CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 235 enrolled
Drug / intervention
Bedtime insulin Aspart (Novolog)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01702311
NCT01702311N/ACompleted

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

Emory University·interventional·Posted Oct 8, 2012·Updated Jan 3, 2018

In Brief

A clinical study evaluating Bedtime insulin Aspart (Novolog) for Diabetes. Completed, enrolled 235 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.7 years ago

Interventions

Bedtime insulin Aspart (Novolog)drug

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