| CTRI Number |
CTRI/2021/12/038660 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
study for Indian Diabetes Management using Accu-Chek Instant system and mySugr Mobile Application in type 2 Diabetes |
|
Scientific Title of Study
|
An Indian Evidence on integrated Personalized Diabetes Management using Accu-Chek Instant system and mySugr Mobile Application in type 2 Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DC000092 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
Lead Invetigator |
| Affiliation |
Dr Mohans Diabetes Specialities Centre Pvt Ltd |
| Address |
No 6 B Conran Smith Road Gopala Puram
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Khatri |
| Designation |
Head Medical and Scientific Affairs |
| Affiliation |
Roche Diabetes Care India Pvt Ltd |
| Address |
Roche Diabetes Care India Pvt Ltd, 146 B, 166A, Unit No. 7, 8, 9 8th Floor, R city office, R city Mall, Lal Bahadur Shashtri Marg, Ghatkopar
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
|
| Fax |
|
| Email |
varsha.khatry@roche.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Khatri |
| Designation |
Head Medical and Scientific Affairs |
| Affiliation |
Roche Diabetes Care India Pvt Ltd |
| Address |
Roche Diabetes Care India Pvt Ltd, 146 B, 166A, Unit No. 7, 8, 9 8th Floor, R city office, R city Mall, Lal Bahadur Shashtri Marg, Ghatkopar
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
|
| Fax |
|
| Email |
varsha.khatry@roche.com |
|
|
Source of Monetary or Material Support
|
| Roche Diabetes Care India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Roche Diabetes Care India Pvt Ltd |
| Address |
146 B, 166A, Unit No. 7, 8, 9 8th Floor, R city office, R city Mall, Lal Bahadur Shashtri Marg, Ghatkopar, Mumbai Suburban-400086 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K M Prasanna Kumar |
Center for Diabetes & Endocrine Care |
410A,Consultation room, Department of Endocrinology and Diabetology, 1st Floor, 1st stage,3rd Block, Near BDA Complex,
HBR Layout, Bengaluru, Karnataka 560043
Bangalore
KARNATAKA |
9845156811
dr.kmpk@gmail.com |
| Dr Anirban Majumdar |
Diabetes-Obesity-Thyroid-Hormone Clinic |
26A, Flat GB, Consultation room, Ground floor, Chhayaneer, Gariahat Rd S, behind Narendra Seva Trust Clinic, Dhakuria, Selimpur, Jodhpur Park, Kolkata, West Bengal 700031
Kolkata
WEST BENGAL |
9830078837
dranirbanmazumdar@gmail.com |
| Dr Ananthraman R |
Magna Centres for Obesity Diabetes and Endocrinology |
Bus Depot, Sai Manasa Building, #703, Room no.1, 1st Floor, Department of Endocrinology and Diabetology, 30th Main Rd, near Kuvempu Nagar, BTM 2nd Stage, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA |
9632359850
anantharaman1979@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary - Patient related outcomes PROs– Changes in
diabetes distress using Problem Area in Diabetes
PAID-20 score
|
Baseline
Follow up Visit 3- Week 12
EOS Visit 4- Week 24
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ï‚· The Diabetes Medication System Rating
Questionnaire (DMRSQ)
ï‚· % of measurements in Range
ï‚· Hypoglycemia frequency
ï‚· Low Blood Glucose Index
ï‚· High Blood Glucose Index |
Baseline
Follow up visit 2- Week 4
Follow up Visit 3- Week 12
EOS Visit 4- Week 24
Unscheduled visit |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-arm, open-label, prospective, multicenter, real-world evidence
study.
DocuSign Envelope ID: 3AB43F0F-3DA3-4113-98C5-035999065777
CONFIDENTIAL
2021-04-23_CIP_V 2.0_DC000092 page 17 of 49
Internal
A 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) score
Secondary:
ï‚· The Diabetes Medication System Rating
Questionnaire (DMRSQ)
ï‚· % of measurements in Range
ï‚· Hypoglycemia frequency
ï‚· Low Blood Glucose Index
ï‚· High Blood Glucose Index There will be Four visits in total:
ï‚· V1 (Screening/Baseline)
o Screening: -14 to day 0
o Baseline: Day 0
ï‚· 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.
|