Trial Outcomes & Findings for Point-of-Care Glucose Testing and Insulin Supplementation (NCT NCT01702311)

NCT ID: NCT01702311

Last Updated: 2018-01-03

Results Overview

The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 235 participants
• Primary outcome timeframe: up to 10 days
• Results posted on: 2018-01-03

Participant Flow

General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013

Participant milestones

Measure	Bedtime Supplementation Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Study STARTED	122	113
Overall Study COMPLETED	106	100
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Measure	Bedtime Supplementation Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Overall Study Withdrawal by Subject	3	2
Overall Study Discharge less than 24 hours	10	7
Overall Study Physician Decision	3	4

Baseline Characteristics

Point-of-Care Glucose Testing and Insulin Supplementation

Baseline characteristics by cohort

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.	Total n=206 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 10 • n=5 Participants	57 years STANDARD_DEVIATION 11 • n=7 Participants	57 years STANDARD_DEVIATION 11 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants	75 Participants n=7 Participants	159 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	46 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	54 Participants n=7 Participants	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days

The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Mean Fasting Blood Glucose	162 mg/dL Standard Deviation 44	157 mg/dL Standard Deviation 41

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG

Outcome measures

Measure	Bedtime Supplementation n=100 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=106 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Mean Daily BG	8.8 mmol/L Standard Deviation 1.7	8.7 mmol/L Standard Deviation 1.8

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Number of Hypoglycemia (BG < 70 mg/dl)	32 number of events	26 number of events

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Compare the daily dose of insulin used among both groups

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Daily Dose of Insulin	39 units/day Standard Deviation 23	44 units/day Standard Deviation 33

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Length of hospitalization

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Length of Hospital Stay	7 days Interval 4.0 to 13.0	6 days Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Mortality is defined as death occurring during admission or during the hospital stay

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Hospital Mortality	0 number of events	1 number of events

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Nosocomial infections during hospital stay as per the CDC criteria

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Nosocomial Infections (CDC)	0 number of events	0 number of events

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Pneumonia (CDC criteria)

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Pneumonia	1 number of events	0 number of events

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Bacteremia with SIRS/Sepsis

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Bacteremia	0 number of events	0 number of events

SECONDARY outcome

Timeframe: daily while in hospital for up to 10 days

Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days	1 number of events	0 number of events

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 days

Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]	4 number of events	4 number of events

SECONDARY outcome

Timeframe: Participants will be followed over the hospital stay- expected 6 days.

Number of glucose levels within target of 70-140 mg/dl

Outcome measures

Measure	Bedtime Supplementation n=106 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Number of BG Within Target	76 participants	74 participants

SECONDARY outcome

Timeframe: Subjects will be followed over the hospital stay: expected 6 days

Outcome measures

Measure	Bedtime Supplementation n=100 Participants Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=106 Participants Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Number of Subjects With BG > 300 mg/dL	19 participants	13 participants

Adverse Events

Bedtime Supplementation

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

No Bedtime Supplementation

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bedtime Supplementation n=106 participants at risk Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed. Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.	No Bedtime Supplementation n=100 participants at risk Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
Endocrine disorders Hypoglycemic events	30.2% 32/106	26.0% 26/100

Additional Information

Guillermo Umpierrez, MD

Emory University

Phone: 404-778-1663

Email: geumpie@emory.edu

Results disclosure agreements

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