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Completed

NCT Number: NCT01702311

Point-of-Care Glucose Testing and Insulin Supplementation

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients with a known history of T2DM for > 3 months
  • Age 18-80 years
  • Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
  • BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis

Exclusion criteria

  • Hyperglycemia without a history of diabetes
  • Acute critical illness admitted to the ICU or expected to require ICU admission
  • Receiving continuous insulin infusion
  • Clinically relevant hepatic disease
  • Patients on corticosteroid therapy
  • Patients with creatinine ≥ 3.5 mg/dl
  • Subjects unable to sign consent
  • Pregnancy

Treatment and study plan

Bedtime insulin Aspart (Novolog)

Drug

Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.

Other names: Aspart (Novolog)

Primary outcomes

  1. Mean Fasting Blood Glucose

    Time frame: 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 outcomes

  1. Mean Daily BG

    Time frame: 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

  2. Number of Hypoglycemia (BG < 70 mg/dl)

    Time frame: 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.

  3. Daily Dose of Insulin

    Time frame: 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

  4. Length of Hospital Stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Length of hospitalization

  5. Hospital Mortality

    Time frame: 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

  6. Nosocomial Infections (CDC)

    Time frame: 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

  7. Pneumonia

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Pneumonia (CDC criteria)

  8. Bacteremia

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

    Bacteremia with SIRS/Sepsis

  9. Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days

    Time frame: 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

  10. 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

    Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]

  11. Number of BG Within Target

    Time frame: Participants will be followed over the hospital stay- expected 6 days.

    Number of glucose levels within target of 70-140 mg/dl

  12. Number of Subjects With BG > 300 mg/dL

    Time frame: Subjects will be followed over the hospital stay: expected 6 days

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes

Acronym: POC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2012
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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