Trial Outcomes & Findings for Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes (NCT NCT01653210)

Results Overview

Measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia. Our primary outcome measure is hyperglycemia risk during the luteal phase of the menstrual cycle. The primary hypothesis is there is an increased hyperglycemia risk during the luteal phase when compared to the follicular phase. Subjects will be compared to themselves across the three menstrual cycles captured. Hyperglycemia will be primarily assessed by high blood glucose index which was assessed over 3 menstrual cycles at specific time points in the cycle.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

Three menstrual cycles (average length of one cycle was 28.7 days)

Results posted on

2020-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Female T1DM Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Female T1DM n=12 Participants Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.1 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three menstrual cycles (average length of one cycle was 28.7 days)

Measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia. Our primary outcome measure is hyperglycemia risk during the luteal phase of the menstrual cycle. The primary hypothesis is there is an increased hyperglycemia risk during the luteal phase when compared to the follicular phase. Subjects will be compared to themselves across the three menstrual cycles captured. Hyperglycemia will be primarily assessed by high blood glucose index which was assessed over 3 menstrual cycles at specific time points in the cycle.

Outcome measures

Outcome measures
Measure	Female T1DM n=12 Participants Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
High Blood Glucose Index (HBGI) Early Follicular	6.87 index score Standard Error 0.88
High Blood Glucose Index (HBGI) Mid-Late Follicular	8.05 index score Standard Error 1.08
High Blood Glucose Index (HBGI) Peri-Ovulation	7.92 index score Standard Error 1.13
High Blood Glucose Index (HBGI) Early Luteal	9.00 index score Standard Error 1.25
High Blood Glucose Index (HBGI) Mid Luteal	8.02 index score Standard Error 0.99
High Blood Glucose Index (HBGI) Late Luteal	7.50 index score Standard Error 0.91

SECONDARY outcome

Timeframe: Three Menstrual Cycles

Changes in estrogen and progesterone will be primary drivers of hyperglycemia risk during the luteal phase. These data will be analyzed as continuous variables.

Outcome measures

Outcome measures
Measure	Female T1DM n=12 Participants Premenopausal women with menstrual cycles, 18-55 years of age, who have been diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is prohibited.
Glycemic Changes During Luteal Phase Estradiol: Early Follicular	41.34 pg/mL Standard Error 3.7
Glycemic Changes During Luteal Phase Estradiol: Mid-late Follicular	91.79 pg/mL Standard Error 13.77
Glycemic Changes During Luteal Phase Estradiol: Periovulation	225.06 pg/mL Standard Error 43.69
Glycemic Changes During Luteal Phase Estradiol: Mid-Luteal	213.33 pg/mL Standard Error 23.15
Glycemic Changes During Luteal Phase Estradiol: Late Luteal	143.81 pg/mL Standard Error 15.19

Adverse Events

Female T1DM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sue Brown, MD

Univerisity of Virginia

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place