An observational study in Breast Cancer, Pancreatic Cancer and Diabetes, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
The purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 3 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited through the breast and gastrointestinal (GI) medicine oncology clinics at MSKCC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either:
Exclusion Criteria:
A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of breast neoadjuvant chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.
A blinded continuous glucose monitor (specifically a Freestyle Libre Pro) will be worn for a 14 day period by patients during the first and third cycles of pancreatic chemotherapy. At the end of that period (after completion of the one round of chemotherapy) readings will be downloaded from the sensor and the sensor will be removed. Readings will be evaluated by the treating endocrinologist as well as the study team and appropriate clinical interventions.
severe hyperglycemia
glucose \> 400 mg/dL for over 3 contiguous hours
Time frame: 1 year
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Ran from Dec 2019 to primary completion in Oct 2023, 46 months.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's 46 months is below that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center →