Diabetes Mellitus, Type 2NCT01995539

Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

A study testing therapy regimen in people with Diabetes Mellitus, Type 2, run by Medtronic MiniMed, Inc. at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients in India with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: therapy regimen
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 11 sitesIndia
Study dates: Dec 2012to Apr 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is > 18 years to ≤ 70 years of age
Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin
Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks
Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
Subject is willing to comply with the study procedures

Who cannot join

Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
Subject has no experience with SMBG and blood glucose meter use
Subject has undergone an iPro evaluation during the past 6 months
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
Subject has unresolved alcohol or drug addiction

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

India11 sites

DIA Care
Ahmedabad, Gujarat, 380015
M.V Hospital for Diabetes Research centre
Chennai, Tamil Nadu, 600013
Madras Diabetes Research Foundation
Gopālapuram, Chennai, 600086
Medanta
Gurgaon, Haryana, 122 001
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
K.G.N Diabetes and Endocrine Centre
Mumbai, Maharashtra, 400008
Lina Diabetes Care Centre
Mumbai, Maharashtra, 400053
Dr.Kovil's Diabetes Care centre
Mumbai, Maharashtra, 400058
Diab Care Center
Mumbai, Maharashtra, 400080
Diabetes Care & Research Center
Pune, Maharashtra, 411011
Jothydev's Diabetes and Research Centre
Trivandrum, Kerala, 695032

Other trials in India

About this study

Read the detailed description

The study will be designed to demonstrate the value of iPro2 in real-world diabetes management in type 2 patients in India. It will be an interventional post-market, prospective, multi-center study with a data review performed after 30 subjects have completed the trial.

During the course of the study, patients will undergo two iPro2 evaluations:

First iPro2 test (Visit 1 [application] \& 2 [removal])
Second iPro2 test (Visit 3 [application] \& 4 [removal])

Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These questionnaires aim to assess the impact of an iPro2 evaluation on the physicians understanding of their patient's metabolic fluctuations and its support of therapeutic interventions. They will also investigate the subjects understanding (both pre \& post iPro2 evaluation) of the concept of glycemic variability and the importance of compliance to HCP recommendations.

Conditions: Diabetes Mellitus, Type 2
Being tested: therapy regimen
Keywords: Type 2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

therapy regimenBehavioural
Subjects will be recommend changes in therapy regimens.

Study groups in NCT01995539
Study group	Role	What they receive
iPro2 Use	Experimental	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests Receives: Behavioral: therapy regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in A1C at 3 Months
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Measured: 3 months

Secondary outcomes (1)

Number of Serious Adverse Device Effects (SADE).
Evaluation of incidence of SADE during the study.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Apr 2014

First posted26 Nov 2013 (estimated)
Study startDec 2012
Primary completionJan 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01995539
Sponsor's protocol ID: CEP274
Status last verified: Nov 2018
First submitted: 8 Nov 2013
Last updated: 4 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
ClinicalTrials.gov ID: NCT01995539
Acronym / sponsor ID: CEP274
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: Dec 2012
Primary completion: Jan 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 18 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

During the course of the study, patients will undergo two iPro2 evaluations:

First iPro2 test (Visit 1 [application] \& 2 [removal])
Second iPro2 test (Visit 3 [application] \& 4 [removal])

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iPro2 Use	Experimental	Behavioral: therapy regimenAll subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is > 18 years to ≤ 70 years of age
Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin
Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks
Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
Subject is willing to comply with the study procedures

Key exclusion criteria (8 listed)

Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
Subject has no experience with SMBG and blood glucose meter use
Subject has undergone an iPro evaluation during the past 6 months
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
therapy regimenSubjects will be recommend changes in therapy regimens.	Behavioural	iPro2 Use

Primary outcome

Change From Baseline in A1C at 3 Months
Time frame: 3 months
Descriptive analysis of change in A1C from baseline to end of 3-month study period

1 secondary outcome

Number of Serious Adverse Device Effects (SADE).
Time frame: 3 months

Results and safety

Results posted to the registry on 18 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iPro2 Use	181	148

Primary outcome: Change From Baseline in A1C at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: percent

Measure	iPro2 Use n = 148
Value	-0.6 (1.11)

Population analysed: 181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 Month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iPro2 Use	0 of 181 (0%)	5 of 181 (2.8%)	0 of 181

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jothydev Kesavadev, MD principal investigator

Jothydev's Diabetes and Research Centre

Mohan V, MD principal investigator

Madras Diabetes Research Foundation

Vijay Viswanathan, MD principal investigator

M.V Hospital for Diabetes Research centre

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing therapy regimen in people with Diabetes Mellitus, Type 2, run by Medtronic MiniMed, Inc. at 11 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in A1C at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.