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NCT Number: NCT07743307

Feasibility of 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Heath

Manhasset, New York, 11030, United States

Location contact

Elizabeth A Vrany, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Currently using CGM
  • Non-English speaking
  • Unavailable to attend the virtual DECIDE group
  • Unavailable for follow-up
  • Currently pregnant
  • Currently on dialysis

Treatment and study plan

The DECIDE Self-Management Program

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

Other outcomes

  1. Hemoglobin A1C

    Time frame: baseline and 3-months post-intervention

    HbA1c will be assessed at baseline and 3-months post-intervention. A phlebotomist will travel to participants' homes to conduct blood draws, and the sample will be transported to and processed by Northwell Health Labs. Standard laboratory assays will be conducted by Northwell Health Labs.

  2. CGM Time in Range

    Time frame: Time in range will be measured continuously during the 22-week study period. Average time in range will be computed during the 2 weeks immediately post-intervention and two weeks preceding the 3-months post-intervention timepoint.

    Blood glucose levels will be measured continuously using the CGM during the 22-week study period. Raw glucose data and summary reports will be obtained from LibreView. Time in range will be computed as the percent of time that a person spends with their blood glucose levels in the target range of 70-180 mg/dL

  3. Diabetes distress

    Time frame: baseline; 1-week post-intervention; 3-months post-intervention

    Diabetes distress will be assessed using the Diabetes Distress Scale-17 (DSS-17), a valid and reliable 17-item measure that assesses emotional distress in the setting of diabetes. A total score is computed at each timepoint by averaging all items.

  4. Health-related problem solving

    Time frame: baseline; 1-week post-intervention; 3-months post-intervention

    Health-related problem solving will be assessed using the Health Problem-Solving Scale Rational Problem-Solving Subscale (HPSS-RPS), a valid and reliable measure assessing health-related problem solving. The RPS subscale score will be computed at each timepoint.

  5. Diabetes knowledge

    Time frame: baseline; 1-week post-intervention; 3-months post-intervention

    Diabetes knowledge will be assessed using the Diabetes and CVD Knowledge Test, a 15-item assessment of knowledge of self-management strategies based on the ADA Standards of Medical Care in Diabetes. A total score will be computed at each time point by summing all correct responses.

  6. Diabetes self-management behaviors

    Time frame: baseline; 1-week post-intervention; 3-months post-intervention

    Diabetes self-management behaviors will be assessed using the Diabetes Self-Management Questionnaire (DSMQ), which assesses self-management activities in diabetes. A total score will be computed at each timepoint.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth A Vrany

CONTACT

[email protected]

516-600-1483

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Albert Einstein College of Medicine
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Examining the Feasibility of Pairing a Diabetes Self-Management Program With Continuous Glucose Monitoring for Adults With Type 2 Diabetes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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