Trial Outcomes & Findings for Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU (NCT NCT00394524)

NCT ID: NCT00394524

Last Updated: 2018-10-30

Results Overview

Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: First 10 days of ICU stay
• Results posted on: 2018-10-30

Participant Flow

4 hospital centers between April 2006 and August 2008.

Of 160 enrolled, 80 were randomized to each group. Among the 80 subjects in glucommander group, 1 died prior to starting infusion and 2 were excluded because of meeting exclusion criteria for the protocol. Among 80 subject in standard group 1 withdrew consent prior to starting infusion and 3 met exclusion criteria. 153 were analyzed

Participant milestones

Measure	Glucommander continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm	Standard Insulin Infusion standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
Overall Study STARTED	80	80
Overall Study COMPLETED	77	76
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Glucommander continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm	Standard Insulin Infusion standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
Overall Study Protocol Violation	2	3
Overall Study Death	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

Baseline characteristics by cohort

Measure	Glucommander n=77 Participants insulin infusion per Glucommander	Standard Insulin Infusion n=76 Participants standard insulin infusion with columnar algorithm	Total n=153 Participants Total of all reporting groups
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	62 Participants n=5 Participants	52 Participants n=7 Participants	114 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 11 • n=5 Participants	58.5 years STANDARD_DEVIATION 13.4 • n=7 Participants	58.15 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	39 Participants n=7 Participants	83 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	76 participants n=7 Participants	153 participants n=5 Participants

PRIMARY outcome

Timeframe: First 10 days of ICU stay

Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission

Outcome measures

Measure	Glucommander n=77 Participants insulin infusion per Glucommander	Standard Insulin Infusion n=76 Participants standard insulin infusion with columnar algorithm
Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion	103.3 mg/dl Standard Deviation 8.8	117.3 mg/dl Standard Deviation 16.5

SECONDARY outcome

Timeframe: First 10 days of ICU stay

Severe hypoglycemia is defined as the blood glucose (BG) levels lower than 40 mg/dL. The number of patients enrolled among both groups with the reports of having the BG levels lower than 40 mg/dL are recorded for duration of 10 days

Outcome measures

Measure	Glucommander n=77 Participants insulin infusion per Glucommander	Standard Insulin Infusion n=76 Participants standard insulin infusion with columnar algorithm
Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm	3 Participants	4 Participants

SECONDARY outcome

Timeframe: During ICU hospitalization, up to 30 days

Mean number of days, the patients stayed in the intensive care unit are measured among glucommander group and standard insulin infusion group.

Outcome measures

Measure	Glucommander n=77 Participants insulin infusion per Glucommander	Standard Insulin Infusion n=76 Participants standard insulin infusion with columnar algorithm
Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group	8.5 days Standard Deviation 7.6	13.4 days Standard Deviation 13.8

SECONDARY outcome

Timeframe: During the complete length of hospitalization, up to 60 days

mean number of days the patients stayed in the hospital are measured among the Glucommander group and standard insulin infusion and compared

Outcome measures

Measure	Glucommander n=77 Participants insulin infusion per Glucommander	Standard Insulin Infusion n=76 Participants standard insulin infusion with columnar algorithm
Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion	23.9 days Standard Deviation 26.3	17.5 days Standard Deviation 15

Adverse Events

Glucommander

Serious events: 3 serious events

Other events: 42 other events

Deaths: 17 deaths

Standard Insulin Infusion

Serious events: 4 serious events

Other events: 41 other events

Deaths: 20 deaths

Serious adverse events

Measure	Glucommander n=77 participants at risk insulin infusion per Glucommander	Standard Insulin Infusion n=76 participants at risk standard insulin infusion with columnar algorithm
Endocrine disorders Severe Hypoglycemia	3.9% 3/77 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.	5.3% 4/76 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.

Other adverse events

Measure	Glucommander n=77 participants at risk insulin infusion per Glucommander	Standard Insulin Infusion n=76 participants at risk standard insulin infusion with columnar algorithm
Endocrine disorders Mild Hypoglycemia	42.9% 33/77 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.	30.3% 23/76 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.
Endocrine disorders Hyperglycemia	11.7% 9/77 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.	23.7% 18/76 • Adverse events for this study are collected for the duration of patients stay (patient's discharge or death) in the hospital among the Glucommander group and standard insulin infusion group which is up to 60 days The study is a comparison study between two insulin infusion algorithms among the hospitalized patients. For this study, since the intervention involves maintaining the glucose levels per the methods that are already approved the adverse events of interest are hypoglycemia and hyperglycemia.

Additional Information

Guillermo Umpierrez, MD

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

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