Study Questions Bedtime Insulin Supplementation in Hospitalized Patients

June 26, 2013

By Anne Harding

NEW YORK (Reuters Health) Jun 26 - For hospitalized patients with type 2 diabetes, routinely giving supplemental insulin at bedtime to treat mildly elevated blood glucose is not necessary, a new pilot study suggests.

The practice may even be harmful, one of the investigators says.

"Perhaps we don't need to be supplementing at bedtime unless the blood sugar is extremely high," Dr. Guillermo Umpierrez of Emory University School of Medicine in Atlanta, and director of the diabetes program there, told Reuters Health. "One of the main concerns that we have is that low blood sugar in the hospital is associated with increased risk of complications and maybe increased length of stay."

Dr. Umpierrez and his colleagues presented their findings at The Endocrine Society's annual meeting this month in San Francisco.

Currently, The Endocrine Society and the American Diabetes Association recommend that hospitalized insulin-dependent type 2 diabetes patients be treated with basal insulin and receive point-of-care (POC) testing before meals and at bedtime, with supplemental doses of insulin given when blood glucose is above 140 mg/dL.

To assess the efficacy and safety of the practice, Dr. Umpierrez and his team randomly assigned 121 non-ICU medical and surgical patients to receive bedtime insulin supplementation for blood glucose above 140 mg/dL, or no supplements. Patients were receiving POC testing before meals, at bedtime, and at 3 a.m. At randomization, there was no significant difference between the two groups in mean blood glucose or hemoglobin A1C.

The mean total dose of bedtime supplement was 2.2 U/day, while total daily insulin dose was 0.4 U/kg for the supplement group and 0.5 U/kg for the no-supplement group (p=0.21). Mean fasting blood glucose, the study's primary outcome, was 159 mg/dL for the no-supplement group and 160 mg/dL for the supplement group (p=0.91). Daily blood glucose and percentage of patients with blood glucose within target levels were also similar between the two groups.

There was no significant difference between the supplement and no-supplement groups in the percentage of patients with complications in the hospital or episodes of severe hypo- or hyperglycemia. "Based on these findings, we conclude that the standard practice of bedtime insulin supplementation is not clinically indicated in the management of general medicine and surgery patients with T2D," the researchers state in the abstract of their study.

"This study, although small has tremendous implications in patient care in the way that we may decrease the risk of low blood sugar in the night in some patients," Dr. Umpierrez said in an interview.

He and his colleagues are now planning a larger randomized controlled trial to further investigate whether bedtime insulin supplementation is necessary for smaller elevations in blood glucose, and whether supplementation has an impact on outcomes.

Reuters Health Information UPDATE: Study Questions Bedtime Insulin Supplementation in Hospitalized Patients Jun 28, 2013 Comment Print Email [Adds comment from ADA spokesperson in new para added to end of story posted Jun 26, 2013 as 20130626clin001.] By Anne Harding NEW YORK (Reuters Health) Jun 28 - For hospitalized patients with type 2 diabetes, routinely giving supplemental insulin at bedtime to treat mildly elevated blood glucose is not necessary, a new pilot study suggests. The practice may even be harmful, one of the investigators says. "Perhaps we don't need to be supplementing at bedtime unless the blood sugar is extremely high," Dr. Guillermo Umpierrez of Emory University School of Medicine in Atlanta, and director of the diabetes program there, told Reuters Health. "One of the main concerns that we have is that low blood sugar in the hospital is associated with increased risk of complications and maybe increased length of stay." Dr. Umpierrez and his colleagues presented their findings at The Endocrine Society's annual meeting this month in San Francisco. Currently, The Endocrine Society and the American Diabetes Association recommend that hospitalized insulin-dependent type 2 diabetes patients be treated with basal insulin and receive point-of-care (POC) testing before meals and at bedtime, with supplemental doses of insulin given when blood glucose is above 140 mg/dL. To assess the efficacy and safety of the practice, Dr. Umpierrez and his team randomly assigned 121 non-ICU medical and surgical patients to receive bedtime insulin supplementation for blood glucose above 140 mg/dL, or no supplements. Patients were receiving POC testing before meals, at bedtime, and at 3 a.m. At randomization, there was no significant difference between the two groups in mean blood glucose or hemoglobin A1C. The mean total dose of bedtime supplement was 2.2 U/day, while total daily insulin dose was 0.4 U/kg for the supplement group and 0.5 U/kg for the no-supplement group (p=0.21). Mean fasting blood glucose, the study's primary outcome, was 159 mg/dL for the no-supplement group and 160 mg/dL for the supplement group (p=0.91). Daily blood glucose and percentage of patients with blood glucose within target levels were also similar between the two groups. There was no significant difference between the supplement and no-supplement groups in the percentage of patients with complications in the hospital or episodes of severe hypo- or hyperglycemia. "Based on these findings, we conclude that the standard practice of bedtime insulin supplementation is not clinically indicated in the management of general medicine and surgery patients with T2D," the researchers state in the abstract of their study. "This study, although small has tremendous implications in patient care in the way that we may decrease the risk of low blood sugar in the night in some patients," Dr. Umpierrez said in an interview. He and his colleagues are now planning a larger randomized controlled trial to further investigate whether bedtime insulin supplementation is necessary for smaller elevations in blood glucose, and whether supplementation has an impact on outcomes.

In the meantime, however, the American Diabetes Association's Senior Vice President for Medical Information, Dr. Jane Chiang, told Reuters Health she has some reservations. "(The) study is interesting and demonstrates the utility of capillary point-of-care glucose testing in the non-ICU hospital setting," Dr. Chiang said. "However, it is difficult to draw conclusions on the safety and efficacy of bedtime insulin dosing given the relatively small numbers (n=121)."

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