title: Sliding Scale Insulin vs Basal-Bolus Insulin Therapy in Long-Term Care: A 21-Day Randomized Controlled Trial Comparing Efficacy, Safety and Feasibility.
abstract: BACKGROUND
  Sliding scale insulin (SSI) therapy remains a common means of insulin therapy in long-term care (LTC) for the management of type 2 diabetes mellitus, despite current recommendations not supportive of the form of therapy today. Lack of randomized trial data on the efficacy and safety of basal-bolus insulin (B-BI) therapy in nursing home residents may have precluded this form of insulin administration in the LTC setting. Our study is a comparison of the efficacy of SSI (control) and B-BI (intervention) therapies during a 21-day intervention trial in older nursing home residents.
  
  
  METHODS
  Fourteen LTC facilities in the US participated; 110 residents with type 2 diabetes volunteered to participate; 35 failed inclusion criteria, 75 signed informed written consent, and 11 were discharged to home/hospital or withdrew consent; data from 64 participants are reported. Recent fasting blood glucose (FBG), hemoglobin A1c, and chemistries were obtained. Four glucose readings (prior to breakfast, lunch, dinner, and bedtime), oral antiglycemic drug, and insulin doses and changes, and all adverse events/serious adverse events, both those related to glucose control [hypoglycemic (<70 mg/dL) and hyperglycemic (>200 mg/dL) episodes] and those unrelated, were recorded daily. Patients were randomized to either remain on SSI or be shifted to the B-BI group.
  
  
  RESULTS
  Nursing home residents 80 ± 8 (standard deviation) years, 66% female participated; Control and Intervention participants had similar age, gender, race distributions, comorbidity, and 3-day average pretrial FBG levels (all P > .05). At study end, B-BI volunteers had significantly lower 3-day average FBG levels vs pretrial (P = .0231) while SSI participants had no change in 3-day average FBG (P > .05). During the trial, participants from both groups had similar rates of hypoglycemia, hyperglycemia, other adverse events, and hospitalizations (serious adverse events) unrelated to glucose control (all P > .05).
  
  
  CONCLUSIONS
  B-BI therapy produced significantly lower average FBG levels after 21 days compared with SSI therapy; both groups had similar rates of hypo- and hyperglycemia. Switching to B-BI therapy is feasible, safe, and effective in the LTC setting.
authors.affiliation: Montefiore Medical Center (Wakefield Campus), Bronx, NY. Electronic address: dharmarajants@yahoo.com.
authors.forename: Thiruvinvamalai S
authors.initials: TS
authors.lastname: Dharmarajan
authors.affiliation: Lakeview Nursing and Rehabilitation Center, Chicago, IL; Carlton at the Lake, Chicago, IL; Cedar Pointe Rehab and Nursing, Cicero, IL; Presence Villa Scalabrini Nursing and Rehabilitation Center, Northlake, IL.
authors.forename: Dheeraj
authors.initials: D
authors.lastname: Mahajan
authors.affiliation: Lakeview Nursing and Rehabilitation Center, Chicago, IL; Carlton at the Lake, Chicago, IL; Cedar Pointe Rehab and Nursing, Cicero, IL; Presence Villa Scalabrini Nursing and Rehabilitation Center, Northlake, IL.
authors.forename: Annie
authors.initials: A
authors.lastname: Zambrano
authors.affiliation: Life Care Nursing Home, Michigan City, IN.
authors.forename: Bikash
authors.initials: B
authors.lastname: Agarwal
authors.affiliation: Life Care Nursing Home, Michigan City, IN.
authors.forename: Rachel
authors.initials: R
authors.lastname: Fischer
authors.affiliation: Beaumont Rehabilitation and Skilled Nursing Center at Worcester, Worcester, MA.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Sheikh
authors.affiliation: Beth Abraham Health Services, Bronx, NY.
authors.forename: Anna
authors.initials: A
authors.lastname: Skokowska-Lebelt
authors.affiliation: Bethany Village, Dayton, OH; Trinity Community Nursing Home, Beavercreek, OH.
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Patel
authors.affiliation: Nebraska Skilled Nursing and Rehabilitation Center, Omaha, NE.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Wester
authors.affiliation: Koester Pavilion, Troy, OH.
authors.forename: Naga P
authors.initials: NP
authors.lastname: Madireddy
authors.affiliation: St. John's Care Center, Sunrise, FL.
authors.forename: Naushira
authors.initials: N
authors.lastname: Pandya
authors.affiliation: Heritage Healthcare of Macon, Macon, GA.
authors.forename: Florence T
authors.initials: FT
authors.lastname: Baralatei
authors.affiliation: American Medical Directors Association Foundation, Columbia, MD.
authors.forename: Jackie
authors.initials: J
authors.lastname: Vance
authors.affiliation: Montefiore Medical Center (Wakefield Campus), Bronx, NY.
authors.forename: Edward P
authors.initials: EP
authors.lastname: Norkus
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D019468:Disease Management; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D008134:Long-Term Care; D008297:Male; D061214:Patient Safety; D012866:Skilled Nursing Facilities; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting
keywords: Insulin therapy for type 2 diabetes in long term care; basal-bolus insulin therapy; efficacy and safety of basal-bolus insulin therapy in long-term care; sliding scale insulin therapy