Diabetes MellitusNCT07548372

SPARK-CGM Implementation

A study testing Enhanced CGM Interventions in people with Diabetes Mellitus, run by Montefiore Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Enhanced CGM Interventions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20,000 participants
Where: 1 siteUnited States
Study dates: 1 May 2026to May 2028
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

Clinic level:
All adult Montefiore primary care sites
Clinician and clinic staff will be eligible if they provide direct patient care or are involved in CGM prescribing, authorization, onboarding, or education at participating primary care clinics. Eligible clinicians include physicians, nurse practitioners, physician assistants, and clinicians in training. Eligible clinic staff may include nurses, medical assistants, and other relevant administrative staff
Patient level:
Age 18 years or older
Receive primary care at participating sites
Diagnosis of any diabetes mellitus
Treated with insulin therapy

Who cannot join

Clinic level:
Sites participating in pilot phase of CGM initiative
Patient level:
Existing CGM prescription within 24 months before the study start

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rosina Antwi contact

646-515-8399

rosina.antwi@einsteinmed.edu

United States1 site, 1 recruiting

Montefiore Medical Group (MMG)
The Bronx, New York, 10467
Recruiting

Other trials in United States

About this study

Official title: Supporting Primary Care Adoption, Resources, and Knowledge for Continuous Glucose Monitoring

Continuous glucose monitoring (CGM) is a technology that helps individuals with diabetes track their sugar levels in real-time, leading to more in-range blood sugars, fewer episodes of dangerously low blood sugar, and improved quality of life. Despite these benefits, CGM is not widely used in primary care settings, where most people receive their diabetes care. The investigators aim to make CGM more accessible and equitably prescribed in primary care practices. The study team will support primary care to increase CGM use with a program called SPARK-CGM (Supporting Primary Care Adoption, Resources, and Knowledge for CGM) across a large network of primary care clinics at Montefiore Medical Center. This program will provide primary care providers (PCPs) with education, tools, and support to incorporate CGM into their routine care for people with diabetes. Investigators plan to test SPARK-CGM to evaluate whether it increases CGM prescriptions who are eligible to receive this technology.

Read the detailed description

Continuous glucose monitoring (CGM) has been shown to reduce HbA1c levels, hypoglycemia, and improve quality of life, representing a powerful tool to improve population-level outcomes in diabetes. The American Diabetes Association (ADA) recommends CGM for all individuals with any type of diabetes on insulin, but its widespread adoption into primary care remains low.

SPARK-CGM (Supporting Primary care Adoption, Resources, and Knowledge for CGM) is a hybrid effectiveness-implementation trial evaluating a multifaceted practice transformation package designed to increase new continuous glucose monitoring (CGM) prescriptions among adult patients with diabetes treated wtih insulin. This includes: (1) strengthening clinic capacity by streamlining CGM prescribing pathways; (2) optimizing pharmacy and insurance authorization workflows to reduce administrative burden; (3) providing prescriber-focused training on CGM workflows, data access, and interpretation to support effective clinical use; (4) training nursing and support staff to facilitate device initiation, patient education, and data management; and (5) delivering regular performance feedback on prescribing rates across clinics and providers.

The effectiveness component will be evaluated using a stepped-wedge cluster randomized trial in which primary care clinic clusters sequentially transition from usual care to the SPARK-CGM implementation intervention over the study period until all clinics receive the intervention. The implementation component will include mixed-methods evaluation using surveys and semi-structured interviews with patients, providers and clinic staff to assess implementation outcomes.

Based on pre-implementation clinic counts, the stepped-wedge trial will include 14 non-pilot primary care clinics. The investigators expect to include up to approximately 20,000 adult patients with insulin-treated diabetes who may contribute data to the effectiveness analysis (Aim 1) during the study period . For implementation evaluation and semi-structured interviews (Aim 2), investigators plan to recruit up to 40 adults with insulin-treated diabetes (10 per cluster) and 15-20 clinicians or clinic staff participants (4-5 per cluster) in order to reach thematic saturation.

Conditions: Diabetes Mellitus
Being tested: Enhanced CGM Interventions, Standard of Care
Keywords: Implementation, HbA1c, Multi-component Implementation, Continuous glucose monitoring
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced CGM InterventionsOther
The study intervention involves creating a streamlined workflow for CGM prescribing that does not restrict the treatment options available to patients or clinicians. SPARK-CGM implementation strategy includes three core practice transformations: (1) building clinic infrastructure by establishing CGM prescription workflows, and by training clinic staff to place CGM devices at the point of care, (2) provider training on accessing and using CGM data effectively in practice, and (3) regular feedback on prescription rates across the network.
Standard of CareOther
Usual care

Study groups in NCT07548372
Study group	Role	What they receive
Implementation Phase	Experimental	Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention. The active implementation phase at each cluster will span six months, providing sufficient time to equip clinics to use CGM. The intervention includes development of clinic workflows for CGM prescribing and onboarding, provider education on CGM use and interpretation, training of clinic staff to support CGM initiation, and regular performance feedback on CGM prescribing rates. Receives: Other: Enhanced CGM Interventions
Pre-implementation phase	Active comparator	Patients in pre-implementation practices will receive the usual care under the direction of their primary care provider and practice. Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to first CGM prescription by primary care provider
Time to first CGM prescription initiated by a primary care provider (PCP) will be defined as the date from a patient's first eligible primary care encounter during the study period to the date of the first CGM prescription, up to 18 months following intervention initiation, as recorded in the electronic health record. All CGM orders are captured in the EHR. Results will be summarized by study arm using descriptive statistics and analyzed using Cox proportional hazards models.
Measured: Up to 18 months following initiation of intervention

Secondary outcomes (9)

CGM Utilization
A dichotomous (binary) measure of CGM usage obtained from device platforms and/or EHR. CGM utilization will be summarized by study arm using descriptive statistics.
Measured: Up to 18 months following initiation of intervention
HbA1c
Longitudinal repeated HbA1c measures over time will be obtained from EHR. HbA1c results will be summarized by study arm using descriptive statistics.
Measured: Up to 18 months following initiation of intervention
Hospitalizations
The number/percentage of patients who were admitted for inpatient hospitalization will be assessed based on data available from EHR from the initiation of the intervention to the end of the study, up to 18 months.
Measured: Up to 18 months following initiation of intervention
Emergency Department (ED) visits
The number/percentage of patients who visited an ED will be assessed based on data available from EHR from the initiation of the intervention to the end of the study, up to 18 months.
Measured: Up to 18 months following initiation of intervention
CGM prescription rate by race/ethnicity and payor
The number/percentage of participants with CGM will be evaluated by race/ethnicity and payor based on data available from EHR from the initiation of the intervention to the end of the study, up to 18 months.
Measured: Up to 18 months following initiation of intervention
Longitudinal glucose time in range (TIR)
TIR (i.e., percent time spent in glucose range 70-180 mg/dL) will be collected longitudinally among patients using CGM in the post-implementation trial phase. Repeated TIR measures will be obtained from device platforms and/or the EHR at baseline and throughout follow-up. Average TIR levels over time will be analyzed to assess within-participant change over time.
Measured: Up to 18 months following initiation of intervention
Longitudinal glucose time below range (TBR)
TBR (i.e., percent time spent in glucose range <70 mg/dL) will be collected longitudinally among patients using CGM in the post-implementation trial phase. Repeated TBR measures will be obtained from device platforms and/or the EHR at baseline and throughout the follow-up. Average TBR levels over time will be analyzed to assess within-participant change over time.
Measured: Up to 18 months following initiation of intervention
Longitudinal glucose time above range (TAR)
TAR (i.e., percent time spent in glucose range >180 mg/dL) will be collected longitudinally among patients using CGM in the post-implementation trial phase. Repeated TAR measures will be obtained from device platforms and/or the EHR at baseline and throughout the follow-up. Average TAR levels over time will be analyzed to assess within-participant change over time.
Measured: Up to 18 months following initiation of intervention
Longitudinal glucose management indicator (GMI)
GMI measures will be collected longitudinally among patients using CGM in the post-implementation trial phase. Repeated GMI measures will be obtained from device platforms and/or the electronic health record at baseline and throughout the follow-up. Average GMI levels over time will be analyzed to assess within-participant change over time.
Measured: Up to 18 months following initiation of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 2026May 2028

First posted23 Apr 2026
Study start1 May 2026
Primary completionMay 2028 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
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
Model description: This study uses type II hybrid effectiveness-implementation design combining (1) stepped-wedge cluster randomized trial (SW-CRT) evaluating effectiveness of SPARK-CGM and (2) post-intervention mixed methods implementation evaluation including interviews and surveys with patients, providers and clinic staff. Participating clinics will be randomized into four mutually exclusive cluster waves, stratified by clinic size, defined by the number of patients with insulin-treated diabetes, and by federally qualified health center status to ensure balance across waves. Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention.
Masking: None (open label)
Enrolment: 20,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07548372
Sponsor's protocol ID: 2025-16972
Other IDs: 7-25-JDFPC-403, 2025
Status last verified: Jun 2026
First submitted: 16 Apr 2026
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data sharing plan includes the following: In Specific Aim 1, valuable SPARK-CGM efficacy data may be of interest to other diabetes, health equity and primary care researchers. In Specific Aim 2, in-depth qualitative data of PCP and patients with diabetes may be of interest to investigators who want to apply similar interventions to new populations. Information on analytic methods will be shared with other collaborators, including providing statistical code and process logs that could be used to either confirm our results or apply similar statistical methods to related projects. Additional resources developed during this project, such as study protocols, educational materials for primary care providers, will be shared upon request or made available through appropriate channels

Publications

Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.
PubMed 34077499
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
PubMed 18779236
Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
PubMed 28118453
Wada E, Onoue T, Kobayashi T, Handa T, Hayase A, Ito M, Furukawa M, Okuji T, Okada N, Iwama S, Sugiyama M, Tsunekawa T, Takagi H, Hagiwara D, Ito Y, Suga H, Banno R, Kuwatsuka Y, Ando M, Goto M, Arima H. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001115. doi: 10.1136/bmjdrc-2019-001115.
PubMed 32518063
Heinemann L, Deiss D, Hermanns N, Graham C, Kaltheuner M, Liebl A, Price D. HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2015 May;9(3):651-62. doi: 10.1177/1932296815575999. Epub 2015 Mar 9.
PubMed 25759183
Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
PubMed 28000140
Johnston AR, Poll JB, Hays EM, Jones CW. Perceived impact of continuous glucose monitor use on quality of life and self-care for patients with type 2 diabetes. Diabetes Epidemiology and Management. 2022;6:100068. doi:10.1016/j.deman.2022.100068
Polonsky WH, Hessler D. What are the quality of life-related benefits and losses associated with real-time continuous glucose monitoring? A survey of current users. Diabetes Technol Ther. 2013 Apr;15(4):295-301. doi: 10.1089/dia.2012.0298. Epub 2013 Feb 21.
PubMed 23427866
Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
PubMed 28389582
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S111-S127. doi: 10.2337/dc23-S007.
PubMed 36507635
Grunberger G, Sze D, Ermakova A, Sieradzan R, Oliveria T, Miller EM. Treatment Intensification With Insulin Pumps and Other Technologies in Patients With Type 2 Diabetes: Results of a Physician Survey in the United States. Clin Diabetes. 2020 Jan;38(1):47-55. doi: 10.2337/cd19-0008.
PubMed 31975751
Mayberry LS, Guy C, Hendrickson CD, McCoy AB, Elasy T. Rates and Correlates of Uptake of Continuous Glucose Monitors Among Adults with Type 2 Diabetes in Primary Care and Endocrinology Settings. J Gen Intern Med. 2023 Aug;38(11):2546-2552. doi: 10.1007/s11606-023-08222-3. Epub 2023 May 30.
PubMed 37254011
Oser TK, Hall TL, Dickinson LM, Callen E, Carroll JK, Nease DE Jr, Michaels L, Oser SM. Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care. Ann Fam Med. 2022 Nov-Dec;20(6):541-547. doi: 10.1370/afm.2876.
PubMed 36443083
Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010 Dec;85(12 Suppl):S3-4. doi: 10.4065/mcp.2010.0466. Epub 2010 Nov 24. No abstract available.
PubMed 21106869
Pilla SJ, Segal JB, Maruthur NM. Primary Care Provides the Majority of Outpatient Care for Patients with Diabetes in the US: NAMCS 2009-2015. J Gen Intern Med. 2019 Jul;34(7):1089-1091. doi: 10.1007/s11606-019-04843-9. No abstract available.
PubMed 30719646

Interested in taking part?

Rosina Antwi

646-515-8399

rosina.antwi@einsteinmed.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supporting Primary Care Adoption, Resources, and Knowledge for Continuous Glucose Monitoring
ClinicalTrials.gov ID: NCT07548372
Acronym / sponsor ID: 2025-16972
Conditions: Diabetes Mellitus
Keywords: Implementation, HbA1c, Multi-component Implementation, Continuous glucose monitoring
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 20,000 participants (estimated)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: American Diabetes Association
Study start: 1 May 2026 (actual)
Primary completion: May 2028 (estimated)
Study completion: May 2028 (estimated)
First posted: 23 Apr 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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study uses type II hybrid effectiveness-implementation design combining (1) stepped-wedge cluster randomized trial (SW-CRT) evaluating effectiveness of SPARK-CGM and (2) post-intervention mixed methods implementation evaluation including interviews and surveys with patients, providers and clinic staff. Participating clinics will be randomized into four mutually exclusive cluster waves, stratified by clinic size, defined by the number of patients with insulin-treated diabetes, and by federally qualified health center status to ensure balance across waves. Clinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention.

Arm	Type	Receives
Implementation Phase	Experimental	Other: Enhanced CGM InterventionsClinics will sequentially transition from the usual care (control) condition to the intervention phase at three-month intervals until all clusters receive the intervention. The active implementation phase at each cluster will span six months, providing sufficient time to equip clinics to use CGM. The intervention includes development of clinic workflows for CGM prescribing and onboarding, provider education on CGM use and interpretation, training of clinic staff to support CGM initiation, and regular performance feedback on CGM prescribing rates.
Pre-implementation phase	Active comparator	Other: Standard of CarePatients in pre-implementation practices will receive the usual care under the direction of their primary care provider and practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

All adult Montefiore primary care sites
Clinician and clinic staff will be eligible if they provide direct patient care or are involved in CGM prescribing, authorization, onboarding, or education at participating primary care clinics. Eligible clinicians include physicians, nurse practitioners, physician assistants, and clinicians in training. Eligible clinic staff may include nurses, medical assistants, and other relevant administrative staff
Age 18 years or older
Receive primary care at participating sites
Diagnosis of any diabetes mellitus

Key exclusion criteria (4 listed)

Sites participating in pilot phase of CGM initiative
Existing CGM prescription within 24 months before the study start

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
Enhanced CGM InterventionsThe study intervention involves creating a streamlined workflow for CGM prescribing that does not restrict the treatment options available to patients or clinicians. SPARK-CGM implementation strategy includes three core practice transformations: (1) building clinic infrastructure by establishing CGM prescription workflows, and by training clinic staff to place CGM devices at the point of care, (2) provider training on accessing and using CGM data effectively in practice, and (3) regular feedback on prescription rates across the network.	Other	Implementation Phase
Standard of CareUsual care	Other	Pre-implementation phase

Primary outcome

Time to first CGM prescription by primary care provider
Time frame: Up to 18 months following initiation of intervention
Time to first CGM prescription initiated by a primary care provider (PCP) will be defined as the date from a patient's first eligible primary care encounter during the study period to the date of the first CGM prescription, up to 18 months following intervention initiation, as recorded in the electronic health record. All CGM orders are captured in the EHR. Results will be summarized by study arm using descriptive statistics and analyzed using Cox proportional hazards models.

9 secondary outcomes

CGM Utilization
Time frame: Up to 18 months following initiation of intervention
HbA1c
Time frame: Up to 18 months following initiation of intervention
Hospitalizations
Time frame: Up to 18 months following initiation of intervention
Emergency Department (ED) visits
Time frame: Up to 18 months following initiation of intervention
CGM prescription rate by race/ethnicity and payor
Time frame: Up to 18 months following initiation of intervention
Longitudinal glucose time in range (TIR)
Time frame: Up to 18 months following initiation of intervention
Longitudinal glucose time below range (TBR)
Time frame: Up to 18 months following initiation of intervention
Longitudinal glucose time above range (TAR)
Time frame: Up to 18 months following initiation of intervention
Longitudinal glucose management indicator (GMI)
Time frame: Up to 18 months following initiation of intervention

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 23 Jun 2026.
Background: PubMed 34077499Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.
Background: PubMed 18779236Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
Background: PubMed 28118453Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
Background: PubMed 32518063Wada E, Onoue T, Kobayashi T, Handa T, Hayase A, Ito M, Furukawa M, Okuji T, Okada N, Iwama S, Sugiyama M, Tsunekawa T, Takagi H, Hagiwara D, Ito Y, Suga H, Banno R, Kuwatsuka Y, Ando M, Goto M, Arima H. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001115. doi: 10.1136/bmjdrc-2019-001115.
Background: PubMed 25759183Heinemann L, Deiss D, Hermanns N, Graham C, Kaltheuner M, Liebl A, Price D. HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2015 May;9(3):651-62. doi: 10.1177/1932296815575999. Epub 2015 Mar 9.
Background: PubMed 28000140Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
BackgroundJohnston AR, Poll JB, Hays EM, Jones CW. Perceived impact of continuous glucose monitor use on quality of life and self-care for patients with type 2 diabetes. Diabetes Epidemiology and Management. 2022;6:100068. doi:10.1016/j.deman.2022.100068
Background: PubMed 23427866Polonsky WH, Hessler D. What are the quality of life-related benefits and losses associated with real-time continuous glucose monitoring? A survey of current users. Diabetes Technol Ther. 2013 Apr;15(4):295-301. doi: 10.1089/dia.2012.0298. Epub 2013 Feb 21.
Background: PubMed 28389582Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
Background: PubMed 36507635ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S111-S127. doi: 10.2337/dc23-S007.
Background: PubMed 31975751Grunberger G, Sze D, Ermakova A, Sieradzan R, Oliveria T, Miller EM. Treatment Intensification With Insulin Pumps and Other Technologies in Patients With Type 2 Diabetes: Results of a Physician Survey in the United States. Clin Diabetes. 2020 Jan;38(1):47-55. doi: 10.2337/cd19-0008.
Background: PubMed 37254011Mayberry LS, Guy C, Hendrickson CD, McCoy AB, Elasy T. Rates and Correlates of Uptake of Continuous Glucose Monitors Among Adults with Type 2 Diabetes in Primary Care and Endocrinology Settings. J Gen Intern Med. 2023 Aug;38(11):2546-2552. doi: 10.1007/s11606-023-08222-3. Epub 2023 May 30.
Behavioral Risk Factor Surveillance System (BRFSS) Health Indicators by County and Region \| State of New York.Link provided by the sponsor.
Glucose\_Monitoring\_Criteria\_-\_10-2-23.pdf.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. The data sharing plan includes the following: In Specific Aim 1, valuable SPARK-CGM efficacy data may be of interest to other diabetes, health equity and primary care researchers. In Specific Aim 2, in-depth qualitative data of PCP and patients with diabetes may be of interest to investigators who want to apply similar interventions to new populations. Information on analytic methods will be shared with other collaborators, including providing statistical code and process logs that could be used to either confirm our results or apply similar statistical methods to related projects. Additional resources developed during this project, such as study protocols, educational materials for primary care providers, will be shared upon request or made available through appropriate channels

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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.

Rosina Antwi contact

646-515-8399

rosina.antwi@einsteinmed.edu

Jovan Milosavljevic, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced CGM Interventions in people with Diabetes Mellitus, run by Montefiore Medical Center 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jun 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?

Contact Rosina Antwi (646-515-8399, rosina.antwi@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first CGM prescription by primary care provider (time frame: Up to 18 months following initiation of intervention). 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 NCT07548372, which also lists 19 linked publications.

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 23 Jun 2026.