Clinical trial · Interventional
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysglycemia | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEXCOM Continuous Glucose Monitor (CGM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm - CGM
- description
- 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.
- interventionNames
- Device: DEXCOM Continuous Glucose Monitor (CGM)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.
Primary outcomes (1)
- measure
- Difference between change in hemoglobin A1C
- timeFrame
- 90 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: For aim 1: * Aged 18-45 * Female sex * Agree to wear a CGM for 10 days * Have access to an apple or android smart phone for CGM monitoring * Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea For aim 2: * All of the inclusion criteria for aim 1 * Meet 2003 Rotterdam criteria for PCOS as above * Evidence of baseline glycemic dysregulation including any of the following: 1) elevated fasting glucose (100-125 mg/dL), 2) elevated 2 hour glucose (140-200 mg/dL), 3) elevated fasting insulin (\>10 mIU/mL), 4) elevated 2 hour insulin (\>40 mIU/mL), 5) elevated Hgba1c (5.7- 6.4) Exclusion Criteria: For both aims 1 and 2: * Use of metformin or other anti-diabetic agents * Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose \>126, 2 hour glucose \>200, Hgba1c \>6.5) * Prior or current use of CGM
References
Publications (3)
- BACKGROUNDTatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443. PMID 35869507
- BACKGROUNDLegro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2. PMID 14752302
- BACKGROUNDDiamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12. PMID 23065822