Diabetes
Conditions
Keywords
Diabetes, Point of care testing, Hypoglycemia, Basal bolus insulin
Brief summary
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.
Detailed description
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.
Interventions
DRUGBedtime insulin Aspart (Novolog)
Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients with a known history of T2DM for \> 3 months 2. Age 18-80 years 3. Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy 4. BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis
Exclusion criteria
1. Hyperglycemia without a history of diabetes 2. Acute critical illness admitted to the ICU or expected to require ICU admission 3. Receiving continuous insulin infusion 4. Clinically relevant hepatic disease 5. Patients on corticosteroid therapy 6. Patients with creatinine ≥ 3.5 mg/dl 7. Subjects unable to sign consent 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fasting Blood Glucose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemia (BG < 70 mg/dl) | 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. |
| Daily Dose of Insulin | 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 |
| Length of Hospital Stay | participants will be followed for the duration of hospital stay, an expected average of 6 days | Length of hospitalization |
| Hospital Mortality | 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 |
| Nosocomial Infections (CDC) | 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 |
| Mean Daily BG | 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 |
| Bacteremia | participants will be followed for the duration of hospital stay, an expected average of 6 days | Bacteremia with SIRS/Sepsis |
| Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | 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 |
| 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 | Acute renal failure \[rise \>50% of baseline or creatinine \>2.5 mg/dl\] |
| Number of BG Within Target | Participants will be followed over the hospital stay- expected 6 days. | Number of glucose levels within target of 70-140 mg/dl |
| Number of Subjects With BG > 300 mg/dL | Subjects will be followed over the hospital stay: expected 6 days | — |
| Pneumonia | participants will be followed for the duration of hospital stay, an expected average of 6 days | Pneumonia (CDC criteria) |
Countries
United States
Participant flow
Recruitment details
General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013
Participants by arm
| Arm | Count |
|---|---|
| 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. | 106 |
| 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. | 100 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharge less than 24 hours | 10 | 7 |
| Overall Study | Physician Decision | 3 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Bedtime Supplementation | No Bedtime Supplementation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 25 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 75 Participants | 159 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 11 | 57 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 46 Participants | 46 Participants | 92 Participants |
| Sex: Female, Male Male | 60 Participants | 54 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 106 | 26 / 100 |
| serious Total, serious adverse events | 0 / 106 | 0 / 100 |
Outcome results
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.
Time frame: up to 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bedtime Supplementation | Mean Fasting Blood Glucose | 162 mg/dL | Standard Deviation 44 |
| No Bedtime Supplementation | Mean Fasting Blood Glucose | 157 mg/dL | Standard Deviation 41 |
Secondary
Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]
Acute renal failure \[rise \>50% of baseline or creatinine \>2.5 mg/dl\]
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl] | 4 number of events |
| No Bedtime Supplementation | Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl] | 4 number of events |
Secondary
Bacteremia
Bacteremia with SIRS/Sepsis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Bacteremia | 0 number of events |
| No Bedtime Supplementation | Bacteremia | 0 number of events |
Secondary
Daily Dose of Insulin
Compare the daily dose of insulin used among both groups
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bedtime Supplementation | Daily Dose of Insulin | 39 units/day | Standard Deviation 23 |
| No Bedtime Supplementation | Daily Dose of Insulin | 44 units/day | Standard Deviation 33 |
Secondary
Hospital Mortality
Mortality is defined as death occurring during admission or during the hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Hospital Mortality | 0 number of events |
| No Bedtime Supplementation | Hospital Mortality | 1 number of events |
Secondary
Length of Hospital Stay
Length of hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bedtime Supplementation | Length of Hospital Stay | 7 days |
| No Bedtime Supplementation | Length of Hospital Stay | 6 days |
Secondary
Mean Daily BG
Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bedtime Supplementation | Mean Daily BG | 8.8 mmol/L | Standard Deviation 1.7 |
| No Bedtime Supplementation | Mean Daily BG | 8.7 mmol/L | Standard Deviation 1.8 |
Secondary
Nosocomial Infections (CDC)
Nosocomial infections during hospital stay as per the CDC criteria
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Nosocomial Infections (CDC) | 0 number of events |
| No Bedtime Supplementation | Nosocomial Infections (CDC) | 0 number of events |
Secondary
Number of BG Within Target
Number of glucose levels within target of 70-140 mg/dl
Time frame: Participants will be followed over the hospital stay- expected 6 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Number of BG Within Target | 76 participants |
| No Bedtime Supplementation | Number of BG Within Target | 74 participants |
Secondary
Number of Hypoglycemia (BG < 70 mg/dl)
Secondary outcomes include the number of hypoglycemia (BG \< 70 mg/dl) among both the groups.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Number of Hypoglycemia (BG < 70 mg/dl) | 32 number of events |
| No Bedtime Supplementation | Number of Hypoglycemia (BG < 70 mg/dl) | 26 number of events |
Secondary
Number of Subjects With BG > 300 mg/dL
Time frame: Subjects will be followed over the hospital stay: expected 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Number of Subjects With BG > 300 mg/dL | 19 participants |
| No Bedtime Supplementation | Number of Subjects With BG > 300 mg/dL | 13 participants |
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
Time frame: daily while in hospital for up to 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | 1 number of events |
| No Bedtime Supplementation | Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days | 0 number of events |
Secondary
Pneumonia
Pneumonia (CDC criteria)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bedtime Supplementation | Pneumonia | 1 number of events |
| No Bedtime Supplementation | Pneumonia | 0 number of events |