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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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This research study is designed to look at differences in responsiveness to the subcutaneous injection of a standardized dose of rapid-acting insulin analog and blood glucose variability during different phases of the menstrual cycle in females with type 1 diabetes (T1D).
Type 1 Diabetes (T1D) is a chronic disease that leads to disability and premature death if not well treated. While females and males are equally affected by T1D, diabetes places additional burdens of care on females. Characteristically, females with T1D have worse glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of cardiovascular complications as compared to their male peers. It has been hypothesized that variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is an important underlying cause for increased management problems in females with T1D, but the hypothesis has not been adequately tested. Consequently, insulin treatment of females during the different cycles of menstruation remains a guessing game that often results in major swings in blood glucose from high to low levels. The unfavorable impact of this gap in knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (CL) system insulin delivery algorithms designed based on insulin action parameters. The proposed study addresses this unmet need in diabetes management for females both in open-loop (OL) and CL therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| luteal phase clamp | Experimental | Luteal euglycemic clamp administered during luteal phase of menstrual cycle. |
|
| follicular phase clamp | Active Comparator | Follicular euglycemic clamp administered during follicular phase of menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follicular Euglycemic clamp | Device | Follicular Euglycemic clamp during follicular phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in area under the glucose infusion rate (AUCGIR) during different phases of menstrual cycle | The insulin glucodynamic action will be measured by the amount of dextrose infused during the study as previously described by DeFronzo. The primary outcome measure for the euglycemic clamp studies will be area under the glucose infusion rate (AUCGIR) that will be compared between luteal and follicular phases of menstrual cycle. | Up to 30 days |
| Glucose Infusion Rate | During the luteal phase of the menstrual cycle, subjects will go through an insulin time action (clamp) study. Subjects are injected a bolus dose of insulin and blood sugar levels are kept within a 90-100mg/dL range by intravenous fluid infusion during fasting state. GIR stands for the glucose infusion rate that is measured in mg/kg/minute, indicating the amount of glucose delivered per minute per kilogram of body mass. | Up to 15 days |
| Glucose Infusion Rate | During the follicular phase of the menstrual cycle, subjects will go through an insulin time action (clamp) study. Subjects are injected a bolus dose of insulin and blood sugar levels are kept within a 90-100mg/dL range by intravenous fluid infusion during fasting state. GIR stands for the glucose infusion rate that is measured in mg/kg/minute, indicating the amount of glucose delivered per minute per kilogram of body mass. | Up to 15 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | Glycemic variability measured by Continuous Glucose Monitor during two different phases of menstrual cycle will be investigated. | Up to 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eda Cengiz, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35714349 | Derived | Diaz C JL, Fabris C, Breton MD, Cengiz E. Insulin Replacement Across the Menstrual Cycle in Women with Type 1 Diabetes: An In Silico Assessment of the Need for Ad Hoc Technology. Diabetes Technol Ther. 2022 Nov;24(11):832-841. doi: 10.1089/dia.2022.0154. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Luteal Euglycemic clamp | Device | Luteal Euglycemic clamp during luteal phase |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |