Clinical trial NCT01702311: Point-of-Care Glucose Testing and Insulin Supplementation
Official title: Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Point of care testing
Hypoglycemia
Basal bolus insulin
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Fasting Blood Glucose
timeFrame: up to 10 days
Secondary outcomes:
measure: Mean Daily BG
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Number of Hypoglycemia (BG < 70 mg/dl)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Daily Dose of Insulin
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Length of Hospital Stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Hospital Mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Nosocomial Infections (CDC)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Pneumonia
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Bacteremia
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days
timeFrame: daily while in hospital for up to 10 days
measure: Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Number of BG Within Target
timeFrame: Participants will be followed over the hospital stay- expected 6 days.
measure: Number of Subjects With BG > 300 mg/dL
timeFrame: Subjects will be followed over the hospital stay: expected 6 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo E Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.