0.00% 0/31

Other adverse events

Adverse event data not reported

Additional Information

Lisa Fish MD

HCMC

Phone: 612-873-2705

Email: lisa.fish@hcmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place