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

August 4, 2015 updated by: Ticiana da Costa Rodrigues, Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Rafael Vaz Machry
        • Contact:
          • Rafael Vaz Machry
          • Phone Number: (55)5196264337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated Hemoglobin
Time Frame: reduction compared to baseline values at six months
reduction compared to baseline values
reduction compared to baseline values at six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ticiana da Costa Rodrigues, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13-0485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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