Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: Genteel lancing device; Device: 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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Kerala
    • Trivandrum, Kerala, India, 695032
      • Jothydev's Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genteel arm; 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.	Device: Genteel lancing device; Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively; Device: Conventional lancing device; Conventional lancing device
Active Comparator: Conventional arm; 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.	Device: Genteel lancing device; Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively; Device: Conventional lancing device; Conventional lancing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jothydev's Diabetes and Research Centre
• Investigators: Principal Investigator: Jothydev Kesavadev, MD, Jothydev's Diabetes Research Center

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: HbA1c; lancing device; painless lancing; SMBG adherence
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: JDC/GENTEEL/022/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes