Diabetes Mellitus, Type 2Phase 4NCT00841919
Insulin Therapy in the Hospital Comparing Two Protocols
A Phase 4 study testing Glargine insulin, NPH insulin and regular insulin and lispro insulin in people with Diabetes Mellitus, Type 2, run by Cook County Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Glargine insulin, NPH insulin and regular insulin and lispro insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2009
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled blood sugar:
- Random blood sugar ≥ 200mg/dl
- Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.
- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- Patient is able to eat and oral feeding is expected.
Who cannot join
- Patients receiving inpatient oral hypoglycemic agents
- Patients with chronic kidney disease stages 4 \& 5 (estimated GFR of <30ml/min) and on dialysis
- Patient with chronic liver disease
- Patient with hypoglycemia unawareness
- Pregnancy
- Patients who are on "NPO" for medical reasons.
- Patient is expected to stay in the hospital for less than 3 days.
- Patient on a new inpatient insulin regimen for > 36 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Jr. Hospital
Chicago, Illinois, 60612
About this study
Official title: Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Glargine insulin, NPH insulin and regular insulin, lispro insulin
- Keywords
- Diabetes, Inpatient, Insulin, Insulin pen
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glargine insulinDrug
Also called Lantus insulin
The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
NPH insulin and regular insulinDrug
The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
lispro insulinDrug
Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. Receives: Drug: NPH insulin and regular insulin |
| 1 | Experimental | The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff Receives: Drug: Glargine insulin; Drug: lispro insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of correct timing of insulin and food administration
Measured: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
Pre and post- prandial glucose levels
Measured: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
Secondary outcomes (4)
Length of hospital stay
Measured: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
Nursing staff satisfaction scores for evaluation of the two methods
Measured: 24 hours after last patient is discharged
Hypoglycemia rates.
Measured: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
High excursions of blood sugars (>300 mg/dl).
Measured: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Eli Lilly and Company
- Investigators
- Leon Fogelfeld, MD, Principal investigator, John H Stroger Jr. HospitalEvelyn Lacuesta, MD, Study chair, John H Stroger Jr. HospitalYannis Guerra, MD, Study chair, Rush University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841919
- Sponsor's protocol ID
- BBJHS200901
- Status last verified
- Sep 2009
- First submitted
- 9 Feb 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerra YS, Lacuesta EA, Yrastorza R, Miernik J, Shakya N, Fogelfeld L. Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. Endocr Pract. 2011 Sep-Oct;17(5):737-46. doi: 10.4158/EP10358.OR.
PubMed 21454236
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
- ClinicalTrials.gov ID
- NCT00841919
- Acronym / sponsor ID
- BBJHS200901
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Inpatient, Insulin, Insulin pen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Feb 2009 (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.
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: NPH insulin and regular insulinThe active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. |
| 1 | Experimental | Drug: Glargine insulin, Drug: lispro insulinThe study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Uncontrolled blood sugar:
- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- Patient is able to eat and oral feeding is expected.
Key exclusion criteria (8 listed)
- Patients receiving inpatient oral hypoglycemic agents
- Patients with chronic kidney disease stages 4 \& 5 (estimated GFR of <30ml/min) and on dialysis
- Patient with chronic liver disease
- Patient with hypoglycemia unawareness
- Pregnancy
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 |
|---|---|---|
| Glargine insulinAlso: Lantus insulinThe study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. | Drug | 1 |
| NPH insulin and regular insulinThe active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. | Drug | 2 |
| lispro insulinBolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff. | Drug | 1 |
Primary outcome
The rate of correct timing of insulin and food administration
Time frame: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
Pre and post- prandial glucose levels
Time frame: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
4 secondary outcomes
Length of hospital stay
Time frame: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
Nursing staff satisfaction scores for evaluation of the two methods
Time frame: 24 hours after last patient is discharged
Hypoglycemia rates.
Time frame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
High excursions of blood sugars (>300 mg/dl).
Time frame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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 9 Sep 2009.
- Derived from this study: PubMed 21454236Guerra YS, Lacuesta EA, Yrastorza R, Miernik J, Shakya N, Fogelfeld L. Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. Endocr Pract. 2011 Sep-Oct;17(5):737-46. doi: 10.4158/EP10358.OR.
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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.
Leon Fogelfeld, MD principal investigator
John H Stroger Jr. Hospital
Evelyn Lacuesta, MD study chair
John H Stroger Jr. Hospital
Yannis Guerra, MD study chair
Rush University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glargine insulin, NPH insulin and regular insulin and lispro insulin in people with Diabetes Mellitus, Type 2, run by Cook County Health at 1 site 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 8 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 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The rate of correct timing of insulin and food administration (time frame: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group). The study lists 2 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 NCT00841919, which also lists 1 linked publication.
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 9 Sep 2009.