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Completed

NCT Number: NCT04214704

Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

5 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jothydev's Diabetes Research Center

Trivandrum, Kerala, 695032, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • More than 70 years and less than 5 years
  • HbA1c < 8.0%
  • Unwilling for SMBG.

Treatment and study plan

Genteel lancing device

Device

Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively

Conventional lancing device

Device

Conventional lancing device

Primary outcomes

  1. 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.

  2. Percentage reduction in HbA1c

    Time frame: 24 weeks

    • Percentage reduction in the HbA1c values as compared to the baseline values at 12 weeks and 24 weeks.

Secondary outcomes

  1. Subjective assessment of pain reduction after using Genteel

    Time frame: 24 weeks

    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.

  2. Subjective assessment of probability of using Genteel for SMBG

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Jothydev's Diabetes and Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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