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| Name | Class |
|---|---|
| The Danish Diabetes Association | OTHER |
| Heart and Diabetes Center North Rhine-Westphalia | OTHER |
| University of Bristol | OTHER |
| Emory University |
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Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with T1D | Women living with T1D who are willing to share their diabetes management and menstrual cycle data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational prospective longitudinal data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify clusters in trajectories across the menstrual cycle |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness. | 2. Manual Insulin Adjustment Techniques:
| 6 months |
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Inclusion criteria:
Exclusion criteria:
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People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Hossmann, MSc | Contact | +41794217376 | stefanie.hossmann@dcberne.com | |
| Martina Rothenbühler, PhD | Contact | martina.rothenbuehler@dcberne.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCB Research AG | Recruiting | Bern | 3010 | Switzerland |
We plan to share the data but haven't specified the details yet.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle |
Identification and characterization of distinct clusters in glycemic metrics, insulin administration and insulin sensitivity representing unique patterns across distinct menstrual cycle phases (early follicular phase, late follicular phase, peri-ovulation, early luteal, mid luteal and late luteal phase) |
| 6 months |
| To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints. | Predictive Factors: o Identification of demographic, clinical, or physiological predictors (e.g., premenstrual cycle syndrome (PMS) score or age group) that significantly correlate with primary outcomes. | 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |