Rafael Vaz Machry1,2,3, Gustavo Fonseca Cipriani4, Henrique Umpierre Pedroso5, Rafaela Ramos Nunes5, Thayme Luisa Souza Pires5, Raquel Ferreira5, Betina Vescovi6, Gabriela Pereira de Moura6, Ticiana Costa Rodrigues4,5,7. 1. Post Graduate Program in Medical Sciences-Endocrinology, Universidade Federal Do Rio Grande Do Sul (UFRGS), Porto Alegre, Brazil. rafael.machry@gmail.com. 2. Department of Internal Medicine, Medical School, Universidade Federal de Santa Maria, Avenida Roraima 1000, Santa Maria, RS, Brazil. rafael.machry@gmail.com. 3. Medical School, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil. rafael.machry@gmail.com. 4. Post Graduate Program in Medical Sciences-Endocrinology, Universidade Federal Do Rio Grande Do Sul (UFRGS), Porto Alegre, Brazil. 5. Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. 6. Medical School, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil. 7. Division of Endocrinology, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
Abstract
BACKGROUND:Diabetes mellitus (DM) is a prevalent disease among elderly population. As the disease progresses, insulin may become necessary. The use of pens application seems to be more practical. However, the influence of this method on glycemic control needs to be defined in elderly people. METHODS: Randomized clinical trial comparing pens and syringes for insulin application among patients with type 2 DM over 60 years old and Glycated Hemoglobin > 8.5% at baseline. The follow-up was 24 weeks, with monthly medical visits to adjust the treatment. All patients received insulin NPH and, if necessary, insulin Regular. We assessed glycemic control, adherence to treatment, hypoglycemia occurrence, need for adjustment in treatment and impact on quality of life, RESULTS: We included 121 patients with mean age of 65.75 years. Sixty-one were randomized for pen group (PG) and 60 patients for syringe group (SG). At baseline, mean HbA1c was 10.34 ± 1.66% and 9.90 ± 1.25% (p = 0.103) in PG and SG respectively. Mean HbA1c was 8.39 ± 1.28% in PG and 8.85 ± 1.74% in SG (p = 0.101) at 24 weeks. However, there was a more significant reduction in PG (- 1.94 ± 1.93% in PG and - 1.04 ± 1.46% in SG, p < 0.05) during follow-up. We found no difference in treatment adherence rates, hypoglycemia, greater need for insulin doses or oral medication, and progression to basal-bolus insulin scheme. We also found no difference in the impact of the disease on quality of life between groups. CONCLUSION: Although we did not find any difference in the impact on quality of life, frequency of hypoglycemia or adherence, the PG showed a reduction in HbA1c higher in 24 weeks of follow-up. CLINICAL TRIAL REGISTRATION: NCT02517242.
RCT Entities:
BACKGROUND:Diabetes mellitus (DM) is a prevalent disease among elderly population. As the disease progresses, insulin may become necessary. The use of pens application seems to be more practical. However, the influence of this method on glycemic control needs to be defined in elderly people. METHODS: Randomized clinical trial comparing pens and syringes for insulin application among patients with type 2 DM over 60 years old and Glycated Hemoglobin > 8.5% at baseline. The follow-up was 24 weeks, with monthly medical visits to adjust the treatment. All patients received insulin NPH and, if necessary, insulin Regular. We assessed glycemic control, adherence to treatment, hypoglycemia occurrence, need for adjustment in treatment and impact on quality of life, RESULTS: We included 121 patients with mean age of 65.75 years. Sixty-one were randomized for pen group (PG) and 60 patients for syringe group (SG). At baseline, mean HbA1c was 10.34 ± 1.66% and 9.90 ± 1.25% (p = 0.103) in PG and SG respectively. Mean HbA1c was 8.39 ± 1.28% in PG and 8.85 ± 1.74% in SG (p = 0.101) at 24 weeks. However, there was a more significant reduction in PG (- 1.94 ± 1.93% in PG and - 1.04 ± 1.46% in SG, p < 0.05) during follow-up. We found no difference in treatment adherence rates, hypoglycemia, greater need for insulin doses or oral medication, and progression to basal-bolus insulin scheme. We also found no difference in the impact of the disease on quality of life between groups. CONCLUSION: Although we did not find any difference in the impact on quality of life, frequency of hypoglycemia or adherence, the PG showed a reduction in HbA1c higher in 24 weeks of follow-up. CLINICAL TRIAL REGISTRATION: NCT02517242.
Authors: Andrew J Farmer; Rafael Perera; Alison Ward; Carl Heneghan; Jason Oke; Anthony H Barnett; Mayer B Davidson; Bruno Guerci; Vivien Coates; Ulrich Schwedes; Simon O'Malley Journal: BMJ Date: 2012-02-27
Authors: Michael A Nauck; Burkhard Haastert; Christoph Trautner; Ulrich A Müller; Matthias A Nauck; Lutz Heinemann Journal: Diabetologia Date: 2014-01-21 Impact factor: 10.122