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

Information source: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Ticiana da Costa Rodrigues, Principal Investigator, Affiliation: Hospital de ClĂ­nicas de Porto Alegre

Overall contact:
Rafael Vaz Machry, Phone: (55)05196264337, Email: rafael.machry@gmail.com

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.

Clinical Details

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

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

Primary outcome: Glycated Hemoglobin

Secondary outcome:

Blood Pressure

adherence

Number of pills, antidiabetics drugs and antihypertensives drugs

Number of hypoglycemias

Presence of severe hypoglycemias

Presence of nocturnal hypoglycemias

Presence of asyntomatic hypoglycemias

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Rafael Vaz Machry, Phone: (55)05196264337, Email: rafael.machry@gmail.com

Rafael Vaz Machry, Porto Alegre, Rio Grande do Sul 90035-903, Brazil; Recruiting
Rafael Vaz Machry, Phone: (55)5196264337
Additional Information

Starting date: May 2015
Last updated: August 4, 2015

Page last updated: August 23, 2015

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