Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients

Type 2 Diabetes Clinical Trial

Official title:

Assessing the Benefits of a Painless Lancing Device Among Diabetes Subjects in Improving Self-monitoring Frequency and HbA1c

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214704
• Other study ID #: JDC/GENTEEL/022/2019
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2021
• Source: Jothydev's Diabetes and Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Less than or equal to 70 years of age. If minor (<18 years), accompanied by caretaker.

2. 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

3. Presenting with an uncontrolled glycemic status (HbA1c >8.0%).

4. Ready for Self-Monitoring of Blood Glucose (SMBG) practices.

5. Attending physician prescribed testing at least 2 times per day

6. 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.

Exclusion Criteria:

1. More than 70 years and less than 5 years

2. HbA1c < 8.0%

3. Unwilling for SMBG.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• Genteel lancing device
Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively
• Conventional lancing device
Conventional lancing device

Locations

Country	Name	City	State
India	Jothydev's Diabetes Research Center	Trivandrum	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jothydev's Diabetes and Research Centre

Country where clinical trial is conducted

India, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks
Primary	Percentage reduction in HbA1c	2) Percentage reduction in the HbA1c values as compared to the baseline values at 12 weeks and 24 weeks.	24 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks