Glucose Monitoring After Acute Myocardial Infarct in People With Diabetes
GLAM
1 other identifier
interventional
160
1 country
1
Brief Summary
Glucose monitoring after Acute Myocardial infarct in people with diabetes is a Dexcom funded study that is investigating whether the use of continuous glucose monitors (Dexcom ONE model) in people with type 2 diabetes facilitates time in glycaemic range in the 6 months after an acute myocardial infarction. As an exploratory outcome it will investigate whether time in glycaemic range is associated with changes in mortality and major adverse cardiac events in the 6 months after acute myocardial infarct.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 3, 2024
July 1, 2024
1.5 years
June 13, 2022
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome: Percent time spent in glucose target range (3.9-10mmol/L)
Percent time spent in glucose target range (3.9-10mmol/L)
26 weeks
Secondary Outcomes (13)
Number hypoglycaemic excursions.
26 weeks
Time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL; <3.0mmol/L, 54mg/dL),
26 weeks
Time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL).
26 weeks
Time in hyperglycaemia (>10mmol/L, 180mg/dL).
26 weeks
Hypoglycaemia requiring 3rd party assistance.
26 weeks
- +8 more secondary outcomes
Other Outcomes (6)
MACE endpoint defined as death due to cardiac cause or hospitalisation with acute coronary syndrome (including MI and unstable angina); heart failure; unscheduled revascularisation; arrhythmia; cerebrovascular event
26 weeks
All cause mortality
26 weeks
Duration of hospital admission before 'medically fit for discharge'.
26 weeks
- +3 more other outcomes
Study Arms (4)
Real time CGM post acute myocardial infarct
EXPERIMENTALReal time Dexcom ONE CGM system to be applied for 26 weeks post acute myocardial infarct. Option for participants in this group to continue using rCGM in an open label observational extension phase for a total of 3 years.
Blinded CGM post acute myocardial infarct
NO INTERVENTIONBlinded Dexcom ONE CGM system to be applied for 10 days at recruitment, and then at days 17-23, week 10 and week 24. This will be for the purposes of monitoring glucose only and is not an intervention and is blinded to the participants and the study investigators. CGM measurements will be blinded until the end of the study. Management of diabetes in this cohort as per usual standards of care.
Blinded CGM historical acute myocardial infarct (>6 months and <10 years ago)
NO INTERVENTIONBlinded Dexcom ONE CGM system to be applied for 10 days at recruitment. This will be for the purposes of monitoring glucose only and is not an intervention and is blinded to the participants and the study investigators. Management of diabetes in this cohort as per usual standards of care.
Cardiovascular outcomes control group
NO INTERVENTIONAge and sex-matched controls from the NIHR Cardiovascular Health Informatics Collaborative.
Interventions
The Dexcom ONE is comprised of a sensor, transmitter and display device (receiver and/or compatible smart device). The system features a redesigned, one-touch auto-applicator and sleek, discreet transmitter. CGM involves insertion of a small plastic cannula to the subcutaneous tissue of the abdominal skin by members of the study team. The cannula is attached to a small data. The cannula is attached to a small transmitter which is taped to the skin and sends data about interstitial glucose via Bluetooth to a receiver which displays a blood glucose reading. The Dexcom G6 sends glucose readings to a compatible smart device or the Dexcom receiver every 5 minutes.
Eligibility Criteria
You may qualify if:
- From the Hammersmith Hospital In-patient Cardiology Services:
- Adults aged \>18 years
- Known or newly diagnosed type 2 diabetes
- Taking one or more oral hypoglycaemic agent, GLP1 receptor analogue and/or insulin
- Admitted to Hammersmith Hospital cardiology inpatient services with ACS
- Raised blood troponin level on admission
- From Imperial College Healthcare Trust Diabetes and Cardiology Clinics:
- Adults aged \>18 years
- Known type 2 diabetes
- Previous acute coronary syndrome within the last 10 years but \> 6 months ago
- Taking one or more oral hypoglycaemic agent and /or GLP1 receptor analogue, and/or insulin
You may not qualify if:
- From the Hammersmith Hospital In-patient Cardiology Services:
- HbA1c \<48mmol/mol
- People who have previously had bariatric surgery
- People taking hydroxyurea
- People who undergo haemodialysis or peritoneal dialysis
- Unable to participate due to other factors, as assessed by the Chief Investigators
- Pregnancy as determined by clinical team
- Known to have a terminal condition or conditions that suggest a life expectancy less than 1 year
- From Imperial College Healthcare Trust Diabetes and Cardiology Clinics:
- HbA1c \<48mmol/mol
- People who have previously had bariatric surgery
- People taking hydroxyurea
- People who undergo haemodialysis or peritoneal dialysis
- Unable to participate due to other factors, as assessed by the Chief Investigators
- Pregnancy as determined by clinical team
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Hospital inpatient cardiology services
London, United Kingdom
Related Publications (11)
Malmberg K, Ryden L, Hamsten A, Herlitz J, Waldenstrom A, Wedel H. Mortality prediction in diabetic patients with myocardial infarction: experiences from the DIGAMI study. Cardiovasc Res. 1997 Apr;34(1):248-53. doi: 10.1016/s0008-6363(96)00263-5.
PMID: 9217897BACKGROUNDCheung NW, Wong VW, McLean M. The Hyperglycemia: Intensive Insulin Infusion in Infarction (HI-5) study: a randomized controlled trial of insulin infusion therapy for myocardial infarction. Diabetes Care. 2006 Apr;29(4):765-70. doi: 10.2337/diacare.29.04.06.dc05-1894.
PMID: 16567812BACKGROUNDMalmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.
PMID: 7797776BACKGROUNDJackson MA, Ahmann A, Shah VN. Type 2 Diabetes and the Use of Real-Time Continuous Glucose Monitoring. Diabetes Technol Ther. 2021 Mar;23(S1):S27-S34. doi: 10.1089/dia.2021.0007.
PMID: 33534631BACKGROUNDKarter AJ, Parker MM, Moffet HH, Gilliam LK, Dlott R. Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes. JAMA. 2021 Jun 8;325(22):2273-2284. doi: 10.1001/jama.2021.6530.
PMID: 34077502BACKGROUNDYapanis M, James S, Craig ME, O'Neal D, Ekinci EI. Complications of Diabetes and Metrics of Glycemic Management Derived From Continuous Glucose Monitoring. J Clin Endocrinol Metab. 2022 May 17;107(6):e2221-e2236. doi: 10.1210/clinem/dgac034.
PMID: 35094087BACKGROUNDLi M, Chen G, Feng Y, He X. Stress Induced Hyperglycemia in the Context of Acute Coronary Syndrome: Definitions, Interventions, and Underlying Mechanisms. Front Cardiovasc Med. 2021 May 12;8:676892. doi: 10.3389/fcvm.2021.676892. eCollection 2021.
PMID: 34055942BACKGROUNDLee W, Kim SH, Yoon CH, Suh JW, Cho YS, Youn TJ, Chae IH. Impact of Long-term Glycosylated Hemoglobin in Patients with Acute Myocardial Infarction: a retrospective cohort study. Sci Rep. 2020 Apr 21;10(1):6726. doi: 10.1038/s41598-020-63802-1.
PMID: 32317703BACKGROUNDLu J, Wang C, Shen Y, Chen L, Zhang L, Cai J, Lu W, Zhu W, Hu G, Xia T, Zhou J. Time in Range in Relation to All-Cause and Cardiovascular Mortality in Patients With Type 2 Diabetes: A Prospective Cohort Study. Diabetes Care. 2021 Feb;44(2):549-555. doi: 10.2337/dc20-1862. Epub 2020 Oct 23.
PMID: 33097560BACKGROUNDBauters C, Lemesle G, de Groote P, Lamblin N. A systematic review and meta-regression of temporal trends in the excess mortality associated with diabetes mellitus after myocardial infarction. Int J Cardiol. 2016 Aug 15;217:109-21. doi: 10.1016/j.ijcard.2016.04.182. Epub 2016 May 4.
PMID: 27179900BACKGROUNDOser TK, Litchman ML, Allen NA, Kwan BM, Fisher L, Jortberg BT, Polonsky WH, Oser SM. Personal Continuous Glucose Monitoring Use Among Adults with Type 2 Diabetes: Clinical Efficacy and Economic Impacts. Curr Diab Rep. 2021 Dec 9;21(11):49. doi: 10.1007/s11892-021-01408-1.
PMID: 34882273BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Reddy, MBChB, PhD
Imperial College London
- PRINCIPAL INVESTIGATOR
Jamil Mayet, MBChB, MD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
June 24, 2022
Study Start
February 7, 2023
Primary Completion
August 1, 2024
Study Completion
February 1, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share