Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diabetes Mellitus

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

monitoring daily exercise-related activities

Fitbit

Continuous Glucose Monitor

Karen Basen-Engquist, MD

To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Primary objective:

To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®.

Secondary objectives:

To examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention.

Exploratory objective:

Examine cancer-related biomarkers and their associations with daily glucose pattern.

Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices

The use of CGM through the following criteria: CGM-specific refusal rate \<20% at the participant recruitment phase and protocol adherence rates \>80% at the end of the monitoring period.

M.D. Anderson Cancer Center

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Ischemia

Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring

Edward Liu, MD

Ronen Avram, MD

Jiayi Hu, MD

Achilleas Thoma, MD

Matthew McRae, MD

A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this study, the investigators aim to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.

Background:

Breast reconstruction involving microvascular free tissue transfer is a major, labour-intensive operation that provides numerous benefits for patients' psychosocial function and well-being.

Flap failure, though rare, is a devastating complication and leads to serious morbidities. It can occur in the first 24-72 hours after the operation. However, if ischemia is detected earlier, the chances for operative salvage are better. Unfortunately, the current monitoring process remains mostly subjective.

A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival.

Purpose:

The overall objective of this clinical pilot study is to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.

Methods:

In this pilot cohort study, the investigators aim to prospectively include 30 free flaps in total from 10-20 patients undergoing DIEP-based breast reconstruction by one surgeon at Juravinski Hospital. Patients will be recruited at the pre-operative consultation. The transcutaneous sensor of the CGM device will be inserted into the subcutaneous layer of the flap upon completion of surgery, while an additional sensor will be placed on the patient's thigh as control. These devices are blinded and will start recording the flap's interstitial glucose levels. The patient will be admitted and the flap will be assessed clinically as per protocol. On-call residents will be given a data collection sheet to document the exact time they were alerted about a flap, the clinical finding, and the subsequent decision made. Once an endpoint has been reached for a flap, the CGM sensor will be removed and its data extracted.

Data Analysis:

The timing of occurrence of low interstitial glucose levels and rapid glucose level decline will be analyzed with the timing of clinical concerns raised about the flap. The systemic glucose level will be used as a control for the flap glucose level. The investigators aim to analyze the temporal correlation between interstitial glucose measurements and clinical findings of the flap's vascular status (eg. vessel occlusion, ischemia). Statistical analysis will be done with assistance by a biostatistician.

Detection of Flap Ischemia Using Interstitial Glucose Monitor

Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study

Thoma, Achilleas

Jiayi Hu

Matthew McRae

Hamilton Health Sciences Corporation

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days.

Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.

Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose.

DEXCOM Continuous Glucose Monitor (CGM)

Heather Huddleston, MD

Nik Lenhart

Heather G Huddleston, MD

PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.

Study synopsis:

Recruitment:

* PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic.
* Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects.

Study protocol:

Aim 1:

Pre-DEXCOM evaluation:

PCOS participants:

* As part of routine clinical care all PCOS participants will have had the following procedures completed:
* Blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D.
* Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
* In person clinical evaluation including physical exam and history.
* In person transvaginal ultrasound assessment.
* The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting.
* Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)

Non-PCOS participants:

* Participants will have blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH- Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D obtained.
* Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained.
* Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic, which include questions on ethnicity, family, medical, and social history.
* If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials, the above labs will be collected and paid for by the research protocol.
* Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)

Procedures:

DEXCOM evaluation:

* PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM.
* Participants will be asked to complete the automated self-administered 24-hour dietary assessment (ASA24) tool, which is a web based, validated 24 hour dietary record program, produced by the National Cancer Institute (NCI)/Nation Institute of Health and made available free of charge to researchers.
* As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record. See attached module.
* All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM.

Aim 2:

Recruitment:

* From those participants with PCOS recruited for Aim 1, a subgroup with evidence of dysglycemia (as outlined in the inclusion criteria) will be recruited for aim 2.
* Participants will be randomized in a 3:1 fashion to intervention with CGM vs control.

Procedures:

Intervention group:

* All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
* Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application.
* Participants will be asked to use a CGM continuously for 90 days.
* After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
* After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
* After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period

Control group:

* All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
* After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
* After 90 days, participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose.
* After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
* After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period

Data Management:

Clinical and laboratory data will be stored in a Research Electronic Data Capture (REDCap) system designed by Dr. Huddleston and research staff. Fields will be designed by study coordinators with input from key investigators. Our team has extensive experience with REDCap architecture and utilization.

Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days

Difference between change in fasting insulin for 2 treatment arms from baseline to after 90 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices	NCT05124405	Cancer Diabetes	Fitbit Continuous Gluc...	18 Years -	M.D. Anderson Cancer Center
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation
Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices	NCT05124405	Cancer Diabetes	Fitbit Continuous Gluc...	18 Years -	M.D. Anderson Cancer Center
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation
Detection of Flap Ischemia Using Interstitial Glucose Monitor	NCT02604069	Free Tissue Fla...	Continuous Gluc...	-	Hamilton Health Sciences Corporation
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome	NCT06050265	PCOS (Polycysti... Dysglycemia Insulin Resista...	DEXCOM Continuo...	18 Years - 45 Years	University of California, San Francisco

Spots Global Cancer Trial Database for continuous glucose monitor