Type 2 DiabetesNCT07743307
Feasibility of a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
A study testing The DECIDE Self-Management Program and Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if combining a virtual diabetes self-management program (DECIDE®) with continuous glucose monitoring (CGM) is practical and well-received by adults with type 2 diabetes. Twenty participants will attend the 9-week, virtual DECIDE Self-Management Program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- The DECIDE Self-Management Program and Continuous Glucose Monitoring (CGM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Diagnosis of type 2 diabetes
- Suboptimal hemoglobin A1C (8.0% or greater) based on a laboratory result in the past 3 months
- Access to and capability of using a smart cellular device
- Smart cellular device compatible with the Freestyle Libre CGM smartphone application
- Capable of giving informed consent
Who cannot join
- Currently using CGM
- Non-English speaking
- Unavailable to attend the virtual DECIDE group
- Unavailable for follow-up
- Currently pregnant
- Currently on dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examining the Feasibility of Pairing a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
The purpose of this study is to determine if combining a virtual diabetes self-management program (DECIDE®) with continuous glucose monitoring (CGM) is practical and well-received by adults with type 2 diabetes. Twenty participants will attend the 9-week, virtual DECIDE Self-Management Program. They will receive CGM sensors to wear during the 22-week study to track their blood sugar. Participants will complete questionnaires at three time points -- at baseline, 1 week after the DECIDE Program ends, and 3 months after the DECIDE Program ends. They will also complete a blood draw to measure hemoglobin A1C at baseline and 3 months after the intervention ends. Additionally, they will complete a brief interview after the program ends to gather insights into participants' experiences with the program. The study aims to examine whether this integrated approach will be both feasible and acceptable, potentially leading to better diabetes management and improved health outcomes.
Read the detailed description
The overall objective of this project is to pilot and evaluate the feasibility and acceptability of an intervention that combines CGM with a virtually delivered, research-tested diabetes self-management program called DECIDE®, delivered over 9 weeks. We will recruit 20 adults with type 2 diabetes who receive care at Northwell Health, the largest healthcare provider in New York state. Participants will receive the 9-week DECIDE Program as well as CGM sensors to wear during the full 22-week study. Participants will be asked to complete questionnaires to assess diabetes distress, health-related problem-solving, diabetes knowledge, and diabetes self-management behaviors at baseline, 1-week post-intervention, and 3-months post-intervention. They will complete a home blood draw at baseline and 3-months post-intervention. And they will complete a qualitative interview at 1-week post-intervention to assess the acceptability of the intervention. Data related to feasibility will be collected throughout (e.g., rates of recruitment and retention, DECIDE session completion, CGM initiation, and CGM maintenance).
The aims of this study are: 1) to determine the feasibility and acceptability of an intervention pairing DECIDE with CGMs and 2) to explore change in diabetes clinical and behavioral factors between the start of the study and 3 months after the intervention ends.
This work will lead to the development of an accessible, acceptable, and usable intervention that has the potential to provide diabetes self-management support virtually, augmented by CGM, to improve diabetes outcomes for people with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- The DECIDE Self-Management Program, Continuous Glucose Monitoring (CGM)
- Keywords
- Type 2 diabetes, Continuous glucose monitoring, Diabetes self-management, Behavioral intervention
- 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.
The DECIDE Self-Management ProgramBehavioural
DECIDE is an evidence-based diabetes self-management support program that uses problem-solving skills training to educate and empower individuals in managing their diabetes. For this study, it has been adapted to include education and support around CGM use. The program will be delivered virtually by a trained facilitator over 9 weeks.
Continuous Glucose Monitoring (CGM)Behavioural
Participants will be provided Freestyle Libre CGM sensors to wear during the intervention and follow-up periods (up to 22 weeks). CGM includes a small sensor attached to the arm that provides real-time glucose data by connecting via Bluetooth to an application on a smartphone. The sensor will be replaced every 2 weeks, and participants will be able to see their glucose values on their personal smartphone device.
| Study group | Role | What they receive |
|---|---|---|
| DECIDE Self-Management Program + CGM | Experimental | Participants will receive:
1. The 9-week, virtually delivered DECIDE Self-Management Program.
2. Continuous glucose monitoring (CGM) sensors Receives: Behavioral: The DECIDE Self-Management Program; Behavioral: Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Feasibility will be assessed as identification of the eligible patient population in the EHR, study recruitment and retention rates, DECIDE enrollment and session completion rates, and CGM initiation and maintenance rates.
Measured: These outcomes will be monitored continuously throughout study completion, approximately 6 months
Acceptability of the intervention
Acceptability will be assessed by brief interviews with the 20 participants to obtain perspectives on the acceptability of the implementation as well as the intervention and its components (DECIDE Program; CGM initiation and engagement).
Measured: 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start31 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-arm design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743307
- Sponsor's protocol ID
- 26-0258
- Other IDs
- 5P30DK111022, CDTR-1313
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility of Pairing a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07743307
- Acronym / sponsor ID
- 26-0258
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Continuous glucose monitoring, Diabetes self-management, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Albert Einstein College of Medicine
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if combining a virtual diabetes self-management program (DECIDE®) with continuous glucose monitoring (CGM) is practical and well-received by adults with type 2 diabetes. Twenty participants will attend the 9-week, virtual DECIDE Self-Management Program. They will receive CGM sensors to wear during the 22-week study to track their blood sugar. Participants will complete questionnaires at three time points -- at baseline, 1 week after the DECIDE Program ends, and 3 months after the DECIDE Program ends. They will also complete a blood draw to measure hemoglobin A1C at baseline and 3 months after the intervention ends. Additionally, they will complete a brief interview after the program ends to gather insights into participants' experiences with the program. The study aims to examine whether this integrated approach will be both feasible and acceptable, potentially leading to better diabetes management and improved health outcomes.
Detailed description
The overall objective of this project is to pilot and evaluate the feasibility and acceptability of an intervention that combines CGM with a virtually delivered, research-tested diabetes self-management program called DECIDE®, delivered over 9 weeks. We will recruit 20 adults with type 2 diabetes who receive care at Northwell Health, the largest healthcare provider in New York state. Participants will receive the 9-week DECIDE Program as well as CGM sensors to wear during the full 22-week study. Participants will be asked to complete questionnaires to assess diabetes distress, health-related problem-solving, diabetes knowledge, and diabetes self-management behaviors at baseline, 1-week post-intervention, and 3-months post-intervention. They will complete a home blood draw at baseline and 3-months post-intervention. And they will complete a qualitative interview at 1-week post-intervention to assess the acceptability of the intervention. Data related to feasibility will be collected throughout (e.g., rates of recruitment and retention, DECIDE session completion, CGM initiation, and CGM maintenance).
The aims of this study are: 1) to determine the feasibility and acceptability of an intervention pairing DECIDE with CGMs and 2) to explore change in diabetes clinical and behavioral factors between the start of the study and 3 months after the intervention ends.
This work will lead to the development of an accessible, acceptable, and usable intervention that has the potential to provide diabetes self-management support virtually, augmented by CGM, to improve diabetes outcomes for people with type 2 diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-arm design
| Arm | Type | Receives |
|---|---|---|
| DECIDE Self-Management Program + CGM | Experimental | Behavioral: The DECIDE Self-Management Program, Behavioral: Continuous Glucose Monitoring (CGM)Participants will receive: 1. The 9-week, virtually delivered DECIDE Self-Management Program. 2. Continuous glucose monitoring (CGM) sensors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Diagnosis of type 2 diabetes
- Suboptimal hemoglobin A1C (8.0% or greater) based on a laboratory result in the past 3 months
- Access to and capability of using a smart cellular device
- Smart cellular device compatible with the Freestyle Libre CGM smartphone application
Key exclusion criteria (6 listed)
- Currently using CGM
- Non-English speaking
- Unavailable to attend the virtual DECIDE group
- Unavailable for follow-up
- Currently pregnant
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 |
|---|---|---|
| The DECIDE Self-Management ProgramDECIDE is an evidence-based diabetes self-management support program that uses problem-solving skills training to educate and empower individuals in managing their diabetes. For this study, it has been adapted to include education and support around CGM use. The program will be delivered virtually by a trained facilitator over 9 weeks. | Behavioural | DECIDE Self-Management Program + CGM |
| Continuous Glucose Monitoring (CGM)Participants will be provided Freestyle Libre CGM sensors to wear during the intervention and follow-up periods (up to 22 weeks). CGM includes a small sensor attached to the arm that provides real-time glucose data by connecting via Bluetooth to an application on a smartphone. The sensor will be replaced every 2 weeks, and participants will be able to see their glucose values on their personal smartphone device. | Behavioural | DECIDE Self-Management Program + CGM |
Primary outcome
Feasibility of the intervention
Time frame: These outcomes will be monitored continuously throughout study completion, approximately 6 months
Feasibility will be assessed as identification of the eligible patient population in the EHR, study recruitment and retention rates, DECIDE enrollment and session completion rates, and CGM initiation and maintenance rates.
Acceptability of the intervention
Time frame: 1-week post-intervention
Acceptability will be assessed by brief interviews with the 20 participants to obtain perspectives on the acceptability of the implementation as well as the intervention and its components (DECIDE Program; CGM initiation and engagement).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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.
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 The DECIDE Self-Management Program and Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by Northwell Health 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of the intervention (time frame: These outcomes will be monitored continuously throughout study completion, approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.