RBR-7nw8wz Impact of using an automatic bolus calculator for glycemic control in patients with type 1 diabetes mellitus

Date of registration: 08/06/2018 ^(mm/dd/yyyy)
Last approval date : 08/06/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1217-8250

• Public title:

  en

  Impact of using an automatic bolus calculator for glycemic control in patients with type 1 diabetes mellitus

  pt-br

  Impacto do uso de Calculadora Automática de Bolus no controle da Glicemia de pacientes com Diabetes Mellitus tipo 1

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 50877215.2.1001.5479
    Issuing authority: Plataforma Brasil
  • 1.395.037
    Issuing authority: Comitê de Ética em Pesquisa da Irmandade da Santa Casa de Misericórdia de São Paulo

Sponsors

• Primary sponsor: Irmandade Santa Casa de Misericordia de Sao Paulo
• Secondary sponsor:
  • Institution: Irmandade Santa Casa de Misericordia de Sao Paulo
• Supporting source:
  • Institution: Irmandade Santa Casa de Misericordia de Sao Paulo

Health conditions

• Health conditions:

  en

  Diabetes mellitus; type 1 diabetes mellitus

  pt-br

  Diabetes mellitus; diabetes mellitus tipo 1

• General descriptors for health conditions:

  en

  C19 Endocrine system diseases

  pt-br

  C19 Doenças do sistema endócrino

  es

  C19 Enfermedades del sistema endocrino

• Specific descriptors:

Interventions

• Interventions:

  en

  The 26 patients were separated into two groups (Figure 1). If their mobile phone was compatible with the Accu-Chek Connect smartphone app, they were assigned to the Intervention (Connect) group (n=13), if not, they were added to the Control group (n=13). The Intervention (Connect) group used the Accu-Chek Performa blood glucometer which linked wirelessly to the mobile phone app with automatic bolus calculator (ABC), and the control group continued with the standard blood glucometer and manually calculated carbohydrate bolus. Both groups received the usual support consisting of clinical visits focused on diabetes management, and they also received consumable materials for their treatment. All patients participated in a 3-h class on carbohydrate counting delivered by the nutrition team and medical staff. Any queries they had were clarified in another class scheduled when needed. A 3-h practical training course on the Accu-Chek Performa blood glucometer was given to the Connect group. All patients attended our clinic at week 0, week 2, week 4, week 8 and week 12 (end of treatment). At each visit, blood glucose tests were evaluated after the data had been downloaded from their devices and used for dose adjustment for the whole treatment period. Hyperglycemia was defined as blood glucose values above 160 mg/dL, normoglycemia as blood glucose test values between 70 and 160 mg/dL, hypoglycemia as blood glucose test values under 70 mg/dL, and severe hypoglycemia was defined as blood glucose test values under 50 mg/dL, or a requirement for third party support. All patients were directed to test their blood glucose values at 7 points during the day (pre-prandial, post-prandial and at bedtime). HbA1c measurements were performed before beginning and after completing the study. Immunoturbidimetry was used for sample analysis. The study design was approved by the Human Beings Research Ethics Committee of Santa Casa de São Paulo and free and informed consent forms were duly signed by every patient.

  pt-br

  Os 26 pacientes foram divididos em 2 grupos de acordo com a compatibilidade do celular com o aplicativo Accu-check Connect para grupo intervenção (n=13) e grupo controle (n=13). O Grupo intervenção utilizou o monitor Accu-Chek Performa Connect que se comunica com o aplicativo do celular com calculadora automática de bolus (CAB) e o grupo controle continuou com o monitor de glicemia padrão e contagem manual de carboidratos. Ambos os grupos receberam assistência usual, que comtempla visitas clínicas focadas no manuseio do diabetes e receberam os insumos para o tratamento. Todos os participantes receberam aula de 3h de contagem de carboidratos com a equipe da nutrição juntamente com a equipe médica. Eventuais dúvidas foram esclarecidas em outra aula agendada se houvesse tal necessidade. Foi realizado um treinamento prático para o grupo intervenção com os aparelhos Accu-Chek Performa Connect com duração de 3h. As visitas médicas foram realizadas na semana 0, semana 2, semana 4, semana 8 e semana 12 (término do tratamento). Em cada visita as glicemias capilares foram avaliadas após o download dos dados coletados dos aparelhos e utilizadas para ajuste de dose durante todo o tratamento. Foi admitido por hiperglicemia valores de glicemias capilares maiores que 160mg/dL, normoglicemia valores entre 70 e 160mg/dL, hipoglicemia valores abaixo de 70mg/dL e hipoglicemia grave valores abaixo de 50mg/dL ou com necessidade de assistência por terceiros. Todos os pacientes foram orientados a medir glicemias capilares com 7 pontos (pré-prandial, pós-prandial e ao deitar). A dosagem de HbA1c foi realizada antes e ao término do estudo. A metodologia utilizada para tal análise foi Imunoturbidimetria. O estudo foi aprovado pelo comitê de Ética e Pesquisa em seres Humanos da Santa Casa de São Paulo e o termo de Consentimento Livre e Esclarecido foi assinado por todos os participantes.

• Descriptors:

  en

  E01.370.225.124.100.105 Blood Glucose Self-Monitoring

  pt-br

  E01.370.225.124.100.105 Automonitorização da Glicemia

  es

  E01.370.225.124.100.105 Automonitorización de la Glucosa Sanguínea

  en

  G07.203.650.660.500 Glycemic Index

  pt-br

  G07.203.650.660.500 Índice Glicêmico

  es

  G07.203.650.660.500 Índice Glucémico

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 03/01/2016 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  26	-	17 Y	0 -

• Inclusion criteria:

  en

  Patients >16 years old; HbA1c over ou equal to 6.5%; T1DM diagnosis for more than 1 year; being treated with multiple daily insulin injections (MDI); pre-prandial insulin doses adjusted according to carbohydrate count

  pt-br

  Pacientes maiores de 16 anos; HbA1c maior ou igual a 6.5%; com diagnóstico de DM tipo 1 há mais de 1 ano; em tratamento com múltiplas doses de insulina e doses de insulina pré-prandiais ajustadas conforme contagem de carboidratos

• Exclusion criteria:

  en

  T2DM or T1DM diagnosis for less than 1 year from the screening date; use of oral hypoglycemic agents, apart from metformin; fixed insulin injections; or using insulin dosage tables according to their blood glucose tests.

  pt-br

  pacientes com diagnóstico de DM tipo 2 ou DM1 há menos de 1 ano, uso de hipoglicemiantes orais, exceto metformina, doses fixas de insulina ou uso de tabela de doses de insulina conforme glicemias capilares

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Non-randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  The study assessed the impact of the Accu-Chek Performa blood glucometer with automatic bolus calculator (ABC) on glycemic control in T1DM patients, according to the HbA1c evaluation.

  pt-br

  Avaliar o impacto no controle glicêmico em pacientes com Diabetes Mellitus tipo 1 com o uso de monitor de glicemia Accu-Check Performa Connect com calculadora automática de bolus (CAB) por meio da avaliação evolutiva da HbA1c.

• Secondary outcomes:

  en

  The study assessed the impact of the Accu-Chek Performa blood glucometer with automatic bolus calculator (ABC) on glycemic parameters (estimated mean glycemia and percentage of hyperglycemia, normoglycemia and hypoglycemia), on glycemic variability (glycemia standard deviation) and on treatment compliance (numbers of tests/day and boluses/day).

  pt-br

  Avaliar o impacto nos parâmetros glicêmicos (glicemia média estimada e porcentagem de hiperglicemia, normoglicemia e hipoglicemia), na variabilidade glicêmica (desvio padrão da glicemia) e na aderência ao tratamento (número de testes/dia e bolus/dia).

Contacts

• Public contact
  • Full name: Cecilia K R Feder
  • • Address: Av Santo Amaro 1047 conjunto 401
    • City: Sao Paulo / Brazil
    • Zip code: 04505-001
  • Phone: +55-11-982921793
  • Email: draceciliafeder@gmail.com
  • Affiliation: Irmandade Santa Casa de Misericordia de Sao Paulo
   
• Scientific contact
  • Full name: Cecilia K R Feder
  • • Address: Av Santo Amaro 1047 conjunto 401
    • City: Sao Paulo / Brazil
    • Zip code: 04505-001
  • Phone: +55-11-982921793
  • Email: draceciliafeder@gmail.com
  • Affiliation: Irmandade Santa Casa de Misericordia de Sao Paulo
   
• Site contact
  • Full name: Cecilia K R Feder
  • • Address: Av Santo Amaro 1047 conjunto 401
    • City: Sao Paulo / Brazil
    • Zip code: 04505-001
  • Phone: +55-11-982921793
  • Email: draceciliafeder@gmail.com
  • Affiliation: Irmandade Santa Casa de Misericordia de Sao Paulo
   

Additional links:

• Download in ICTRP format