NCT04214704

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 4, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

December 27, 2019

Last Update Submit

July 28, 2021

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

lancing deviceHbA1cpainless lancingSMBG adherence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Subjective assessment of pain reduction after using Genteel

    24 weeks

  • Subjective assessment of probability of using Genteel for SMBG

    24 weeks

Study Arms (2)

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.

Device: Genteel lancing deviceDevice: 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.

Device: Genteel lancing deviceDevice: Conventional lancing device

Interventions

Genteel lancing deviceDEVICE

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

Conventional armGenteel arm
Conventional lancing deviceDEVICE

Conventional lancing device

Conventional armGenteel arm

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jothydev's Diabetes Research Center

Trivandrum, Kerala, 695032, India

Location

Related 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.

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jothydev Kesavadev, MD

    Jothydev's Diabetes Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Diabetologist and Chairman

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 2, 2020

Study Start

February 4, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)