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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pens Device

Intervention Type DEVICE

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

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Syringe

Intervention Type DEVICE

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

Intervention Type OTHER

Interventions

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Pens Device

Intervention Type DEVICE

Syringe

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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