study for Indian Diabetes Management using Accu-Chek Instant system and mySugr Mobile Application in type 2 Diabetes

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2021/12/038660
• Lead Sponsor: Roche Diabetes Care India Pvt Ltd

Brief Summary

This is a single-arm, open-label, prospective, multicenter, real-world evidencestudy.DocuSign Envelope ID: 3AB43F0F-3DA3-4113-98C5-035999065777CONFIDENTIAL 2021-04-23\_CIP\_V 2.0\_DC000092 page 17 of 49InternalA total of 982 patients with T2DM with suboptimal glycemic control on insulin therapy with or without oral anti-diabetic medications will be enrolled in the study. The duration of study for each participant will be approximately 24 weeks (6 months). During a routine consultation, subjects will be recruited as per the inclusion and exclusion criteria.

Main aim of this study is to demonstrate that a teambased care approach, coupled with self-monitoring of blood glucose (SMBG) practices using Accu-Chek Instant System and mySugr app can ensure continuing education and promote behavioral changes that can help patients attain recommended glycemic targets.

Primary:  Patient related outcomes (PROs)– Changes in diabetes distress using Problem Area in Diabetes (PAID-20)

scoreSecondary: ï‚· The Diabetes Medication System Rating Questionnaire (DMRSQ)ï‚· % of measurements in Rangeï‚· Hypoglycemia frequencyï‚· Low Blood Glucose Indexï‚· High Blood Glucose Index

There will be Four visits in total: ï‚· V1 (Screening/Baseline)o Screening: -14 to day 0o Baseline: Day 0ï‚· V2: Follow-up at 4 weeks (Can be a virtual consultation depending on the current situation)ï‚· V3: Follow-up at 12 weeks (Can be a virtual consultation depending on the current situation) ï‚· V4: Follow-up at 24 week plus unscheduled visits as required.  Duration of subject is approximately 24 weeks after enrolment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Subject has provided his/her signed informed consent to participate in the study.
• Subject is ≥ 18 years of age Subject is diagnosed with diabetes type 2 and currently on anti-diabetic therapy ± insulin.
• Subjects most recent HbA1c is above 8% (measured within the last 3 months at local laboratory).
• Subjects who can read and write in English language and can use smartphone.
• Subject willing to comply with study procedures.

Exclusion Criteria

• Subject who has been diagnosed with any clinically significant conditions like infectious disease, major organ system disease such as gastroparesis or renal disease, psychosis or cognitive impairment), at investigator’s discretion will be excluded.
• Subject who are on chemotherapy and/or radiation therapy (self-reported) will not be considered for this study.
• Pregnant or lactating women will be excluded from the study.
• Subject using any other mobile device to monitor blood glucose levels will be excluded.
• Subject addicted to alcohol or other substance of abuse as assessed by the investigator will be excluded.
• Subject using any other mobile device to monitor glucose levels will be excluded.
• Subject with serious or unstable physical or psychological condition rendering the subject unable to understand the nature and the scope of the study and to follow the study the study procedures will be excluded.
• Subject with a significant manifestation of severe diabetes related long-term complications e.g., severe retinopathy, neuropathy, nephropathy requiring dialysis will not be included.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary - Patient related outcomes PROs– Changes in	Baseline | Follow up Visit 3- Week 12 | EOS Visit 4- Week 24
diabetes distress using Problem Area in Diabetes	Baseline | Follow up Visit 3- Week 12 | EOS Visit 4- Week 24
PAID-20 score	Baseline | Follow up Visit 3- Week 12 | EOS Visit 4- Week 24

Secondary Outcome Measures

Name	Time	Method
ï‚· The Diabetes Medication System Rating	Questionnaire (DMRSQ)

Trial Locations

Locations (3)

Center for Diabetes & Endocrine Care; 🇮🇳 Bangalore, KARNATAKA, India

Diabetes-Obesity-Thyroid-Hormone Clinic; 🇮🇳 Kolkata, WEST BENGAL, India

Magna Centres for Obesity Diabetes and Endocrinology; 🇮🇳 Bangalore, KARNATAKA, India

Center for Diabetes & Endocrine Care

🇮🇳Bangalore, KARNATAKA, India

Dr K M Prasanna Kumar

Principal investigator

9845156811

dr.kmpk@gmail.com