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Behavioral Intervention
Personalized Text Messaging for Type 2 Diabetes (REINFORCE2 Trial)
N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Prescribed between 1-3 daily oral medications for diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if personalized text messages can help people with type 2 diabetes take their meds, with the goal of improving health outcomes.
Who is the study for?
This trial is for adults aged 18-84 with type 2 diabetes who have a recent HbA1c level of at least 7.5%, use a smartphone, understand English or Spanish, take 1-3 daily oral diabetes meds, and have been less than ideally consistent with their medication (PDC <0.80). It's not for those getting daily help with meds or unwilling to switch to electronic pill bottles.
What is being tested?
The study tests if personalized text messages based on reinforcement learning can improve medication adherence in type 2 diabetes patients compared to standard texts. Participants will be randomly assigned to receive either tailored messages that adapt over time or generic ones, both potentially up to daily.
What are the potential side effects?
Since the intervention involves only behavioral messaging via text and does not include medications or medical procedures, there are no direct physical side effects expected from participating in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes.
Select...
I take 1 to 3 pills daily for my diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diabetes medication adherence
Secondary study objectives
Glycemic control
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Reinforcement Learning Intervention ArmExperimental Treatment1 Intervention
Up to daily, tailored text messages.
Group II: Control ArmActive Control1 Intervention
Up to daily, untailored text messages.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reinforcement Learning
2021
N/A
~60
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,839 Total Patients Enrolled
27 Trials studying Diabetes
767,049 Patients Enrolled for Diabetes
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,206 Total Patients Enrolled
31 Trials studying Diabetes
1,979,905 Patients Enrolled for Diabetes
Boston Medical CenterOTHER
405 Previous Clinical Trials
884,901 Total Patients Enrolled
4 Trials studying Diabetes
683 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Type 2 Diabetes.I take 1 to 3 pills daily for my diabetes.Your most recent HbA1c level is 7.5% or higher.You have not been taking your medication regularly, as shown by your prescription records.
Research Study Groups:
This trial has the following groups:- Group 1: Reinforcement Learning Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.