Diabetes Mellitus, Type 2REINFORCENCT04473326
Reinforcement Learning in Diabetes Mellitus Trial
A study testing Reinforcement Learning in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Medication Adherence
- What is being tested?
- Reinforcement Learning
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 28 Jan 2022
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-84 years
- Diagnosed with type 2 diabetes mellitus (T2DM) and are prescribed between 1-3 daily oral medications for this disease
- Currently have a smartphone with a data plan or WiFi at home
- HbA1c level ≥7.5%
- Basic working knowledge of English
- Willing and able to set up the platform and adhere to study procedures
- Either not currently using a pillbox or willing to use electronic pill bottles (EDMs) for diabetes medications for the duration of the study
Who cannot join
- Patients with active enrollment in another diabetes trial within Mass General Brigham
- Patients who receive daily assistance with taking their medications at home
- Patients who are unable to receive text messages for more than 3 days in a row during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Optimizing Message Framing for Healthy Habits for Patients With Type 2 Diabetes - Phase II (Pragmatic Trial)
Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. Type 2 diabetes is an optimal condition in which to test this program, as it is one of the most prevalent chronic conditions in the US adult population and requires most patients to be on daily or twice daily doses of medications. This pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.
Read the detailed description
The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. This pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: 1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment response patterns, or 2) a control arm with up to daily, untailored text messages. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.
- Conditions
- Diabetes Mellitus, Type 2, Medication Adherence
- Being tested
- Reinforcement Learning
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement LearningBehavioural
Participants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant.
| Study group | Role | What they receive |
|---|---|---|
| Reinforcement Learning Intervention Arm | Experimental | Up to daily, tailored text messages. Receives: Behavioral: Reinforcement Learning |
| Control Arm | No intervention | Up to daily, untailored text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication adherence to type 2 diabetes oral medications (averaged) as measured by the number of dates and times of pillbottle openings in the electronic pill bottles
Measured: 6 months
Secondary outcomes (1)
Glycemic Control
Change in glycated hemoglobin A1c from baseline to end of the 6-month follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start4 Feb 2021
- Primary completion4 Jan 2022
- Study completion28 Jan 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473326
- Sponsor's protocol ID
- 2020P000846
- Other IDs
- P30AG064199-01
- Acronym
- REINFORCE
- Status last verified
- Feb 2023
- First submitted
- 13 Jul 2020
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lauffenburger JC, Yom-Tov E, Keller PA, McDonnell ME, Bessette LG, Fontanet CP, Sears ES, Kim E, Hanken K, Buckley JJ, Barlev RA, Haff N, Choudhry NK. REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): study protocol of a pragmatic randomised trial. BMJ Open. 2021 Dec 3;11(12):e052091. doi: 10.1136/bmjopen-2021-052091.
PubMed 34862289
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Message Framing for Healthy Habits for Patients With Type 2 Diabetes - Phase II (Pragmatic Trial)
- ClinicalTrials.gov ID
- NCT04473326
- Acronym / sponsor ID
- REINFORCE / 2020P000846
- Conditions
- Diabetes Mellitus, Type 2, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. Type 2 diabetes is an optimal condition in which to test this program, as it is one of the most prevalent chronic conditions in the US adult population and requires most patients to be on daily or twice daily doses of medications. This pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.
Detailed description
The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced text messaging program to support medication adherence in patients with type 2 diabetes. This pilot study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: 1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment response patterns, or 2) a control arm with up to daily, untailored text messages. Our outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforcement Learning Intervention Arm | Experimental | Behavioral: Reinforcement LearningUp to daily, tailored text messages. |
| Control Arm | No intervention | –Up to daily, untailored text messages. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18-84 years
- Diagnosed with type 2 diabetes mellitus (T2DM) and are prescribed between 1-3 daily oral medications for this disease
- Currently have a smartphone with a data plan or WiFi at home
- HbA1c level ≥7.5%
- Basic working knowledge of English
Key exclusion criteria (3 listed)
- Patients with active enrollment in another diabetes trial within Mass General Brigham
- Patients who receive daily assistance with taking their medications at home
- Patients who are unable to receive text messages for more than 3 days in a row during the study period
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 |
|---|---|---|
| Reinforcement LearningParticipants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant. | Behavioural | Reinforcement Learning Intervention Arm |
Primary outcome
Medication Adherence
Time frame: 6 months
Medication adherence to type 2 diabetes oral medications (averaged) as measured by the number of dates and times of pillbottle openings in the electronic pill bottles
1 secondary outcome
Glycemic Control
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34862289Lauffenburger JC, Yom-Tov E, Keller PA, McDonnell ME, Bessette LG, Fontanet CP, Sears ES, Kim E, Hanken K, Buckley JJ, Barlev RA, Haff N, Choudhry NK. REinforcement learning to improve non-adherence for diabetes treatments by Optimising Response and Customising Engagement (REINFORCE): study protocol of a pragmatic randomised trial. BMJ Open. 2021 Dec 3;11(12):e052091. doi: 10.1136/bmjopen-2021-052091.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcement Learning in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Brigham and Women's Hospital at 1 site in United States.
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 7 inclusion and 3 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 8 Feb 2023). 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?
Medication Adherence (time frame: 6 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 NCT04473326, which also lists 1 linked publication.
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 8 Feb 2023.