Type 1 DiabetesNCT04214704
Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients
A study testing Genteel lancing device and Conventional lancing device in people with Type 1 Diabetes and Type 2 Diabetes, run by Jothydev's Diabetes and Research Centre at 1 site in India.
Trial summary
The purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and HbA1c compared to the conventional lancing device. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Genteel lancing device and Conventional lancing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 4 Feb 2020to 15 Jul 2021
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Less than or equal to 70 years of age. If minor (<18 years), accompanied by caretaker.
- Diagnosed with either Type 1 or Type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects
- Presenting with an uncontrolled glycemic status (HbA1c >8.0%).
- Ready for Self-Monitoring of Blood Glucose (SMBG) practices.
- Attending physician prescribed testing at least 2 times per day
- Judged by the study trainer to be competent to correctly use Genteel AND demonstrated to the trainer that the subject can use the Genteel device properly.
Who cannot join
- More than 70 years and less than 5 years
- HbA1c < 8.0%
- Unwilling for SMBG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Benefits of a Painless Lancing Device Among Diabetes Subjects in Improving Self-monitoring Frequency and HbA1c
The purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and HbA1c compared to the conventional lancing device.
Read the detailed description
Self-monitoring of glucose forms the cornerstone of diabetes management. There are multiple limiting factors towards efficient self- monitoring of blood glucose, including cost barriers, inconvenience, investment of time, pain associated with pricking etc. Pain has perceived as a major impediment to the self-monitoring of blood glucose.
Genteel lancing device offers a painless pricking experience and hence helps to report blood sugar values at least 4 times a day. The perceived pain sensitivity of the study subjects would be assessed using the 4- point pain screening questionnaire during the course of the study.
The aim of this study is to gather information on the percentage reduction in HbA1c values in diabetes patients as compared to the baseline values after three months and six months respectively brought about by percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period. SMBG adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice weekly in type 2 subjects).
SMBG adherence can be provisionally attained by multiple pricking using painless Genteel lancing device compared to the conventional lancing device. Additionally, the subject is asked about the likelihood they would use the device if available for routine SMBG practice in the future.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Genteel lancing device, Conventional lancing device
- Keywords
- lancing device, HbA1c, painless lancing, SMBG adherence
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genteel lancing deviceDevice
Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively
Conventional lancing deviceDevice
Conventional lancing device
| Study group | Role | What they receive |
|---|---|---|
| Genteel arm | Experimental | In the Genteel arm, the subjects exclusively use the Genteel device for the first 12 weeks, and then switch to the conventional method of SMBG for an additional 12 weeks. This arm will use Butterfly Touch Lancets (BTL) throughout the study. Receives: Device: Genteel lancing device; Device: Conventional lancing device |
| Conventional arm | Active comparator | In the Conventional arm, the subjects use the conventional method of SMBG for the first 12 weeks and then switch to the Genteel device for an additional 12 weeks. This arm will use the lancet and lancing device which they were using prior to randomization to the study. Receives: Device: Genteel lancing device; Device: Conventional lancing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage SMBG adherence
Percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period.SMBG adherence = actual number of fingerpricks/ ideal number of fingerpricks(6 times daily in type 1 subjects or twice weekly in type 2 subjects). Should be assessed both at baseline and end of 24 weeks.
Measured: 24 weeks
Percentage reduction in HbA1c
- Percentage reduction in the HbA1c values as compared to the baseline values at 12 weeks and 24 weeks.
Measured: 24 weeks
Secondary outcomes (2)
Subjective assessment of pain reduction after using Genteel
The subject's Subjective Assessment of pain after using the Genteel device in comparison to conventional SMBG devices would be recorded using a pain scale.
The scale for pain sensation is as follows:
- Elimination
- Significant reduction
- Slight reduction
- No change
- Mild worsening of pain
- Significant worsening of pain
The above values are computed relative to the worst pain the subject can think of at a score of 6.
Measured: 24 weeks
Subjective assessment of probability of using Genteel for SMBG
The subject is asked about the likelihood they would use the device if available for routine SMBG practices in the future. Scale for predicting future (probability) use of device for SMBG is as follows:
- Definitely yes
- Probably yes
- Not sure
- Probably no
- Definitely no
The above values are computed relative to the worst probability this device would not be used in future at a score of 5.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start4 Feb 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
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 Type 1 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jothydev's Diabetes and Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jothydev Kesavadev, Jothydev's Diabetes and Research Centre
- Investigators
- Jothydev Kesavadev, MD, Principal investigator, Jothydev's Diabetes Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214704
- Sponsor's protocol ID
- JDC/GENTEEL/022/2019
- Status last verified
- Jul 2021
- First submitted
- 27 Dec 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
R. Warrier, S. Badarudeen, A. Shankar, G. Krishnan, L. Ramachandran, K. Thampiraj, S. Jothydev, J. Kesavadev. Assessing the Benefits of a Painless Lancing Device in a Subset of Patients Fearful of Finger Pricking. Diabetes Technol Ther. 2019. 21. A60-A61.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Benefits of a Painless Lancing Device Among Diabetes Subjects in Improving Self-monitoring Frequency and HbA1c
- ClinicalTrials.gov ID
- NCT04214704
- Acronym / sponsor ID
- JDC/GENTEEL/022/2019
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- lancing device, HbA1c, painless lancing, SMBG adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jothydev's Diabetes and Research CentreUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
The purpose of this study is to assess the benefits of a painless lancing device among diabetes subjects in improving self-monitoring frequency and HbA1c compared to the conventional lancing device.
Detailed description
Self-monitoring of glucose forms the cornerstone of diabetes management. There are multiple limiting factors towards efficient self- monitoring of blood glucose, including cost barriers, inconvenience, investment of time, pain associated with pricking etc. Pain has perceived as a major impediment to the self-monitoring of blood glucose.
Genteel lancing device offers a painless pricking experience and hence helps to report blood sugar values at least 4 times a day. The perceived pain sensitivity of the study subjects would be assessed using the 4- point pain screening questionnaire during the course of the study.
The aim of this study is to gather information on the percentage reduction in HbA1c values in diabetes patients as compared to the baseline values after three months and six months respectively brought about by percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period. SMBG adherence = actual number of fingerpricks (6 times daily in type 1 subjects or twice weekly in type 2 subjects).
SMBG adherence can be provisionally attained by multiple pricking using painless Genteel lancing device compared to the conventional lancing device. Additionally, the subject is asked about the likelihood they would use the device if available for routine SMBG practice in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genteel arm | Experimental | Device: Genteel lancing device, Device: Conventional lancing deviceIn the Genteel arm, the subjects exclusively use the Genteel device for the first 12 weeks, and then switch to the conventional method of SMBG for an additional 12 weeks. This arm will use Butterfly Touch Lancets (BTL) throughout the study. |
| Conventional arm | Active comparator | Device: Genteel lancing device, Device: Conventional lancing deviceIn the Conventional arm, the subjects use the conventional method of SMBG for the first 12 weeks and then switch to the Genteel device for an additional 12 weeks. This arm will use the lancet and lancing device which they were using prior to randomization to the study. |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Less than or equal to 70 years of age. If minor (<18 years), accompanied by caretaker.
- Diagnosed with either Type 1 or Type 2 diabetes including newly diagnosed. 50% of the study participants will be type 1 diabetes subjects and 50% will be type 2 diabetes subjects
- Presenting with an uncontrolled glycemic status (HbA1c >8.0%).
- Ready for Self-Monitoring of Blood Glucose (SMBG) practices.
- Attending physician prescribed testing at least 2 times per day
Key exclusion criteria (3 listed)
- More than 70 years and less than 5 years
- HbA1c < 8.0%
- Unwilling for SMBG.
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 |
|---|---|---|
| Genteel lancing devicePainless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively | Device | Conventional arm, Genteel arm |
| Conventional lancing deviceConventional lancing device | Device | Conventional arm, Genteel arm |
Primary outcome
Percentage SMBG adherence
Time frame: 24 weeks
Percentage SMBG adherence, defined as the percentage of total recorded SMBG values as compared to the ideal number of readings over the 24-week period.SMBG adherence = actual number of fingerpricks/ ideal number of fingerpricks(6 times daily in type 1 subjects or twice weekly in type 2 subjects). Should be assessed both at baseline and end of 24 weeks.
Percentage reduction in HbA1c
Time frame: 24 weeks
2) Percentage reduction in the HbA1c values as compared to the baseline values at 12 weeks and 24 weeks.
2 secondary outcomes
Subjective assessment of pain reduction after using Genteel
Time frame: 24 weeks
Subjective assessment of probability of using Genteel for SMBG
Time frame: 24 weeks
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 29 Jul 2021.
- Results publicationR. Warrier, S. Badarudeen, A. Shankar, G. Krishnan, L. Ramachandran, K. Thampiraj, S. Jothydev, J. Kesavadev. Assessing the Benefits of a Painless Lancing Device in a Subset of Patients Fearful of Finger Pricking. Diabetes Technol Ther. 2019. 21. A60-A61.
- Individual participant dataSharing planned: No
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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.
Jothydev Kesavadev, MD principal investigator
Jothydev's Diabetes Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genteel lancing device and Conventional lancing device in people with Type 1 Diabetes and Type 2 Diabetes, run by Jothydev's Diabetes and Research Centre at 1 site in India.
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 3 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 29 Jul 2021. 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 India. 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?
Percentage SMBG adherence (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT04214704, 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 29 Jul 2021.