Diabetes MellitusNCT01563419
Clinical Usefulness of a Magnifier for Insulin Pen
A study testing Indicator magnifying window (Izumi Planning Co.) in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually need insulin therapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Indicator magnifying window (Izumi Planning Co.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Jan 2012
- Phase
- Interventional
- 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
- clinical diagnosis of diabetes mellitus
- over 60 years old
- who have self-injected insulin with insulin pens
Who cannot join
- who have visual acuity less than 20/200 for each eye
- who had surgery on his/her eyes within a week
Trial locations and contacts
1 site in 1 country.
About this study
Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually need insulin therapy. Patients who need insulin therapy are older and have poor visual acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic patients who had used insulin pens.
- Conditions
- Diabetes Mellitus
- Being tested
- Indicator magnifying window (Izumi Planning Co.)
- Keywords
- Insulin, Diabetes, Low vision
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indicator magnifying window (Izumi Planning Co.)Device
IZUMI PLANNING CO,.LTD.Tokyo.Japan
Material: Polypropylene with polycarbonate lens
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | dialing up the selected dose of insulin pens without an indicator magnifying window |
| Magnifier | Experimental | dialing up the selected dose of insulin pens clipped on an indicator magnifying window Receives: Device: Indicator magnifying window (Izumi Planning Co.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time spent to complete dialing up insulin pens
The investigators ask participants to dial up the random dose of insulin pens between 30 and 40 and measured the time spent to complete dialing up.
Measured: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
Secondary outcomes (6)
the dosing accuracy
The investigators ask participants to dial up the random dose of insulin pens between 30 and 40 and check whether they dial up the selected dose correctly.
Measured: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
the convenience in using insulin pens
By structured questionnaires, the investigators ask participants about the convenience in dialing up to correct doses of insulin pens.
Measured: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the self-confidence in using insulin pens
By structured questionnaires, the investigators ask participants about the self-confidence in dialing up to correct doses of insulin pens
Measured: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the need for glasses in using insulin pens
By structured questionnaires, the investigators ask participants about the need for glasses in dialing up to correct doses of insulin pens
Measured: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the preferences for the use of a magnifier
By structured questionnaires, the investigators ask participants whether they prefer the use of a magnifier
Measured: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the recommendation for the use of a magnifier
By structured questionnaires, the investigators ask participants whether they recommend the use of a magnifier to others.
Measured: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Min Cho, Seoul National University Hospital
- Investigators
- Young Min Cho, MD,PhD, Study chair, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563419
- Sponsor's protocol ID
- magnifier
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of a Magnifier for Insulin Pen
- ClinicalTrials.gov ID
- NCT01563419
- Acronym / sponsor ID
- magnifier
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin, Diabetes, Low vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Mar 2012 (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.
Insulin treatment is crucial for glucose control. Many patients with type 2 diabetes exhibit inadequate glycemic control in spite of combination of oral antidiabetic drugs and eventually need insulin therapy. Patients who need insulin therapy are older and have poor visual acuity, which predispose to inaccurate dosing and consequent hyper or hypoglycemia.In this study, the investigators examined the clinical usefulness of a magnifier for elderly diabetic patients who had used insulin pens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –dialing up the selected dose of insulin pens without an indicator magnifying window |
| Magnifier | Experimental | Device: Indicator magnifying window (Izumi Planning Co.)dialing up the selected dose of insulin pens clipped on an indicator magnifying window |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of diabetes mellitus
- over 60 years old
- who have self-injected insulin with insulin pens
Key exclusion criteria (2 listed)
- who have visual acuity less than 20/200 for each eye
- who had surgery on his/her eyes within a week
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 |
|---|---|---|
| Indicator magnifying window (Izumi Planning Co.)IZUMI PLANNING CO,.LTD.Tokyo.Japan Material: Polypropylene with polycarbonate lens | Device | Magnifier |
Primary outcome
the time spent to complete dialing up insulin pens
Time frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
The investigators ask participants to dial up the random dose of insulin pens between 30 and 40 and measured the time spent to complete dialing up.
6 secondary outcomes
the dosing accuracy
Time frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes
the convenience in using insulin pens
Time frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the self-confidence in using insulin pens
Time frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the need for glasses in using insulin pens
Time frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the preferences for the use of a magnifier
Time frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
the recommendation for the use of a magnifier
Time frame: the duration of to complete filling up the questionnaires, an expected average of 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Young Min Cho, MD,PhD study chair
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indicator magnifying window (Izumi Planning Co.) in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 27 Mar 2012. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time spent to complete dialing up insulin pens (time frame: from to start dialing up the selected dose to to complete dialing up, assessed up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2012.