New treatment option for Type 2 Diabetes
Official title Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
ClinicalTrials.gov ID: NCT05884775
What this study is testing
- What it's testing
- Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PCP Group:
- Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
- Provide care to at least five patients with a diagnosis of T2D Patient Group:
- Have a diagnosis of T2D for ≥6 months;
- Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year;
You likely can't join if
- Patient Group:
- Refuse or are unable to provide informed consent;
- Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in...
- Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
- Are pregnant or planning to become pregnant within 12 months;
- Currently participate in another T2D study; or
See the full eligibility criteria
- PCP Group:
- Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
- Provide care to at least five patients with a diagnosis of T2D Patient Group:
- Have a diagnosis of T2D for ≥6 months;
- Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year;
- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be \> 18 years of age.
- Patient Group:
- Refuse or are unable to provide informed consent;
- Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR;
- Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
- Are pregnant or planning to become pregnant within 12 months;
- Currently participate in another T2D study; or
- Plan to discontinue care at the clinic within the next 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.