Clinical trial NCT04214704: Assessing the Benefits of a Painless Lancing Device Among Diabetes Patients
Official title: Assessing the Benefits of a Painless Lancing Device Among Diabetes Subjects in Improving Self-monitoring Frequency and HbA1c
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: lancing device
HbA1c
painless lancing
SMBG adherence
Lead sponsor: Jothydev's Diabetes and Research Centre
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage SMBG adherence
timeFrame: 24 weeks
measure: Percentage reduction in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Subjective assessment of pain reduction after using Genteel
timeFrame: 24 weeks
measure: Subjective assessment of probability of using Genteel for SMBG
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Trivandrum
country: India
facility: Jothydev's Diabetes Research Center
state: Kerala
Study officials:
affiliation: Jothydev's Diabetes Research Center
name: Jothydev Kesavadev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.