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 Pressureadherence 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
|