Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2
Brief 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 intervention.
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.
Interventions
BEHAVIORALtherapy regimen
Subjects will be recommend changes in therapy regimens.
Sponsors
Medtronic
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years to ≤ 70 years of age 2. 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 3. Subject's A1C \> 8.0% to ≤ 10% conducted in the last 4 weeks 4. Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC) 5. Subject is willing to comply with the study procedures
Exclusion criteria
1. Subject is unable to tolerate tape adhesive in the area of sensor placement 2. Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion. 3. Subject has no experience with SMBG and blood glucose meter use 4. Subject has undergone an iPro evaluation during the past 6 months 5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) 6. 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 7. 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 8. Subject has unresolved alcohol or drug addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in A1C at 3 Months | 3 months | Descriptive analysis of change in A1C from baseline to end of 3-month study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Device Effects (SADE). | 3 months | Evaluation of incidence of SADE during the study. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iPro2 Use All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests | 181 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Screening Failure | 1 |
| Overall Study | Subject missed visit 3,4, came in for V5 | 1 |
| Overall Study | Withdrawal by Investigator | 15 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | iPro2 Use |
|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 10.06 |
| Region of Enrollment India | 181 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 181 |
| other Total, other adverse events | 5 / 181 |
| serious Total, serious adverse events | 0 / 181 |
Outcome results
Primary
Change From Baseline in A1C at 3 Months
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Time frame: 3 months
Population: 181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iPro2 Use | Change From Baseline in A1C at 3 Months | -0.6 percent | Standard Deviation 1.11 |
Secondary
Number of Serious Adverse Device Effects (SADE).
Evaluation of incidence of SADE during the study.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iPro2 Use | Number of Serious Adverse Device Effects (SADE). | 0 events |