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

Phase 4

• Conditions: Diabetes
• Interventions: Device: Pens Device; Device: Syringe; Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)

• Registration Number: NCT02517242
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-04
• Last Update Submitted: 2015-08-04
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pens Device	Pens Device	All patients will receive pens device, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
Pens Device	Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)	All patients will receive pens device, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
Syringe	Syringe	All patients will receive syringe to insulin, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months
Syringe	Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)	All patients will receive syringe to insulin, insulin, blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). All will be evaluated monthly for six months

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin	reduction compared to baseline values at six months	reduction compared to baseline values

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	reduction compared to baseline values at six months	Monthly measurements are made
adherence	reduction compared to baseline values at six months	Monthly measurements are made
Number of pills, antidiabetics drugs and antihypertensives drugs	reduction compared to baseline values at six months	Monthly measurements are made
Number of hypoglycemias	reduction compared to baseline values at six months	Monthly measurements are made
Presence of severe hypoglycemias	reduction of the number of patients with this outcome compared to baseline values at six months	Monthly measurements are made
Presence of nocturnal hypoglycemias	reduction of the number of patients with this outcome compared to baseline values at six months	Monthly measurements are made
Presence of asyntomatic hypoglycemias	reduction of the number of patients with this outcome compared to baseline values at six months	Monthly measurements are made

Trial Locations

Locations (1)

Rafael Vaz Machry; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil