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A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities.

ABSTRACT: Managing hyperglycemia and diabetes is challenging in geriatric patients admitted to long-term care (LTC) facilities.This randomized control trial enrolled patients with type 2 diabetes (T2D) with blood glucose (BG) >180?mg/dL or glycated hemoglobin >7.5% to receive low-dose basal insulin (glargine, starting dose 0.1?U/kg/day) or oral antidiabetic drug (OAD) therapy as per primary care provider discretion for 26?weeks. Both groups received supplemental rapid-acting insulin before meals for BG >200?mg/dL. Primary end point was difference in glycemic control as measured by fasting and mean daily glucose concentration between groups.A total of 150 patients (age: 79±8?years, body mass index: 30.1±6.5?kg/m(2), duration of diabetes mellitus: 8.2±5.1?years, randomization BG: 194±97?mg/dL) were randomized to basal insulin (n=75) and OAD therapy (n=75). There were no differences in the mean fasting BG (131±27?mg/dL vs 123±23?mg/dL, p=0.06) between insulin and OAD groups, but patients treated with insulin had greater mean daily BG (163±39?mg/dL vs 138±27?mg/dL, p<0.001) compared to those treated with OADs. There were no differences in the rate of hypoglycemia (<70?mg/dL) between insulin (27%) and OAD (31%) groups, p=0.58. In addition, there were no differences in the number of hospital complications, emergency room visits, and mortality between treatment groups.The results of this randomized study indicate that elderly patients with T2D in LTC facilities exhibited similar glycemic control, hypoglycemic events and complications when treated with either basal insulin or with oral antidiabetic drugs.ClinicalTrials.gov Identifier: NCT01131052.

SUBMITTER: Pasquel FJ

PROVIDER: S-EPMC4553905 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities.

Pasquel Francisco J FJ Powell Winter W Peng Limin L Johnson Theodore M TM Sadeghi-Yarandi Shadi S Newton Christopher C Smiley Dawn D Toyoshima Marcos T MT Aram Pedram P Umpierrez Guillermo E GE

BMJ open diabetes research & care 20150828 1

<h4>Background</h4>Managing hyperglycemia and diabetes is challenging in geriatric patients admitted to long-term care (LTC) facilities.<h4>Methods</h4>This randomized control trial enrolled patients with type 2 diabetes (T2D) with blood glucose (BG) >180 mg/dL or glycated hemoglobin >7.5% to receive low-dose basal insulin (glargine, starting dose 0.1 U/kg/day) or oral antidiabetic drug (OAD) therapy as per primary care provider discretion for 26 weeks. Both groups received supplemental rapid-ac ...[more]

PMID: 26336609

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Project description:OBJECTIVES:Safe and easily implemented treatment regimens are needed for the management of patients with type 2 diabetes mellitus (T2DM) in long-term care (LTC) and skilled nursing facilities. DESIGN:This 6-month open-label randomized controlled trial compared the efficacy and safety of a DPP4 inhibitor (linagliptin) and basal insulin (glargine) in LTC residents with T2DM. SETTINGS:Three LTC institutions affiliated with a community safety-net hospital, US Department of Veterans Affairs and Emory Healthcare System in Atlanta, Georgia. PARTICIPANTS:A total of 140 residents with T2DM treated with oral antidiabetic agents or low-dose insulin (?0.1 U/kg/d), with fasting or premeal blood glucose (BG) > 180 mg/dL and/or HbA1c >7.5%. INTERVENTION:Baseline antidiabetic therapy, except metformin, was discontinued on trial entry. Residents were treated with linagliptin 5 mg/d (n = 67) or glargine at a starting dose of 0.1 U/kg/d (n = 73). Both groups received supplemental rapid-acting insulin before meals for BG > 200 mg/dL. MEASUREMENTS:Primary outcome was mean difference in daily BG between groups. Main secondary endpoints included differences in frequency of hypoglycemia, glycosylated hemoglobin (HbA1c), complications, emergency department visits, and hospital transfers. RESULTS:Treatment with linagliptin resulted in no significant differences in mean daily BG (146 ± 34 mg/dL vs. 157 ± 36 mg/dL, P = .07) compared to glargine. Linagliptin treatment resulted in fewer mild hypoglycemic events <70 mg/dL (3% vs. 37%, P < .001), but there were no differences in BG < 54 mg/dL (P = .06) or <40 mg/dL (P = .05) compared to glargine. There were no significant between-group differences in HbA1c, length of stay, complications, emergency department visits, or hospitalizations. CONCLUSION:Treatment with linagliptin resulted in noninferior glycemic control and in significantly lower risk of hypoglycemia compared to insulin glargine in long-term care and skilled nursing facility residents with type 2 diabetes.

Project description:Pharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.In this 48-week, open-label, randomized, multi-center, crossover phase IV trial, insulin naïve type 2 diabetes patients with blood glucose not at target on oral hypoglycemic agents had basal insulin added to their treatment regimen. A total of 343 patients were randomized to either receive insulin glargine (n?=?176; sequence A) or neutral protamine Hagedorn (NPH) insulin (n?=?167; sequence B) in period 1 (weeks 1-24) and vice versa in period 2 (weeks 25-48). The primary objective was to assess patient reported outcomes using a composite Diabetes Related Quality of Life (DRQoL) score based on an unweighted Insulin Treatment Experience Questionnaire (ITEQ) score, a Problem Areas in Diabetes (PAID) questionnaire score, and the mental health score in the Short Form (SF)-12® Health Survey, analyzed by analysis of covariance (ANCOVA).Patients (mean age 62.3?±?9.0; 39.5 % female) had a mean diabetes duration of 9.6?±?5.9 years, a mean baseline HbA1c of 8.15?±?0.72 %, and a mean fasting blood glucose (FBG) level of 9.37?±?2.19 mmol/L. A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population). Combining all data from both periods for each insulin treatment, on a 0-100 scale, the mean DRQoL score was 69.6 (±9.04) with insulin glargine and 70.0 (±9.40) with NPH insulin. Neither an effect of treatment with insulin glargine vs NPH insulin (p?=?0.31) nor a period effect (p?=?0.96), nor a sequence effect (p?=?0.76) was observed using ANCOVA.The results show that in a patient population with sub-optimal glycemic control at baseline, and a low target achievement rate together with a low rate of hypoglycemia, differences in the patient reported outcomes evaluated in this study were negligible between insulin glargine and NPH insulin.Clinicaltrials.gov identifier: NCT00941369.

Project description:BackgroundEvery two years, long-term care organizations for the elderly are obliged to evaluate and publish the experiences of residents, representatives of psychogeriatric patients, and/or assisted-living clients with regard to quality of care. Our hypotheses are that publication of this quality information leads to improved performance, and that organizations with substandard performance will improve more than those whose performance is relatively good.MethodsThe analyses included organizational units that measured experiences twice between 2007 (t(0)) and 2009 (t(1)). Experiences with quality of care were measured with Consumer Quality Index (CQI) questionnaires. Besides descriptive analyses (i.e. mean, 5(th) and 95(th) percentile, and 90% central range) of the 19 CQI indicators and change scores of these indicators were calculated. Differences across five performance groups (ranging from 'worst' to 'best') were tested using an ANOVA test and effect sizes were measured with omega squared (?(2)).ResultsAt t0 experiences of residents, representatives, and assisted-living clients were positive on all indicators. Nevertheless, most CQI indicators had improved scores (up to 0.37 change score) at t(1). Only three indicators showed a minor decline (up to -0.08 change score). Change scores varied between indicators and questionnaires, e.g. they were more profound for the face-to-face interview questionnaire for residents in nursing homes than for the other two mail questionnaires (0.15 vs. 0.05 and 0.04, respectively), possibly due to more variation between nursing homes on the first measurement, perhaps indicating more potential for improvement. A negative relationship was found between prior performance and change, particularly with respect to the experiences of residents (?(2) = 0.16) and assisted-living clients (?(2) = 0.15). However, the relation between prior performance and improvement could also be demonstrated with respect to the experiences reported by representatives of psychogeriatric patients and by assisted-living clients. For representatives of psychogeriatric patients, the performance groups 1 and 2 ([much] below average) improved significantly more than the other three groups (?(2) = 0.05).ConclusionsBoth hypotheses were confirmed: almost all indicator scores improved over time and long-term care organizations for the elderly with substandard performance improved more than those with a performance which was already relatively good.

Dataset Information

A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities.

Publications

A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities.

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