Randomized controlled trial of insulin supplementation for correction of bedtime hyperglycemia in hospitalized patients with type 2 diabetes
Open accessAbstract
OBJECTIVE: Clinical guidelines recommend point-of-care glucose testing and the use of supplemental doses of rapid-acting insulin before meals and at bedtime for correction of hyperglycemia. The efficacy and safety of this recommendation, however, have not been tested in the hospital setting. RESEARCH DESIGN AND METHODS: In this open-label, randomized controlled trial, 206 general medicine and surgery patients with type 2 diabetes treated with a basal-bolus regimen were randomized to receive either supplemental insulin (n = 106) at bedtime for blood glucose (BG) >7.8 mmol/L or no supplemental insulin (n = 100) except for BG >19.4 mmol/L. Point-of-care testing was performed before meals, at bedtime, and at 3:00 a.m. The primary outcome was the difference in fasting BG. In addition to the intention-to-treat analysis, an as-treated analysis was performed where the primary outcome was analyzed for only the bedtime BG levels between 7.8 and 19.4 mmol/L. RESULTS: There were no differences in mean fasting BG for the intention-to-treat (8.8 ± 2.4 vs. 8.6 ± 2.2 mmol/L, P = 0.76) and as-treated (8.9 ± 2.4 vs. 8.8 ± 2.4 mmol/L, P = 0.92) analyses. Only 66% of patients in the supplement and 8% in the no supplement groups received bedtime supplemental insulin. Hypoglycemia (BG <3.9 mmol/L) did not differ between groups for either the intention-to-treat (30% vs. 26%, P = 0.50) or the as-treated (4% vs. 8%, P = 0.37) analysis. CONCLUSIONS: The use of insulin supplements for correction of bedtime hyperglycemia was not associated with an improvement in glycemic control. We conclude that routine use of bedtime insulin supplementation is not indicated for management of inpatients with type 2 diabetes.
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The basal-bolus regimen is labor intensive, needs multiple daily injections, and carries hypoglycemia risk affecting 10% to 30% of noncritically ill patients.
“Though effective, the basal-bolus regimen is labor intensive, requires several injections per day, and is associated with risk of hypoglycemia, affecting up to 10% to 30% of noncritically ill persons.102,1333”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1333]
The Introduction (page unavailable) describes multiple daily basal and mealtime insulin injections, and the Conclusions report a 20%–30% rate of mild hypoglycemia with basal-bolus treatment. The cited 10% lower bound is not reported. The Introduction calls point-of-care testing labor intensive, rather than explicitly applying that description to the basal-bolus regimen. (LLM, conf=0.82)
Experimental — accuracy not yet measuredRCTs showed that a basal prandial regimen with insulin analogs improved glycemic control and reduced hospital complications in general medical and surgical T2D patients compared with sliding-scale regular insulin alone.
“RCTs have shown that treatment with a basal prandial regimen using insulin analogs improved glycemic control with fewer hospital complications in general medical and surgical persons with T2D compared with sliding-scale regular insulin alone.92,107,108,1333–1336”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1333]
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- Authors
- Vellanki, P., Bean, R., Oyedokun, F. A., Pasquel, F. J., Smiley, D., Farrokhi, F., Newton, C., Peng, L., & Umpierrez, G. E.
- Affiliations
- Emory University (US)
- Corresponding author
- Umpierrez, Guillermo E.
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2015-02-09
- Volume
- 38
- Issue
- 4
- Pages
- 568-574
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC4370326
- OpenAlex
- W2058690973
- Cited by
- 36
- References
- 24
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 3 · 2023: 1 · 2022: 3 · 2021: 3 · 2020: 3 · 2019: 1 · 2018: 5 · 2017: 1 · 2016: 7 · 2015: 2
- FWCI
- 4.34
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR000454)
- National Center for Research Resources (M01-RR00039, UL1RR025008, M01RR000039)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, insulin supplementation, multiple daily insulin injections, hospitalized patients, point-of-care glucose testing, hypoglycemia, fasting blood glucose, glycemic control, rapid-acting insulin
- MeSH terms
- Aged, Blood Glucose, Circadian Rhythm, Diabetes Mellitus, Type 2, Drug Administration Schedule, Female, Hospitalization, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Isophane, Male, Middle Aged, Sleep, Insulin, Long-Acting, Insulin, Short-Acting, Insulin Lispro, Meals
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