Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control

Diabetes Clinical Trial

Official title:

Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic controlCONTROL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02517242
• Other study ID #: 13-0485
• Status: Recruiting
• Phase: Phase 4
• First received: August 3, 2015
• Last updated: August 4, 2015
• Start date: May 2015

Study information

• Verified date: August 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rafael Vaz Machry
• Phone: (55)05196264337
• Email: rafael.machry[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial Summary

This is a prospective, intervention, randomized, phase IV study. Patients will be included with 60 years or older, both sexes, with HbA1c >8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin NPH and regular. All patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). HbA1c will be measured at baseline, 3 and 6 months. Patients will see monthly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Sixty years or older

• Diabetes type 2 with Glycated Hemoglobin higher than 8.5%

• Using or necessity to use insulin

• Using syringe to insulin

• Using at least one oral antidiabetic

• Accept to participate

Exclusion Criteria:

• Glomerular Filtration Rate lower than 30

• Considering unfit for self administration of insulin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Pens Device

• Syringe

Other:
• Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)

Locations

Country	Name	City	State
Brazil	Rafael Vaz Machry	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated Hemoglobin	reduction compared to baseline values	reduction compared to baseline values at six months	No
Secondary	Blood Pressure	Monthly measurements are made	reduction compared to baseline values at six months	No
Secondary	adherence	Monthly measurements are made	reduction compared to baseline values at six months	No
Secondary	Number of pills, antidiabetics drugs and antihypertensives drugs	Monthly measurements are made	reduction compared to baseline values at six months	No
Secondary	Number of hypoglycemias	Monthly measurements are made	reduction compared to baseline values at six months	No
Secondary	Presence of severe hypoglycemias	Monthly measurements are made	reduction of the number of patients with this outcome compared to baseline values at six months	No
Secondary	Presence of nocturnal hypoglycemias	Monthly measurements are made	reduction of the number of patients with this outcome compared to baseline values at six months	No
Secondary	Presence of asyntomatic hypoglycemias	Monthly measurements are made	reduction of the number of patients with this outcome compared to baseline values at six months	No