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Clinical Trial
. 2015 Oct 14;9(6):1192-9.
doi: 10.1177/1932296815608400.

Fluctuations of Hyperglycemia and Insulin Sensitivity Are Linked to Menstrual Cycle Phases in Women With T1D

Sue A Brown  1 , Boyi Jiang  2 , Molly McElwee-Malloy  3 , Christian Wakeman  2 , Marc D Breton  2
Affiliations
Clinical Trial

Fluctuations of Hyperglycemia and Insulin Sensitivity Are Linked to Menstrual Cycle Phases in Women With T1D

Sue A Brown et al. J Diabetes Sci Technol. .

Abstract

Background: Factors influencing glycemic variability in type 1 diabetes (T1D) may play a significant role in the refinement of closed loop insulin administration. Phase of menstrual cycle is one such factor that has been inadequately investigated. We propose that unique individual patterns can be constructed and used as parameters of closed loop systems.

Method: Women with T1D on continuous subcutaneous insulin infusion and continuous glucose monitoring were studied for 3 consecutive menstrual cycles. Ovulation prediction kits and labs were used to confirm phase of menstrual cycle. Glycemic risks were assessed using the low- and high blood glucose indices (LBGI and HBGI). Insulin sensitivity (SI) was estimated using a Kalman filtering method from meal and insulin data. Overall change significance for glycemic risks was assessed by repeated measures ANOVA, with specific phases emphasized using contrasts.

Results: Ovulation was confirmed in 33/36 cycles studied in 12 subjects (age = 33.1 ± 7.0 years, BMI = 25.7 ± 2.9 kg/m(2), A1c = 6.8 ± 0.7%). Risk for hyperglycemia changed significantly during the cycle (P = .023), with HBGI increasing until early luteal phase and returning to initial levels thereafter. LBGI was steady in the follicular phase, decreasing thereafter but not significantly. SI was depressed during the luteal phase when compared to the early follicular phase (P ≤ .05). Total daily insulin, carbohydrates, or calories did not show any significant fluctuations.

Conclusions: Women with T1D have glycemic variability changes that are specific to the individual and are linked to phase of cycle. An increased risk of hyperglycemia was observed during periovulation and early luteal phases compared to the early follicular phase; these changes appear to be associated with decreased insulin sensitivity during the luteal phase.

Keywords: artificial pancreas; closed loop control; continuous glucose monitoring; insulin pump therapy; menstrual cycle; type 1 diabetes.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SAB has received research support from Roche Diagnostics, DexCom, LifeScan, Medtronic, Animas, ConAgra. BJ is an employee of Medtronic. MMM is a consultant/employee for TypeZero Technologies, LLC. MDB has received honoraria/advisory board/consulting from Roche Diagnostics, Bayer, Merck, The Epsilon Group, Becton Dickinson, and Sanofi-Aventis and research support from Animas, DexCom, Insulet, Sanofi-Aventis, Roche Diagnostics, Medtronic, Beckton Dickinson, Bayer, Inspark, Senseonic, and Tandem Diabetes Care. MDB holds patents and patent applications related to the study technology and is a shareholder in TypeZero Technologies, LLC and in Inspark LLC.

Figures

Figure 1.
Figure 1.
Timing of study assessments and interventions across 3 menstrual cycles.
Figure 2.
Figure 2.
Study cycle phases in an idealized 28-day cycle.
Figure 3.
Figure 3.
HBGI, LBGI, and hormone profiles by cycle phase. P values are compared to early follicular phase.
Figure 4.
Figure 4.
Nocturnal SI estimation by KF method (mean ± SD) by menstrual cycle phase. *P = .05 vs early follicular phase. **P = .03 vs early follicular phase.
Figure 5.
Figure 5.
The 3 patterns of SI variations by menstrual cycle phase: (A) 15 out of 36 cycles experienced decreased SI (>5%) in luteal phase; (B) 13 out of 36 cycles experienced unchanged SI (<5%); (C) 8 out of 36 cycles experienced increased SI (>5%). EF, early follicular; MLF, mid-late follicular; O, periovulation; EL, early luteal; ML, mid-luteal; LL, late luteal.
Figure A1.
Figure A1.
Schematic diagram of KF method to track SI.
See this image and copyright information in PMC

References

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