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Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting information on BG levels at different time points during the day in order to assess glycemic control and to guide insulin adjustment/correction doses. Although POC testing provides insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of insulin supplements that may result in increased frequency of hypoglycemia and is expensive with an estimated annual cost in hospitals of several hundreds of millions of dollars in the U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin supplementation (correction doses) at bedtime in improving glycemic control and in preventing hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU medical and surgical patients treated with basal bolus regimen will undergo POC testing before meals and bedtime (standard of care) and half of the patients will receive insulin correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the other half will be followed without insulin supplementation at bedtime except for extreme hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and Grady Memorial Hospital.
The value of POC testing and use of insulin supplements (correction doses) in particular at bedtime, has not been prospectively evaluated in insulin-treated patients with T2DM. In the non-ICU setting, practice guidelines for the management of hyperglycemia in patients with T2DM favor the use of physiologic (basal-nutritional-correction dose) insulin regimens over sliding scale regular insulin. POC testing is invasive and painful, and has the limitation of providing glycemic profile that is an incomplete picture of BG excursions and is not always an accurate method to monitor glucose compared to laboratory assays in addition to the major expense in health care delivery. The overall objective of this proposal is to conduct the first prospective randomized controlled trial (RCT) to determine the POC glucose testing and use of insulin supplementation at bedtime in improving glycemic control and in preventing hypoglycemia in insulin-treated non-ICU patients with T2DM. The central hypothesis of this proposal is that routine BG measurement and insulin supplementation at bedtime does not improve glycemic control or reduce frequency of hypoglycemia in insulin treated medicine and surgery patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedtime supplementation | Active Comparator | 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. |
|
| no bedtime supplementation | No Intervention | Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedtime insulin Aspart (Novolog) | Drug | Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fasting Blood Glucose | 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. | up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily BG | Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Number of Hypoglycemia (BG < 70 mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo E Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25665812 | Derived | Vellanki P, Bean R, Oyedokun FA, Pasquel FJ, Smiley D, Farrokhi F, Newton C, Peng L, Umpierrez GE. Randomized controlled trial of insulin supplementation for correction of bedtime hyperglycemia in hospitalized patients with type 2 diabetes. Diabetes Care. 2015 Apr;38(4):568-74. doi: 10.2337/dc14-1796. Epub 2015 Feb 9. |
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General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
16 subjects were not included in the data analysis for bedtime supplementation arm 13 subjects were not included in the data analysis for no bedtime supplementation arm
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Fasting Blood Glucose | 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. | Posted | Mean | Standard Deviation | mg/dL | up to 10 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemic events | Endocrine disorders | Systematic Assessment | blood glucose less than 70 mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez, MD | Emory University | 404-778-1663 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups. |
| participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Daily Dose of Insulin | Compare the daily dose of insulin used among both groups | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Length of Hospital Stay | Length of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Hospital Mortality | Mortality is defined as death occurring during admission or during the hospital stay | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Nosocomial Infections (CDC) | Nosocomial infections during hospital stay as per the CDC criteria | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Pneumonia | Pneumonia (CDC criteria) | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Bacteremia | Bacteremia with SIRS/Sepsis | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg | daily while in hospital for up to 10 days |
| Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl] | Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl] | participants will be followed for the duration of hospital stay, an expected average of 6 days |
| Number of BG Within Target | Number of glucose levels within target of 70-140 mg/dl | Participants will be followed over the hospital stay- expected 6 days. |
| Number of Subjects With BG > 300 mg/dL | Subjects will be followed over the hospital stay: expected 6 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Physician Decision |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Daily BG | Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG | Posted | Mean | Standard Deviation | mmol/L | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Number of Hypoglycemia (BG < 70 mg/dl) | Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups. | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Daily Dose of Insulin | Compare the daily dose of insulin used among both groups | Posted | Mean | Standard Deviation | units/day | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospitalization | Posted | Median | Inter-Quartile Range | days | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Hospital Mortality | Mortality is defined as death occurring during admission or during the hospital stay | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Nosocomial Infections (CDC) | Nosocomial infections during hospital stay as per the CDC criteria | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Pneumonia | Pneumonia (CDC criteria) | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Bacteremia | Bacteremia with SIRS/Sepsis | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg | Posted | Number | number of events | daily while in hospital for up to 10 days |
|
|
|
| Secondary | Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl] | Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl] | Posted | Number | number of events | participants will be followed for the duration of hospital stay, an expected average of 6 days |
|
|
|
| Secondary | Number of BG Within Target | Number of glucose levels within target of 70-140 mg/dl | Posted | Number | participants | Participants will be followed over the hospital stay- expected 6 days. |
|
|
|
| Secondary | Number of Subjects With BG > 300 mg/dL | Posted | Number | participants | Subjects will be followed over the hospital stay: expected 6 days |
|
|
|
| 0 |
| 106 |
| 32 |
| 106 |
| EG001 | 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. | 0 | 100 | 26 | 100 |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |