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

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02517242

13-0485

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Pens Device

Experimental group

Description:

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

Treatment:

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

Device: Pens Device

Syringe

Active Comparator group

Description:

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

Treatment:

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

Device: Syringe