DiabetesPhase 4NCT02517242
Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control
A Phase 4 study testing Pens Device, Syringe and Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) in people with Diabetes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Pens Device, Syringe and Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Glomerular Filtration Rate lower than 30
- Considering unfit for self administration of insulin
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rafael Vaz Machry
Porto Alegre, Rio Grande do Sul, 90035-903
Rafael Vaz Machry, (55)5196264337
About this study
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
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.
- Conditions
- Diabetes
- Being tested
- Pens Device, Syringe, Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pens DeviceDevice
SyringeDevice
Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)Other
| Study group | Role | What they receive |
|---|---|---|
| Pens Device | Experimental | 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 Receives: Device: Pens Device; Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) |
| Syringe | Active comparator | 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 Receives: Device: Syringe; Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
reduction compared to baseline values
Measured: reduction compared to baseline values at six months
Secondary outcomes (7)
Blood Pressure
Monthly measurements are made
Measured: reduction compared to baseline values at six months
adherence
Monthly measurements are made
Measured: reduction compared to baseline values at six months
Number of pills, antidiabetics drugs and antihypertensives drugs
Monthly measurements are made
Measured: reduction compared to baseline values at six months
Number of hypoglycemias
Monthly measurements are made
Measured: reduction compared to baseline values at six months
Presence of severe hypoglycemias
Monthly measurements are made
Measured: reduction of the number of patients with this outcome compared to baseline values at six months
Presence of nocturnal hypoglycemias
Monthly measurements are made
Measured: reduction of the number of patients with this outcome compared to baseline values at six months
Presence of asyntomatic hypoglycemias
Monthly measurements are made
Measured: reduction of the number of patients with this outcome compared to baseline values at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ticiana da Costa Rodrigues, Hospital de Clinicas de Porto Alegre
- Investigators
- Ticiana da Costa Rodrigues, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517242
- Sponsor's protocol ID
- 13-0485
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Machry RV, Cipriani GF, Pedroso HU, Nunes RR, Pires TLS, Ferreira R, Vescovi B, de Moura GP, Rodrigues TC. Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial. Diabetol Metab Syndr. 2021 Jun 12;13(1):64. doi: 10.1186/s13098-021-00675-y.
PubMed 34118981
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02517242
- Acronym / sponsor ID
- 13-0485
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2016 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pens Device | Experimental | Device: Pens Device, Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)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 |
| Syringe | Active comparator | Device: Syringe, Other: Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Glomerular Filtration Rate lower than 30
- Considering unfit for self administration of insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pens Device | Device | Pens Device |
| Syringe | Device | Syringe |
| Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) | Other | Pens Device, Syringe |
Primary outcome
Glycated Hemoglobin
Time frame: reduction compared to baseline values at six months
reduction compared to baseline values
7 secondary outcomes
Blood Pressure
Time frame: reduction compared to baseline values at six months
adherence
Time frame: 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
Number of hypoglycemias
Time frame: 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
Presence of nocturnal hypoglycemias
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 34118981Machry RV, Cipriani GF, Pedroso HU, Nunes RR, Pires TLS, Ferreira R, Vescovi B, de Moura GP, Rodrigues TC. Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial. Diabetol Metab Syndr. 2021 Jun 12;13(1):64. doi: 10.1186/s13098-021-00675-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ticiana da Costa Rodrigues principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pens Device, Syringe and Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day) in people with Diabetes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Vaz Machry ((55)05196264337, rafael.machry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (time frame: reduction compared to baseline values at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02517242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.