Hyperglycaemia Due to Type 1 Diabetes Mellitus, Hypoglycemia, Menstruation Disturbances, Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, menstrual cycle, exercise, hypoglycemia, hyperglycemia, glucose control
Brief summary
The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.
Detailed description
The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims: Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training. Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.
Interventions
OTHERPersonalized modifications to treatment to address menstrual cycle effects on glycemia
The study physician will examine glucose patterns measured using continuous glucose monitoring over a 3 month observational period to identify hypo- or hyperglycemia related to menstrual cycle phase or exercise, and will provide changes to insulin basal or bolus rates, carbohydrate ratios, post-exercise food intake or use of sleep mode on automated insulin delivery systems.
Sponsors
University of Colorado, Denver
The Leona M. and Harry B. Helmsley Charitable Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-45 who have had type 1 diabetes for at least 12 months * Premenopausal with either menstrual cycles or currently using oral contraceptives
Exclusion criteria
* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose time in range | 3 months during randomization to intervention or standard care | time spent with glucose 70-180mg/dL on continuous glucose monitor |
| Glucose standard deviation | 3 months during randomization to intervention or standard care | standard deviation (mg/dL) of glucose on continuous glucose monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose (mg/dL) pre-exercise | mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data | Mean glucose from continuous glucose monitor in response to exercise |
| Mean glucose (mg/dL) while exercising | mean glucose measured every 5 minutes while actively exercising (between exercise start and end times as reported by study participant or based on accelerometer data, from a minimum of 5 minutes to up to 480 minutes) | Mean glucose from continuous glucose monitor in response to exercise |
| Mean glucose (mg/dL) over 24 hours after exercise | mean glucose during the 24 hours after beginning planned exercise bouts (from participant reported or acceleromater data based start of exercise to 24 hours later) | Mean glucose from continuous glucose monitor in response to exercise |
| Glucose standard deviation | glucose standard deviation during the follicular (starting day one of the menstrual period as self-reported by study participant through a positive home test for ovulation by participant, or for a maximum of 30 days if no positive ovulation test) | standard deviation (mg/dL) of glucose on continuous glucose monitor |
Countries
United States
Contacts
CONTACTJANET K SNELL-BERGEON, PhD, MPH
CONTACTCatherine Chartier-Logan, MPH
PRINCIPAL_INVESTIGATORJANET K SNELL-BERGEON, PhD, MPH
University of Colorado, Denver
Outcome results
None listed