HyperglycemiaNCT00240149
Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
A study testing Regular Insulin via Insulin-Glucose Algorithm in people with Hyperglycemia, run by Stanford University at 2 sites in United States.
Trial summary
Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased morbidity and mortality when blood sugar concentrations are closely controlled. The safety and efficacy of this type of blood sugar management has not been studied in the pediatric ICU population. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Regular Insulin via Insulin-Glucose Algorithm
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 1-18 years of age admitted to the PICU at LPCH will be asked to participate in a randomized feasibility trial during their hospitalization. This initial age restriction will be adjusted as experience is gained.
- Patient displays evidence of hyperglycemia (>150mg/dl) Exclusion Criteria:Initially, patients younger than 5 years of age will be excluded. These patients appear to have a higher sensitivity to insulin as well as a proposed higher risk of hypoglycemia. Since this is a feasibility trial using insulin to control glucose, we feel that it would be prudent to establish success in an older patient population before extending the study to include younger children and infants. In addition, our PICU study revealed no significant increased risk of hyperglycemia based on age. This age restriction will be adjusted after the mid-study data analysis.
- Patients who are known to be pregnant will be excluded.
- Patients who have known platelet dysfunction will be excluded.
- Patients without intact, uninfected skin at the future site of sensor insertion.
- Study patients re-admitted to the PICU after hospital discharge will not be eligible for repeat participation
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lucile Packard Childrens Hospital - PICU
Stanford, California, 94305
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit
Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased morbidity and mortality when blood sugar concentrations are closely controlled. The safety and efficacy of this type of blood sugar management has not been studied in the pediatric ICU population. Based on the current pediatric literature data as well as our extensive retrospective study, blood sugar concentrations have a potentially profound role to play among PICU patients. In preparation for a multi-center randomized control trial, we propose a prospective feasibility study to evaluate the safety and effectiveness of using an insulin delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility trial is that uniformly monitoring and controlling blood glucose with a Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and consistent means of delivering insulin to manage glucose in the pediatric intensive care unit.
Read the detailed description
The Diabetes Control and Complications Trial (DCCT) demonstrated that long-term microvascular complications from hyperglycemia could be reduced in adolescents and adults by intensive diabetes management.1 Hyperglycemia has also been shown to be an acute risk factor for poor outcome in a variety of adult cases including trauma, cardiac,2 surgical, stroke, and head injury patients.
Moreover, control of hyperglycemia improves the outcome of these critically ill adult patients in intensive care unit (ICU) settings. In a prospective randomized study, Van den Berghe et al. reported on 1,548 patients admitted to an adult surgical ICU. During admission, intensive treatment with intravenous insulin to control hyperglycemia in both diabetics and non-diabetics reduced the risk of death by 42%, overall in-hospital mortality by 34%, sepsis by 46%, and acute renal failure by 41%.3 Utilizing less stringent criteria for glycemic control, Finney et al. also reported similar findings.4
While these studies have emphasized the value of controlling hyperglycemia in the adult ICU, there have been relatively few studies evaluating the incidence of hyperglycemia, and its correlates, in the PICU, and no interventional studies. 5,6
Because of the limited pediatric data available and the impressive findings displayed in the adult literature, we performed a retrospective chart review of all pediatric patients admitted to our PICU over a 13 month period. The goals of this study were to gain a better understanding of current glucose monitoring techniques in the PICU as well how hyperglycemia correlates with morbidity and mortality in pediatrics.
The results confirmed our hypothesis that a higher peak glucose during an admission is associated with longer LOS and a higher mortality rate. 7
As demonstrated in adults, control of hyperglycemia has the potential to have a profound impact on the morbidity and mortality of patients in the PICU. Our preliminary study clearly showed that hyperglycemia is associated with increased LOS and mortality. Unfortunately, the true clinical impact of controlling hyperglycemia on pediatric ICU patients is not known. By more accurately and more safely controlling hyperglycemia in the PICU, we have the opportunity to improve on the standard of care as well as to potentially improve the overall clinical outcome of PICU patients. Once the use of an insulin delivery algorithm and our methods for glucose monitoring have been explored in this randomized controlled feasibility study, this form of improved glucose management can be formally tested in a large multi-center trial in the PICU setting.
- Conditions
- Hyperglycemia
- Being tested
- Regular Insulin via Insulin-Glucose Algorithm
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Insulin via Insulin-Glucose AlgorithmDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Aim #1 Intervention): Randomized study of strict glucose control in a pediatric intensive care unit (PICU) using a discrete-closed-loop (DCL) insulin algorithm.
Safely reach and maintain a glucose range goal of 90-120 mg/dl in the treatment group within 4 hrs of initiating therapy.
Maintain at least 90% of glucose values within the target range.
Have fewer than 1% of glucose values below 50 mg/dl.
d) Show a significant difference in glucose values (mean glucose values and area under the curve) between the Treatment and Control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Bruce A. Buckingham, Sub-investigator, Stanford UniversityDarrell M Wilson, Sub-investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240149
- Sponsor's protocol ID
- 95771
- Other IDs
- Medtronic Minimed - Pending, NIH Training Grant - DK07217
- Status last verified
- Nov 2007
- First submitted
- 13 Oct 2005
- Last updated
- 20 Dec 2007
- Results posted
- No
Publications
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. JAMA. 2003 Oct 15;290(15):2041-7. doi: 10.1001/jama.290.15.2041.
PubMed 14559958Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.
PubMed 10711923van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Cochran A, Scaife ER, Hansen KW, Downey EC. Hyperglycemia and outcomes from pediatric traumatic brain injury. J Trauma. 2003 Dec;55(6):1035-8. doi: 10.1097/01.TA.0000031175.96507.48.
PubMed 14676647Srinivasan V, Spinella PC, Drott HR, Roth CL, Helfaer MA, Nadkarni V. Association of timing, duration, and intensity of hyperglycemia with intensive care unit mortality in critically ill children. Pediatr Crit Care Med. 2004 Jul;5(4):329-36. doi: 10.1097/01.pcc.0000128607.68261.7c.
PubMed 15215001Wintergerst KA, Deiss D, Buckingham B, Cantwell M, Kache S, Agarwal S, Wilson DM, Steil G. Glucose control in pediatric intensive care unit patients using an insulin-glucose algorithm. Diabetes Technol Ther. 2007 Jun;9(3):211-22. doi: 10.1089/dia.2006.0031.
PubMed 17561791
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00240149
- Acronym / sponsor ID
- 95771
- Conditions
- Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2005
- Study completion
- Mar 2006
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased morbidity and mortality when blood sugar concentrations are closely controlled. The safety and efficacy of this type of blood sugar management has not been studied in the pediatric ICU population. Based on the current pediatric literature data as well as our extensive retrospective study, blood sugar concentrations have a potentially profound role to play among PICU patients. In preparation for a multi-center randomized control trial, we propose a prospective feasibility study to evaluate the safety and effectiveness of using an insulin delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility trial is that uniformly monitoring and controlling blood glucose with a Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and consistent means of delivering insulin to manage glucose in the pediatric intensive care unit.
Detailed description
The Diabetes Control and Complications Trial (DCCT) demonstrated that long-term microvascular complications from hyperglycemia could be reduced in adolescents and adults by intensive diabetes management.1 Hyperglycemia has also been shown to be an acute risk factor for poor outcome in a variety of adult cases including trauma, cardiac,2 surgical, stroke, and head injury patients.
Moreover, control of hyperglycemia improves the outcome of these critically ill adult patients in intensive care unit (ICU) settings. In a prospective randomized study, Van den Berghe et al. reported on 1,548 patients admitted to an adult surgical ICU. During admission, intensive treatment with intravenous insulin to control hyperglycemia in both diabetics and non-diabetics reduced the risk of death by 42%, overall in-hospital mortality by 34%, sepsis by 46%, and acute renal failure by 41%.3 Utilizing less stringent criteria for glycemic control, Finney et al. also reported similar findings.4
While these studies have emphasized the value of controlling hyperglycemia in the adult ICU, there have been relatively few studies evaluating the incidence of hyperglycemia, and its correlates, in the PICU, and no interventional studies. 5,6
Because of the limited pediatric data available and the impressive findings displayed in the adult literature, we performed a retrospective chart review of all pediatric patients admitted to our PICU over a 13 month period. The goals of this study were to gain a better understanding of current glucose monitoring techniques in the PICU as well how hyperglycemia correlates with morbidity and mortality in pediatrics.
The results confirmed our hypothesis that a higher peak glucose during an admission is associated with longer LOS and a higher mortality rate. 7
As demonstrated in adults, control of hyperglycemia has the potential to have a profound impact on the morbidity and mortality of patients in the PICU. Our preliminary study clearly showed that hyperglycemia is associated with increased LOS and mortality. Unfortunately, the true clinical impact of controlling hyperglycemia on pediatric ICU patients is not known. By more accurately and more safely controlling hyperglycemia in the PICU, we have the opportunity to improve on the standard of care as well as to potentially improve the overall clinical outcome of PICU patients. Once the use of an insulin delivery algorithm and our methods for glucose monitoring have been explored in this randomized controlled feasibility study, this form of improved glucose management can be formally tested in a large multi-center trial in the PICU setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients between 1-18 years of age admitted to the PICU at LPCH will be asked to participate in a randomized feasibility trial during their hospitalization. This initial age restriction will be adjusted as experience is gained.
- Patient displays evidence of hyperglycemia (>150mg/dl) Exclusion Criteria:Initially, patients younger than 5 years of age will be excluded. These patients appear to have a higher sensitivity to insulin as well as a proposed higher risk of hypoglycemia. Since this is a feasibility trial using insulin to control glucose, we feel that it would be prudent to establish success in an older patient population before extending the study to include younger children and infants. In addition, our PICU study revealed no significant increased risk of hyperglycemia based on age. This age restriction will be adjusted after the mid-study data analysis.
- Patients who are known to be pregnant will be excluded.
- Patients who have known platelet dysfunction will be excluded.
- Patients without intact, uninfected skin at the future site of sensor insertion.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Insulin via Insulin-Glucose Algorithm | Drug | – |
Primary outcome
Specific Aim #1 Intervention): Randomized study of strict glucose control in a pediatric intensive care unit (PICU) using a discrete-closed-loop (DCL) insulin algorithm.
Safely reach and maintain a glucose range goal of 90-120 mg/dl in the treatment group within 4 hrs of initiating therapy.
Maintain at least 90% of glucose values within the target range.
Have fewer than 1% of glucose values below 50 mg/dl.
d) Show a significant difference in glucose values (mean glucose values and area under the curve) between the Treatment and Control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2007.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 14559958Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. JAMA. 2003 Oct 15;290(15):2041-7. doi: 10.1001/jama.290.15.2041.
- Background: PubMed 10711923Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Background: PubMed 14676647Cochran A, Scaife ER, Hansen KW, Downey EC. Hyperglycemia and outcomes from pediatric traumatic brain injury. J Trauma. 2003 Dec;55(6):1035-8. doi: 10.1097/01.TA.0000031175.96507.48.
- Background: PubMed 15215001Srinivasan V, Spinella PC, Drott HR, Roth CL, Helfaer MA, Nadkarni V. Association of timing, duration, and intensity of hyperglycemia with intensive care unit mortality in critically ill children. Pediatr Crit Care Med. 2004 Jul;5(4):329-36. doi: 10.1097/01.pcc.0000128607.68261.7c.
- Background: PubMed 17561791Wintergerst KA, Deiss D, Buckingham B, Cantwell M, Kache S, Agarwal S, Wilson DM, Steil G. Glucose control in pediatric intensive care unit patients using an insulin-glucose algorithm. Diabetes Technol Ther. 2007 Jun;9(3):211-22. doi: 10.1089/dia.2006.0031.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A. Buckingham sub-investigator
Stanford University
Darrell M Wilson sub-investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Insulin via Insulin-Glucose Algorithm in people with Hyperglycemia, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Aim #1 Intervention): Randomized study of strict glucose control in a pediatric intensive care unit (PICU) using a discrete-closed-loop (DCL) insulin algorithm.. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240149, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2007.