- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517242
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
Status
Unknown
Conditions
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
- Name: Rafael Vaz Machry
- Phone Number: (55)05196264337
- Email: rafael.machry@gmail.com
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on Pens Device
-
University of PittsburghNational Institute on Aging (NIA); National Center for Complementary and Integrative...Completed
-
Universidad Complutense de MadridCompleted
-
Universidad Complutense de MadridRecruiting
-
Universidad Complutense de MadridWithdrawnLateral EpicondylitisSpain
-
Hospital General Universitario ElcheCompleted
-
University of VirginiaAccelerated Care Plus; Mid-Atlantic Athletic Trainers' AssociationCompletedPatellofemoral Pain SyndromeUnited States
-
MedStar National Rehabilitation NetworkCompletedRehabilitation | Total Knee ArthroplastyUnited States
-
Hospital General Universitario ElcheUnknown
-
DyAnsys, Inc.RecruitingCancer of Cervix | Cancer of EndometriumIndia
-
Queen's University, BelfastMayo Clinic; University Hospital Southampton NHS Foundation Trust; University... and other collaboratorsCompletedPrimary Myelofibrosis | Polycythemia Vera | Essential ThrombocythemiaUnited Kingdom