Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
Conditions: Type 1 Diabetes Mellitus
Sponsor: University of Virginia

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
NCT04665999 
 
 
Version Date 09-28-21 
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PROTOCOL 
Background 
1. Provide the scientific background, rationale and relevance of this project.   
INSTRUCTIONS 
• This should include a referenced systematic evidenced-based review when possible.   
• If this study involves qualitative research explain the major constructs of your study.  
• Do not state in this section what you plan to do in this study.  This information 
should be entered later under “What will be done in this protocol?” 
• Do not include the bibliography in this section. 
• For studies submitted under the Expedited review criteria, this section need not be 
more than a few paragraphs.  
• For those studies where data will be analyzed collaboratively by multiple sites doing 
a similar study for which there is no common protocol (Collaborative Site Analysis 
Study) include a description of the common scientific goals/ procedures/data points. 
• If this is a FIVE YEAR UPDATE make sure the information throughout the protocol 
includes the most current information.  
Type 1 diabetes (T1D) is a chronic metabolic condition characterized by the autoimmune 
destruction of insulin-producing pancreatic beta-cells [1]. As a consequence of this damage, 
individuals with T1D are not capable of endogenous insulin secretion and need to rely on 
exogenous insulin to control their blood glucose levels. Despite the improved accuracy of 
glucose monitoring devices [2],[3] and the growing development of decision support 
systems [4]-[5], achieving good glycemic control in T1D remains a challenge. In fact, insulin 
dosing is oftentimes complicated by a wide variety of factors influencing insulin demand 
(e.g., circadian rhythms [6], psychological stress [7], and physical activity [8]-[9]), which – if 
not properly accounted for – typically lead to increased glucose variability and worsened 
glycemic control. Among these, phases of the menstrual cycle have been shown to 
significantly impact insulin sensitivity (SI) and glycemic variability in females with T1D. 
Specifically, preliminary studies have documented that insulin requirements are significantly 
higher in the luteal phase of the cycle as compared to the early follicular, leading to increased 
exposure to hyperglycemia following ovulation [10]-[13]. With this project, we aim to further 
characterize SI fluctuations across the menstrual cycle in females with T1D and their impact 
on glycemic variability and quality of glycemic control; furthermore, we intend to investigate 
the impact of oral contraceptive therapy on the stabilization of glycemic control. The results 
from this study will be leveraged in future work to build ad hoc decision support systems to 
improve glycemic control across the menstrual cycle and help females with T1D in the 
management of their disease. 

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
NCT04665999 
 
 
Version Date 09-28-21 
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Objectives/Hypothesis  
INSTRUCTIONS:   
If this study involves biomedical research clearly state the objectives and hypotheses and 
clearly define the primary and any secondary outcome measures.  If this study involves 
qualitative research clearly state your research hypothesis or question.  
 
This section should not include information already included in other sections such as 
background information or information from the procedures section.  
The primary aim of the study is to track and characterize fluctuations of insulin sensitivity and 
glycemic variability in females with T1D across the menstrual cycle, contrasting free-cycling 
females and females under oral contraceptive therapy. 
 
Study Design: Biomedical 
 
1.  Will controls be used? 
No 
►IF YES, explain the kind of controls to be used. 
Answer/Response: 
 
2. What is the study design?  
Example:  case series, case control study, cohort study, randomized control study, 
single-blind, double-blind, met-analysis, systematic reviews, other.  You may also view 
the IRB-HSR Learning Shot on this topic to help you answer this question.  
(http://www.virginia.edu/vpr/irb/learningshots/Writing_protocol_June09/player.html 
This is an observational study. Forty females with type 1 diabetes (age ≥18 to ≤40 years) using 
a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data 
collection. Study participants will include free-cycling females and females following oral 
contraceptive therapy. Study CGMs equipment and activity trackers will be provided for the 
entire data collection period. During data collection, participants will be asked to record meals 
consumed. The Clue App will be used to record dates of the participants’ menses. In addition, 
free-cycling females will be asked to confirm ovulation by means of study-provided ovulation 
kits, and record ovulation dates. At the end of data collection, data will be analyzed to track 
insulin sensitivity and glycemic variability changes across the menstrual cycle, contrasting free-
cycling females and females using oral contraceptives. 
 
3. Does the study involve a placebo? 
No 
 
►IF YES, provide a justification for the use of a placebo 

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
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Answer/Response: 
Human Participants 
Ages: _≥18 to ≤40 years _ 
Sex: 
__F__ 
Race: __All__ 
 
Subjects- see below 
INSTRUCTIONS: For question 1-4 below insert an exact #.  Ranges or OPEN is not 
allowed.  This # should be the maximum # you expect to need to enroll (i.e. sign 
consent) If you are only collecting specimens the number of participants should equate 
to the # of specimens you need.  If you are collecting only data from a chart review the 
number should designate the number of subjects whose medical records you plan to 
review.  Age/ Sex/Race criteria should designate the demographics of participants from 
whom you will obtain the specimen/data. 
1.  Provide target # of subjects (at all sites) needed to complete protocol. 
INSTRUCTIONS: If this is NOT a database protocol, this number should be the same as 
the number of subjects needed to obtain statistically significant results.    
Up to forty (40), free-cycling females and females under oral contraceptive therapy, are 
needed to complete the study. Study team will attempt to recruit an even number of females 
into each group.  
 
2.  Describe expected rate of screen failure/ dropouts/withdrawals from all sites.   
The screen failure/dropout rate is anticipated to be 15%.  
 
3.  How many subjects will be enrolled at all sites?    
INSTRUCTIONS: This number must be the same or higher than the # from question # 1 
in order to account for the # of screen failures, dropouts, withdrawals described in 
question # 2.  
Up to 55 females will be enrolled at UVA.  
 
4.  How many subjects will sign a consent form under this UVa protocol?     
INSTRUCTIONS: If the protocol does not have a consent form- the number listed here 
should reflect such things as the number of subjects from whom specimens will be 
obtained, the number of charts to be reviewed etc.  
Up to 55 females will sign consent at UVA.   
Inclusion/Exclusion Criteria 
INSTRUCTIONS: 

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
NCT04665999 
 
 
Version Date 09-28-21 
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• The inclusion and exclusion criteria should be written in bullet format. 
• This item applicable if the study will require consent (verbal or written).        Unless there 
is a scientific reason for not recruiting a certain type of vulnerable population(e.g. not 
enrolling fetuses, neonates or children in a study regarding Alzheimer’s) list the 
following vulnerable populations under either Inclusion or Exclusion criteria below:  
pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, 
educational or economically disadvantage, non- English speaking subjects . 
• If you will not enroll subjects who do not speak English because certain procedures 
cannot be carried out if the subject does not speak English (e.g. a survey is not validated 
in other languages) insert the following as an Inclusion Criteria:  Willingness and ability 
to comply with scheduled visits and study procedures.   
• If this is a collection of only retrospective* specimens or data, the inclusion criteria must 
include a start and stop date for when specimens/data will be collected.   
• The stop date must be prior to the version date of this protocol. 
• *Retrospective:  all specimens are in a lab at the time this protocol is approved by the 
IRB.  All data exists in medical records or records from previous studies at the time this 
protocol is approved by the IRB.   
1.  List the criteria for inclusion  
• Type 1 diabetes for at least 12 months 
• Use of glucose sensor in the last 6 months 
• Use of insulin pump in the last 6 months 
• Age ≥18 to ≤40 years 
• HbA1c ≤8.5% if measured at screening or available from historical medical report 
performed within the last 6 months; in absence of a valid HbA1c measurement, average 
blood glucose estimated from CGM data to be approximately 200 mg/dL or less  
• Absence of perimenopausal/menopausal symptoms 
• Willingness to keep track of beginning of menstrual cycle 
• Willingness to keep track of ingested carbohydrates 
• Willingness to not become pregnant during study participation 
• Regularly menstruating (at least every month with no missed cycles)  
• Only free-cycling participants: willingness to use ovulation kits to confirm ovulation  
• Only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks 
of active pill and 1 week of placebo 
• Willingness to use the study Dexcom G6 during the study 
• Participants must have Internet access and computer system that meets the 
requirements for uploading the study equipment 

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
NCT04665999 
 
 
Version Date 09-28-21 
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2.  List the criteria for exclusion 
• Pregnancy 
• Hormonal birth control therapy except monophasic pill contraceptive  
• Polycystic ovary syndrome (PCOS) diagnosis 
• Current use of steroids 
• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, 
pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin) 
• Uncontrolled thyroid disease 
• Active fertility treatment 
• Concomitant disease or condition that may compromise patient safety or ability to 
follow the protocol including: planned or current dialysis treatment; moderate to 
advanced nephropathy; known or suspected allergy to medical grade adhesives. 
• Severe hypoglycemia or diabetes ketoacidosis (DKA) in the previous 6 months  
3.  List any restrictions on use of other drugs or treatments. 
INSTRUCTIONS: List only those drugs or treatments that are prohibited while on study, not 
those listed as an exclusion criteria.  
None 
Statistical Considerations 
1. 
Is stratification/randomization involved? 
No 
 
►IF YES, describe the stratification/ randomization scheme. 
INSTRUCTIONS: 
The stratification factors and/or the randomization plan should be identified. If there is 
no randomization component or important patient characteristics that will be used in 
treatment allocation or data analysis, a statement to this effect should be included. 
 
Stratification factors: These are pretreatment patient characteristics which could be 
balanced across treatment arms by design or may be used to determine starting dose or 
treatment allocation. 
 
If randomization is going to be used, the details of the randomization plan should be 
described.  
 
The description should include: 
--the method and timing of randomization 
--the type of randomization scheme that will be used in the study 

IRB-HSR# 190046: Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In 
Women With Type 1 Diabetes   
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--whether or not the randomization masked/blinded/if so, then to whom is it 
masked/blinded 
--who has access to the randomization scheme 
Answer/Response: 
 
►IF YES, who will generate the randomization scheme?  
_____ Sponsor 
_____ UVa Statistician.   Insert name Answer/Response: 
_____ UVa Investigational Drug Service (IDS) 
_____ Other:  Specify   Answer/Response: 
2.  What are the statistical considerations for the protocol?  
The objectives section and the statistical section should correspond, and any objective for 
which analysis is unfeasible should be deleted.  Also, the estimates and non-statistical 
assumptions of the statistical section should be supported by discussion in the background 
section. 
 
The answer to this question should include: 
--Study Design/Endpoints 
--Recap of study objectives and endpoint definitions. An assessment of how study objectives 
will be assessed by identifying & defining which endpoints will be used to assess each 
component of the study objectives. 
--The study design should include contingencies for early stopping, interim analyses, 
stratification factors (If applicable), and any characteristics to be incorporated in analyses.  
--The power/precision of the study to address the major study endpoint(s), the assumptions 
involved in the determination of power/precision. 
--If statistical hypothesis testing is included then specify the null and alternative hypotheses, 
the test statistic, and the type I and II error rates 
--If precision of an estimate, then provide a definition for precision 
--If other, then specify  
This observational trial is not powered to a specific outcome. A sample size of 40 females has 
been chosen with the purpose of being able to compute the Cohen’s d metric once the trial is 
completed. Cohen’s d is defined as the difference between two means divided by a standard 
deviation for the data (standardized difference between two means), and will serve as effect size 
to appropriately power the subsequent main trial. 
 
3.  Provide a justification for the sample size used in this protocol.   
Include sample size calculations or statistical power estimation.  If not applicable, please 
provide explanation.   

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Women With Type 1 Diabetes   
NCT04665999 
 
 
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Also include the anticipated accrual rate, the accrual goal for the study, including accrual goals 
by strata if appropriate, adjustments for drop-outs etc. and study duration. 
The sample size is determined based on the fact that this study is a pilot trial including two groups 
(i.e., free-cycling females and females using oral contraceptives). 
 
4.  What is your plan for primary variable analysis? 
Include primary outcome(s)/predictor variable(s), statistical methods/models/tests to be 
employed, or descriptive summaries as appropriate.  If not applicable, please provide 
explanation.   
The primary variable will be insulin sensitivity (SI) computed using a Kalman filter-based 
algorithm embedding a model of glucose-insulin dynamics; SI will be tracked over the duration 
of the menstrual cycle and compared between phases. 
 
5.  What is your plan for secondary variable analysis?  
Include the following:  
--Secondary outcome(s)/predictor variables, statistical methods/models/tests to be employed, 
or descriptive summaries as appropriate.  If not applicable, please provide explanation.  
--For phase III studies, the power/precision of the study to address the secondary objective(s). 
Secondary variables will include metrics to quantify glycemic variability (e.g., percent time spent 
in different glycemic ranges, low/high blood glucose indices, coefficient of variation). 
 
6. Have you been working with a statistician in designing this protocol? 
Consultation with a professional statistician is highly recommended to ensure good science of 
the study and facilitate the review process.  
No 
 
IF YES, what is their name?   
Answer/Response: 
 
7.  Will data from multiple sites be combined during analysis?   
No 
INSTRUCTIONS:  IF YES, answer the following questions 
 
7(a).  Does the study involve randomization?   
Answer/Response: 
IF YES, will randomization be done at each site or among sites?   
Answer/Response: 
7(b).  Has the sample size calculation considered the variation among sites?  
Answer/Response: 

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7(c).  When combining the data from multiple sites to assess the study results, is the 
effect of the treatment to be tested (or the association to be tested) assumed to be the 
same across sites or vary among sites? What is the modelling strategy? 
Answer/Response: 
7(d). Is there a common protocol used in all sites?  
Answer/Response: 
IF NO, how will differences among sites, such as those related to the 
implementation, inclusion criteria, patient characteristics, or other sites 
characteristics, be considered to assess the study results? 
Answer/Response: 
Study Procedures-Biomedical Research 
1.  What will be done in this protocol?    
INSTRUCTIONS:  
This should include everything that will be done as part of this protocol. Do not repeat 
information that is included in other sections such as Background or Hypothesis 
sections.  
This section should include an indication of which research interventions if any offer a 
prospect for direct benefit and which interventions (invasive measurements, collection 
of blood, tissue, data, surveys, etc.) are being done solely to answer a research question 
and generate generalizable knowledge. If the interventions done solely for research 
purposes are associated with greater than minimal risk they need to be justified. 
Describe and justify any control and experimental arm and include method, dose, and 
duration of drug administration. Reference any claim of clinical equipoise if applicable.   
 
If you are obtaining specimens or data, provide information regarding the type of 
specimen/data, amount of specimen needed and how the specimen/data will be 
obtained and what analysis will be done with the specimen/data. 
 
Special note for studies with waiver of consent/waiver of documentation of consent:  
Include a statement regarding how subjects will be recruited. For other studies this 
information is captured in Recruitment does not need to be duplicated in this section. 
 
Study visits may be performed in-person, phone, or via a secure WebEx.  
 
Participants will be screened and inclusion/exclusion will be reviewed. A urine pregnancy will be 
performed. The subject will also be asked for their medical history, preferably with a physical 
exam, will be requested but not required. Height, weight, and vitals may be self-reported. 
Medical history may be obtained from data collected during prior clinical studies conducted from 
the past 24 months at CDT. Subjects will also have an HbA1c test completed upon enrollment. If 
the screening is performed remotely, the pregnancy test will be mailed to the participant. The 

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pregnancy test must be negative to proceed in the trial. While optional, participants will be asked 
to provide 3-months of pre-study personal CGM data.  
 
Eligible participants will start a 3-month home data collection. During data collection, subjects 
will be asked to use a study-provided Dexcom G6 continuous glucose monitor, personal insulin 
pump, and a study-provided activity tracker. Participants who are not on oral contraceptive will 
be asked to use an ovulation kit to confirm ovulation. All participants will be asked to record the 
carbohydrates consumed each day (i.e. meals, snacks, carbohydrate treatments). Unbolused 
carbohydrates will be recorded in the Dexcom app or receiver, not in the participant’s insulin 
pump. Participants will also be instructed to record Day 1 of their menstrual cycle each month 
into the Clue App. Free cycling participants will be asked to enter the monthly ovulation test 
results in the app as well.  
 
Some study participants have prior use of diabetes data aggregators (e.g., Tidepool, Nightscout) 
and do want to switch to another data aggregator. The study team did not request that they use 
Tidepool or Nightscout; however,  so not to interrupt their standard of care, the study may access 
study data stored at Tidepool and Nightscout  in order to save it on a UVA server for analysis. This 
may require participants sharing personal login information to the study team to access data or 
study participants may share this data with the team.   
 
If the subject owns a personal laptop device, the participant will be asked to bring it to the visit 
for the study team to download specific software to be used during data collection if an in person 
screening is performed; otherwise, the study team will instruct the subject how to download the 
software from online website or the study team may provide the subject with a memory drive 
(USB) storing the appropriate resources to be used at home will be provided. Participants will be 
instructed on how to upload the equipment (i.e. insulin pump, CGM, Activity Tracker, Clue App, 
etc.). Participants will be asked to provide uploaded data periodically during the data collection 
period (approximately 1-2 times per month) using a local diabetes device management software 
(e.g., Dexcom Studio). Subjects will have the option of using their personal smartphone or receive 
a study smartphone to use in order to collect the data from the devices. 
 
Participants will be asked to wear the study activity monitor during the data collection phase. 
Participants will also wear the activity monitor to collect information on activity, exercise, heart 
rate, and sleep. The commercially available app associated with the activity monitor will be 
placed on the smartphone to facilitate weekly downloading of data. 
 

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Women With Type 1 Diabetes   
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The study team will contact the participant via phone/email/text at least one time month to 
assess: 
• Adverse events and device issues 
• Review download of CGM and activity monitor to assess occurrence of glucose values 
<60 mg/dL and >300 mg/dL  
• Verify Clue App monthly download – the study team logging into the subject’s  study 
account to verify its use and download data  
Study Schedule 
 
Screening 
Monthly  
Monitoring 
Final 
Study Days 
1* 
2-90 
 ~90 
Visit 
1 
2,3,4 
5 
Informed consent 
x 
 
 
Review study eligibility 
x 
 
 
Medical history (optional) 
x 
 
 
Pregnancy test 
x 
 
x 
Physical exam (optional), height, 
weight, and vital signs (self-reported) 
x 
 
 
HbA1c 
x 
 
x 
CGM use 
x 
 
 
Activity tracker use 
 
x 
 
Ovulation test (if applicable) 
 
x 
 
Record menses in app 
 
x 
 
Data uploads provided to study team 
 
x 
x 
Monthly check-ins with staff 
 
x  
 
Return study equipment 
 
 
x 
* Visit 1 may be split over 2 days  
 
Participants will return all study equipment and remaining supplies at the end of the study. A 
hemoglobin A1c value will be collected and assessed on a point of care machine, a local 
laboratory, or derived from blood glucose data. 
 
Upon completion of data collection, data will be analyzed to identify patterns in glucose 
metabolism across the menstrual cycle, and contrast free-cycling females to females using oral 
contraceptives. 
 
If a subject is considered a screen failure, they will be replaced. Subjects who withdraws from the 
study will be replaced per the Principal Investigator’s discretion. Should any study subject receive 

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Women With Type 1 Diabetes   
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a positive test result for COVID-19, they should tell the study team but will continue to use the 
study equipment as it is commercially available equipment. 
 
2. If this protocol involves study treatment, explain how a subject will be transitioned from 
study treatment when they have completed their participation in the study.   
Example:  If the subject will be taking an investigational drug, will they need to be put 
back on an approved drug when they have completed the study?  If yes, explain how 
this will be accomplished and who will cover the cost.  If the subject has a device 
implanted will it be removed?  Again- who will cover the cost of the removal?   
Instructions: Answer NA if this study does not involve a study treatment.   
The study equipment provided to participants during the trial are commercially available items 
and will be used per labeling instructions. Participants will return to their usual care at study end.  
 
Subject Compliance with Study Procedures 
1.  Explain how the study team will monitor the subject for compliance with the study 
procedures. 
 (e.g. study team will administer study drug/ study interventions, study drug inventory 
of dispensed and returned drug, diary etc.) 
Answer/Response: Study team will regularly check the Dexcom Clarity account to verify 
usage of the study CGM. Participants will be asked to call the study team as needed 
during the trial, specifically to report medical issues, medical visits, etc. The study team 
will also have monthly check-in with the participant. 
 
2.  Describe criteria for when a subject is considered to be non-compliant with study 
procedures.   
(e.g. subject returns more than 20% of the study drug, subject misses 20% of study 
visits) 
Answer/Response: 
• subject does not use the glucose sensor for more than 25% of the study  
• subject does not download devices per study schedule 
 
Bibliography 
INSTRUCTIONS:  Provide a current bibliography supporting the hypothesis, background and 
methodology including references to papers and abstracts that have resulted from previous 
work by the investigator and references to the work of others. 
[1] American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 
2014;37(S1):S81-90. 
[2] Klonoff DC, Prahalad P. Performance of Cleared Blood Glucose Meters. J Diabetes Sci Technol. 
2015;9(4):895-910. 

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[3] Klonoff DC, Ahn D, Drincic A. Continuous Glucose Monitoring: A Review of the Technology and Clinical 
Use. Diabetes Res Clin Pract. 2017;133:178-192. 
[4] Breton MD, Patek SD, Lv D, Schertz E, Robic J, Pinnata J, Kollar L, Barnett C, Wakeman C, Oliveri M, 
Fabris C, Chernavvsky D, Kovatchev BP, Anderson SM. Continuous Glucose Monitoring and Insulin 
Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability 
in Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2018;20(8):531-40. 
[5] Nimri R, Ochs AR, Pinsker JE, Phillip M, Dassau E. Decision Support Systems and Closed Loop. Diabetes 
Technol Ther. 2019;21(S1):S42-56. 
[6] Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. Quantitative Estimation of Insulin Sensitivity in 
Type 1 Diabetic Subjects Wearing a Sensor-Augmented Insulin Pump. Diabetes Care. 2014;37(5):1216-
23. 
[7] screeLi L, Li X, Zhou W, Messina JL. Acute Psychological Stress Results in the Rapid Development of 
Insulin Resistance. J Endocrinol. 2013;217(2):175-84. 
[8] Dalla Man C, Breton MD, Cobelli C. Physical Activity into the Meal Glucose-Insulin Model of Type 1 
Diabetes: In Silico Studies. J Diabetes Sci Technol. 2009;3(1):56-67. 
[9] McMahon SK, Ferreira LD, Ratnam N, Davey RJ, Youngs LM, Davis EA, Fournier PA, Jones TW. Glucose 
Requirements to Maintain Euglycemia after Moderate-Intensity Afternoon Exercise in Adolescents 
with Type 1 Diabetes Are Increased in a Biphasic Manner. J Clin Endocrinol Metab. 2007;92(3):963-8. 
[10] Scott AR, Macdonald IA, Bowman CA, Jeffcoate WJ. Effect of Phase of Menstrual Cycle on Insulin 
Sensitivity, Peripheral Blood Flow and Cardiovascular Responses to Hyperinsulinaemia in Young 
Women with Type 1 Diabetes. Diabet Med. 1990;7(1):57-62. 
[11] Moberg E, Kollind M, Lins PE, Adamson U. Day-To-Day Variation of Insulin Sensitivity in Patients with 
Type 1 Diabetes: Role of Gender and Menstrual Cycle. Diabet Med. 1995;12(3):224-8. 
[12] Trout KK, Rickels MR, Schutta MH, Petrova M, Freeman EW, Tkacs NC, Teff KL. Menstrual Cycle Effects 
on Insulin Sensitivity in Women with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 
2007;9(2):176-82. 
[13] Brown SA, Jiang B, McElwee-Malloy M, Wakeman C, Breton MD. Fluctuations of Hyperglycemia and 
Insulin Sensitivity Are Linked to Menstrual Cycle Phases in Women With T1D. J Diabetes Sci Technol. 
2015;9(6):1192-9.