Diabetes Mellitus, Type I, Menstruation
Conditions
Brief summary
Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.
Interventions
OTHERAerobic session
This session will consist of an aerobic training session performed on a cycle ergometer.
OTHERHIIT session
The HIIT exercise will consist of strength exercises with elastic bands.
Sponsors
European Regional Development Fund
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Six interventions will be carried out in a single group, being three aerobic sessions, two in two luteal phases and another in follicular phase, and other three session of high intensity interval exercise (HIIT).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) \< 8.5% (\<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.
Exclusion criteria
Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean interstitial glucose | 24 hours pre-intervention and 24 hours post-intervention | Mean interstitial glucose (mg/dL) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions. |
| Glycemic variability | 24 hours pre-intervention and 24 hours post-intervention | Glycemic variability (measured using the Coefficient of Variation-CV) will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions. |
| Time spent at each glucose range | 24 hours pre-intervention and 24 hours post-intervention | Time spent at each glucose range \[euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (\<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (\>250 mg/dL)\] will be measured using the FreeStyle3 as a continuous glucose meter during 6 hours, 12 hours, and 24 hours before and after both exercise sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oestrogens | pre-intervention | Estradiol levels (pg/ml) will be measured through blood extractions and subsequent analysis in the laboratory. |
| Progesterone | Pre-intervention | Progesterone (ng/mL) will be measured through blood extractions and subsequent analysis in the laboratory. |
Countries
Spain
Contacts
Primary ContactRodrigo Martín-San Agustín, Dr.
Outcome results
None listed