Type 1 Diabetes MellitusDIABETEXX/3NCT07278063
Impact of Dietary Fat and Menstrual Cycle Phases in Type 1 Diabetes
A study testing Low Fat Mixed Meal and High Fat Mixed Meal in people with Type 1 Diabetes Mellitus and Glycemic Variability, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
This clinical trial aims to evaluate how variations in dietary fat content and hormonal status influence postprandial glycemic response in individuals with type 1 diabetes (T1D), with a special focus on women. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Glycemic Variability, Sex Characteristics
- What is being tested?
- Low Fat Mixed Meal and High Fat Mixed Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- May 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a confirmed diagnosis of type 1 diabetes mellitus for more than 2 years, in treatment with AHCL (Advanced Hybrid Closed Loop) system treatment for at least 6 months.
- Both sexes.
- Metabolic control with HbA1c <8%.
- BMI between 18.5 and 29.99 (normal weight to overweight).
- For women: regular menstrual cycles (21-35 days in length with variation between cycles of <4 days) and no use of hormonal contraceptive treatment.
Who cannot join
- Diagnosis of diabetic gastroparesis.
- Presence of hypogonadism, anovulation, hyperandrogenism, hyperprolactinemia, pregnancy, or decompensated chronic diseases.
- Use of oral medications that alter glucose metabolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital la Fe
Valencia, Valencia, 46026
Olga Seguí, Medicine, +34680705127, oseguicot@gmail.com
Paolo Rossetti, Medicine, +34608109918, prossetti73@gmail.com
About this study
Official title: Effect of Gender and Meal Composition on the Postprandial Glycemic Response in People With Type 1 Diabetes: Impact of Fat Content and Menstrual Cycle Phases
This clinical trial aims to evaluate how variations in dietary fat content and hormonal status influence postprandial glycemic response in individuals with type 1 diabetes (T1D), with a special focus on women. The main objective is to clarify the impact of both factors individually and their interaction, which could inform more personalized strategies for insulin adjustment, optimizing glycemic control, and improving patient outcomes.
The main objective is to investigate the effects of low-fat versus high-fat meals, sex, menstrual cycle phases, and their interaction on postprandial glycemic control in adults with T1D treated with advanced hybrid closed-loop (AHCL) insulin delivery systems.
Read more
Specifically, the study will:
- Compare postprandial glycemic responses after standardized low and high-fat meals in men and women with T1D.
- Assess the differences in postprandial glycemic responses between early follicular and late luteal phases in women, using standardized meals with low and high fat content.
- Identify sex-related differences in glycemic response after equivalent meals.
This research addresses the unmet clinical need for precise, tailored postprandial insulin dosing recommendations, especially among women whose insulin sensitivity fluctuates with menstrual phases. The results may contribute to sex-specific predictive models in AHCL systems, reducing acute complications and improving overall quality of life.
This is a randomized controlled crossover trial in which each participant serves as her/his own control. Fifty adults will be enrolled: 25 women and 25 men. Women will undergo four mixed-meal tests in random order:
- low-fat given during the early follicular phase,
- high-fat given during the early follicular phase,
- low-fat given during the late luteal phase,
- high-fat given during the late luteal phase. The menstrual phase will be confirmed with home-based hormonal monitoring devices that function with urine sample and use a single-use test wand (MIRA system).
Men will complete two mixed-meal tests (low-fat and high-fat), in randomized order.
All meals will be standardized for carbohydrate content and matched in other macronutrients, except for fat (with a 30-40g difference), administered after an 8-hour fast. The day of the mixed meal test, AHCL systems will be switched from automatic to manual mode just before eating to standardize the prandial insulin dose and to avoid differences in insulin infusion rates in the postprandial state due to algorithm compensations. Continuous glucose monitoring (CGM) and hourly capillary glucose testing will measure the postprandial response. Additional fasting blood samples will assess metabolic, hormonal, and lipid markers. Optional gastric emptying studies may be performed to exclude confounding gastroparesis in selected patients.
Participants will be recruited from the endocrinology outpatient unit of La Fe Polytechnic University Hospital . The projected recruitment period is from December 2025 to July 2027, with mixed-meal tests and data collection occurring between January 2026 and December 2027. Women are expected to complete the protocol in 6 weeks (4 tests), while men will require about 2 weeks (2 tests).
At baseline, participants will undergo blood tests to rule out endocrine disorders and confirm sex hormone status. Women participating in the study will use the MIRA home device to monitor their hormonal levels, allowing them to accurately determine and record the phases of their menstrual cycle as part of the study protocol. During meal tests, CGM (Freestyle Libre 3) will be used uniformly among subjects.
The study dependent variables will be the following:
- Postprandial glucose area under the curve - AUC_PG_5h
- Mean glucose level - MG
- Continuous glucose monitoring metrics - TIR, TAR, TBR
- Postprandial glucose standard deviation - SD
- Postprandial glucose coefficient of variation - CV
- Mean amplitude of glycemic excursions - MAGE
- Mean of daily differences (MODD)
Independent variables are
- Type of food: Meals with either low or high fat content.
- Sex and Hormonal status: men; women during the early follicular phase; women during the late luteal phase.
If successful, this study will inform the development of more sophisticated, individualized insulin dosing algorithms and AHCL system improvements, especially for women with T1D. Results may lead to more effective management strategies, reduced GV, lower incidence of complications, and increased quality of life. Insights may directly support the personalization of diabetes care and improve gender equity in treatment standards.
Read the detailed description
Each female participant will initiate the protocol with the first mixed meal test during the luteal phase, using the MIRA home device to monitor their hormonal levels. This approach is intended to guarantee accurate assessment of menstruation, and assures the realization of the second mixed meal test in the subsequent follicular phase without interruption in all enrolled subjects..
The meaning of starting in the luteal phase is to avoid potential delays or absence of the menstrual cycle that could occur if randomization began in the follicular phase, which could render the planned sequence infeasible.
Randomization will be performed regarding the type of mixed meal administered: either high-fat or low-fat. Block randomization will be employed: 50% of participants commence with the low-fat meal, while the remaining 50% begin with the high-fat meal. This method is used to maintain balance between groups and to reduce allocation bias throughout the study.
The sample size calculation for this study was based on prior research evaluating postprandial glucose responses and the impact of menstrual cycle phases. Differences in glucose and glucose area under the curve (AUC) from mixed meals with varying fat content, as well as between menstrual phases, informed expected effect sizes. Assuming an intra-subject standard deviation of 25 mg/dl, a correlation of 0.5 between repeated measures, and an expected interaction effect of 20 mg/dl, a total of 50 participants (25 women and 25 men) is needed to achieve 80% statistical power with an alpha of 0.05. This ensures adequate power to detect meaningful differences in the postprandial glucose response measured by AUC according to meal fat content and menstrual cycle phase.
The study keeps the advanced hybrid closed-loop (AHCL) system active during the baseline period to maintain usual insulin delivery and ensure similar glucose concentrations just before the meal test and also during the previous hours. At the time of the mixed meal test, the system is switched to open-loop mode to standardize insulin dosing across all participants. This will prevent the pump from making automated insulin corrections to glucose excursions during the test, which would compensate, at least partially, the possible differences induced by the factors object of the investigation. The HCL systems will be maintained in the open-loop (manual) configuration from time 0 (prandial bolus administration) to the end of the study 5h after. The prandial insulin dose will be based on the usual individual insulin to carbohydrate ratio, while basal insulin will be infused at the planned safety mode rates (those rates programmed by the physician at which the systems infuse when it shift from the automatic to the manual mode). Importantly, both parameters (insulin to carbohydrate ratio and manual basal rates) will be optimized for each patient before the commencement of the meal tests and kept constant during the study participation.
This approach will help ensure similar preprandial glycemia between subjects, avoids confounding factors introduced by adaptive insulin delivery and will allow accurate assessment of the effects of meal composition and hormonal status on postprandial glucose response. Maintaining insulin dosing standardization is essential to isolate the variables under study without interference from the AHCL system's automatic glucose adjustments.
- Conditions
- Type 1 Diabetes Mellitus, Glycemic Variability, Sex Characteristics, Menstrual Cycle, Dietary Fat, Postprandial Glucose
- Being tested
- Low Fat Mixed Meal, High Fat Mixed Meal
- Keywords
- Type 1 diabetes, glycemic variability, advanced hybrid closed-loop systems, menstrual cycle, postprandial glucose, dietary fat, insulin sensitivity, continuous glucose monitoring, mixed-meal test, personalized insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat Mixed MealOther
The patients will eat a standardized meal designed to evaluate how their blood glucose responds to food intake under controlled conditions.
This meal contains a balanced proportion of carbohydrates, proteins, and a low fat content.
High Fat Mixed MealOther
The patients will eat a standardized meal designed to evaluate how their blood glucose responds to food intake under controlled conditions. This meal contains a balanced proportion of carbohydrates, proteins, and a high fat content.
| Study group | Role | What they receive |
|---|---|---|
| Female1 | Other | Female patients in early follicular phase Receives: Other: Low Fat Mixed Meal; Other: High Fat Mixed Meal |
| Female2 | Other | Female patients in late luteal phase Receives: Other: Low Fat Mixed Meal; Other: High Fat Mixed Meal |
| Male | Other | Male patients Receives: Other: Low Fat Mixed Meal; Other: High Fat Mixed Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose area under the curve (AUC_PG_5h)
Postprandial glucose effect of the interaction between fat intake and hormonal condition.
Difference in the area under de curve during 5 hour period as a function of the fat content of the meal and the hormonal condition, expressed in mg·h/dL:
Post prandial AUC_PG_5h in female subjects, follicular phase, low fat: FFL_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, follicular phase, high fat: FFH_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, luteal phase, low fat: FLL_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, luteal phase, high fat: FLH_AUC_PG_5h Post prandial AUC_PG_5h in male subjects, low fat: ML_AUC_PG_5h Post prandial AUC_PG_5h in male subjects, high fat: MH_AUC_PG_5h
Measured: 5 hours after each mixed-meal test.
Secondary outcomes (8)
Mean glucose level (MG)
Derived from CGM data, expressed in milligrams per deciliter (mg/dL).
Measured: 5 hours after mixed-meal test.
Time in range (TIR)
Derived from CGM data. Expressed as a percentage (%) of the time or readings with glucose values within the target range, typically between 70-180 mg/dL
Measured: 5 hours after mixed-meal test
Time above range (TAR)
Derived from CGM data. Expressed as a percentage (%) of the time or readings when glucose exceeds 180 mg/dL
Measured: 5 hours after mixed-meal test
Time below range (TBR)
Derived from CGM data. Expressed as a percentage (%) of the time or readings when glucose falls below 70 mg/dL
Measured: 5 hours after mixed-meal test
Postprandial glucose standard deviation (SD)
Derived from CGM data, expressed in milligrams per deciliter (mg/dL)
Measured: 5 hours after mixed-meal test.
Glycemic coefficient of variation (CV)
Derived from CGM data, expressed as a percentage (%), calculated as (SD / mean glucose) × 100
Measured: 5 hours after mixed-meal test
Mean amplitude of glycemic excursions (MAGE)
Derived from CGM data, expressed in milligrams per deciliter (mg/dL)
Measured: 5 hours post each mixed-meal
Mean of daily differences (MODD)
Calculated from CGM data as the average of absolute differences between glucose values at the same time on consecutive days, expressed in milligrams per deciliter (mg/dL).
Measured: 24-hour continuous glucose monitoring period before and after the mixed meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València, Hospital Universitario La Fe
- Responsible party
- Principal investigator, Paolo Rossetti, Instituto de Investigacion Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278063
- Sponsor's protocol ID
- 2025-0897-1
- Acronym
- DIABETEXX/3
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monroy G, Picon-Cesar MJ, Garcia-Aleman J, Tinahones FJ, Martinez-Montoro JI. Glycemic Control Across the Menstrual Cycle in Women with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System: The 780MENS Prospective Study. Diabetes Technol Ther. 2025 May;27(5):395-401. doi: 10.1089/dia.2024.0522. Epub 2025 Jan 16.
PubMed 39898554Mesa A, Sola C, Vinagre I, Roca D, Granados M, Pueyo I, Cabre C, Conget I, Gimenez M. Impact of an Advanced Hybrid Closed-Loop System on Glycemic Control Throughout the Menstrual Cycle in Women with Type 1 Diabetes Prone to Hypoglycemia. Diabetes Technol Ther. 2024 Sep;26(9):667-672. doi: 10.1089/dia.2023.0571. Epub 2024 May 10.
PubMed 38441905Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.
PubMed 35099294Trout KK, Rickels MR, Schutta MH, Petrova M, Freeman EW, Tkacs NC, Teff KL. Menstrual cycle effects on insulin sensitivity in women with type 1 diabetes: a pilot study. Diabetes Technol Ther. 2007 Apr;9(2):176-82. doi: 10.1089/dia.2006.0004.
PubMed 17425444Tatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443.
PubMed 35869507Brown SA, Jiang B, McElwee-Malloy M, Wakeman C, Breton MD. Fluctuations of Hyperglycemia and Insulin Sensitivity Are Linked to Menstrual Cycle Phases in Women With T1D. J Diabetes Sci Technol. 2015 Oct 14;9(6):1192-9. doi: 10.1177/1932296815608400.
PubMed 26468135Herranz L, Saez-de-Ibarra L, Hillman N, Gaspar R, Pallardo LF. [Glycemic changes during menstrual cycles in women with type 1 diabetes]. Med Clin (Barc). 2016 Apr 1;146(7):287-91. doi: 10.1016/j.medcli.2015.11.044. Epub 2016 Feb 18. Spanish.
PubMed 26897501Barata DS, Adan LF, Netto EM, Ramalho AC. The effect of the menstrual cycle on glucose control in women with type 1 diabetes evaluated using a continuous glucose monitoring system. Diabetes Care. 2013 May;36(5):e70. doi: 10.2337/dc12-2248. No abstract available.
PubMed 23613610Goldner WS, Kraus VL, Sivitz WI, Hunter SK, Dillon JS. Cyclic changes in glycemia assessed by continuous glucose monitoring system during multiple complete menstrual cycles in women with type 1 diabetes. Diabetes Technol Ther. 2004 Aug;6(4):473-80. doi: 10.1089/1520915041705875.
PubMed 15321002Gamarra E, Trimboli P. Menstrual Cycle, Glucose Control and Insulin Sensitivity in Type 1 Diabetes: A Systematic Review. J Pers Med. 2023 Feb 20;13(2):374. doi: 10.3390/jpm13020374.
PubMed 36836608Concepcion Zavaleta MJ, Gonzales Yovera JG, Moreno Marreros DM, Rafael Robles LDP, Palomino Taype KR, Soto Galvez KN, Arriola Torres LF, Coronado Arroyo JC, Concepcion Urteaga LA. Diabetic gastroenteropathy: An underdiagnosed complication. World J Diabetes. 2021 Jun 15;12(6):794-809. doi: 10.4239/wjd.v12.i6.794.
PubMed 34168729Horowitz M, O'Donovan D, Jones KL, Feinle C, Rayner CK, Samsom M. Gastric emptying in diabetes: clinical significance and treatment. Diabet Med. 2002 Mar;19(3):177-94. doi: 10.1046/j.1464-5491.2002.00658.x.
PubMed 11918620Aigner L, Becker B, Gerken S, Quast DR, Meier JJ, Nauck MA. Day-to-Day Variations in Fasting Plasma Glucose Do Not Influence Gastric Emptying in Subjects With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):479-488. doi: 10.2337/dc20-1660. Epub 2020 Dec 7.
PubMed 33288653Mashali G, Kaul A, Khoury J, Corsiglia J, Dolan LM, Shah AS. Screening for Gastric Sensory Motor Abnormalities in Pediatric Patients With Type 1 Diabetes. Endocr Pract. 2023 Mar;29(3):168-173. doi: 10.1016/j.eprac.2022.12.014. Epub 2022 Dec 23.
PubMed 36572278Bartholome R, Salden B, Vrolijk MF, Troost FJ, Masclee A, Bast A, Haenen GR. Paracetamol as a Post Prandial Marker for Gastric Emptying, A Food-Drug Interaction on Absorption. PLoS One. 2015 Sep 9;10(9):e0136618. doi: 10.1371/journal.pone.0136618. eCollection 2015.
PubMed 26352940
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gender and Meal Composition on the Postprandial Glycemic Response in People With Type 1 Diabetes: Impact of Fat Content and Menstrual Cycle Phases
- ClinicalTrials.gov ID
- NCT07278063
- Acronym / sponsor ID
- DIABETEXX/3 / 2025-0897-1
- Conditions
- Type 1 Diabetes Mellitus, Glycemic Variability, Sex Characteristics, Menstrual Cycle, Dietary Fat, Postprandial Glucose
- Keywords
- Type 1 diabetes, glycemic variability, advanced hybrid closed-loop systems, menstrual cycle, postprandial glucose, dietary fat, insulin sensitivity, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València, Hospital Universitario La Fe
- Study start
- May 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate how variations in dietary fat content and hormonal status influence postprandial glycemic response in individuals with type 1 diabetes (T1D), with a special focus on women. The main objective is to clarify the impact of both factors individually and their interaction, which could inform more personalized strategies for insulin adjustment, optimizing glycemic control, and improving patient outcomes.
The main objective is to investigate the effects of low-fat versus high-fat meals, sex, menstrual cycle phases, and their interaction on postprandial glycemic control in adults with T1D treated with advanced hybrid closed-loop (AHCL) insulin delivery systems.
Specifically, the study will:
- Compare postprandial glycemic responses after standardized low and high-fat meals in men and women with T1D.
- Assess the differences in postprandial glycemic responses between early follicular and late luteal phases in women, using standardized meals with low and high fat content.
- Identify sex-related differences in glycemic response after equivalent meals.
This research addresses the unmet clinical need for precise, tailored postprandial insulin dosing recommendations, especially among women whose insulin sensitivity fluctuates with menstrual phases. The results may contribute to sex-specific predictive models in AHCL systems, reducing acute complications and improving overall quality of life.
This is a randomized controlled crossover trial in which each participant serves as her/his own control. Fifty adults will be enrolled: 25 women and 25 men. Women will undergo four mixed-meal tests in random order:
- low-fat given during the early follicular phase,
- high-fat given during the early follicular phase,
- low-fat given during the late luteal phase,
- high-fat given during the late luteal phase. The menstrual phase will be confirmed with home-based hormonal monitoring devices that function with urine sample and use a single-use test wand (MIRA system).
Men will complete two mixed-meal tests (low-fat and high-fat), in randomized order.
All meals will be standardized for carbohydrate content and matched in other macronutrients, except for fat (with a 30-40g difference), administered after an 8-hour fast. The day of the mixed meal test, AHCL systems will be switched from automatic to manual mode just before eating to standardize the prandial insulin dose and to avoid differences in insulin infusion rates in the postprandial state due to algorithm compensations. Continuous glucose monitoring (CGM) and hourly capillary glucose testing will measure the postprandial response. Additional fasting blood samples will assess metabolic, hormonal, and lipid markers. Optional gastric emptying studies may be performed to exclude confounding gastroparesis in selected patients.
Participants will be recruited from the endocrinology outpatient unit of La Fe Polytechnic University Hospital . The projected recruitment period is from December 2025 to July 2027, with mixed-meal tests and data collection occurring between January 2026 and December 2027. Women are expected to complete the protocol in 6 weeks (4 tests), while men will require about 2 weeks (2 tests).
At baseline, participants will undergo blood tests to rule out endocrine disorders and confirm sex hormone status. Women participating in the study will use the MIRA home device to monitor their hormonal levels, allowing them to accurately determine and record the phases of their menstrual cycle as part of the study protocol. During meal tests, CGM (Freestyle Libre 3) will be used uniformly among subjects.
The study dependent variables will be the following:
- Postprandial glucose area under the curve - AUC_PG_5h
- Mean glucose level - MG
- Continuous glucose monitoring metrics - TIR, TAR, TBR
- Postprandial glucose standard deviation - SD
- Postprandial glucose coefficient of variation - CV
- Mean amplitude of glycemic excursions - MAGE
- Mean of daily differences (MODD)
Independent variables are
- Type of food: Meals with either low or high fat content.
- Sex and Hormonal status: men; women during the early follicular phase; women during the late luteal phase.
If successful, this study will inform the development of more sophisticated, individualized insulin dosing algorithms and AHCL system improvements, especially for women with T1D. Results may lead to more effective management strategies, reduced GV, lower incidence of complications, and increased quality of life. Insights may directly support the personalization of diabetes care and improve gender equity in treatment standards.
Detailed description
Each female participant will initiate the protocol with the first mixed meal test during the luteal phase, using the MIRA home device to monitor their hormonal levels. This approach is intended to guarantee accurate assessment of menstruation, and assures the realization of the second mixed meal test in the subsequent follicular phase without interruption in all enrolled subjects..
The meaning of starting in the luteal phase is to avoid potential delays or absence of the menstrual cycle that could occur if randomization began in the follicular phase, which could render the planned sequence infeasible.
Randomization will be performed regarding the type of mixed meal administered: either high-fat or low-fat. Block randomization will be employed: 50% of participants commence with the low-fat meal, while the remaining 50% begin with the high-fat meal. This method is used to maintain balance between groups and to reduce allocation bias throughout the study.
The sample size calculation for this study was based on prior research evaluating postprandial glucose responses and the impact of menstrual cycle phases. Differences in glucose and glucose area under the curve (AUC) from mixed meals with varying fat content, as well as between menstrual phases, informed expected effect sizes. Assuming an intra-subject standard deviation of 25 mg/dl, a correlation of 0.5 between repeated measures, and an expected interaction effect of 20 mg/dl, a total of 50 participants (25 women and 25 men) is needed to achieve 80% statistical power with an alpha of 0.05. This ensures adequate power to detect meaningful differences in the postprandial glucose response measured by AUC according to meal fat content and menstrual cycle phase.
The study keeps the advanced hybrid closed-loop (AHCL) system active during the baseline period to maintain usual insulin delivery and ensure similar glucose concentrations just before the meal test and also during the previous hours. At the time of the mixed meal test, the system is switched to open-loop mode to standardize insulin dosing across all participants. This will prevent the pump from making automated insulin corrections to glucose excursions during the test, which would compensate, at least partially, the possible differences induced by the factors object of the investigation. The HCL systems will be maintained in the open-loop (manual) configuration from time 0 (prandial bolus administration) to the end of the study 5h after. The prandial insulin dose will be based on the usual individual insulin to carbohydrate ratio, while basal insulin will be infused at the planned safety mode rates (those rates programmed by the physician at which the systems infuse when it shift from the automatic to the manual mode). Importantly, both parameters (insulin to carbohydrate ratio and manual basal rates) will be optimized for each patient before the commencement of the meal tests and kept constant during the study participation.
This approach will help ensure similar preprandial glycemia between subjects, avoids confounding factors introduced by adaptive insulin delivery and will allow accurate assessment of the effects of meal composition and hormonal status on postprandial glucose response. Maintaining insulin dosing standardization is essential to isolate the variables under study without interference from the AHCL system's automatic glucose adjustments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Female1 | Other | Other: Low Fat Mixed Meal, Other: High Fat Mixed MealFemale patients in early follicular phase |
| Female2 | Other | Other: Low Fat Mixed Meal, Other: High Fat Mixed MealFemale patients in late luteal phase |
| Male | Other | Other: Low Fat Mixed Meal, Other: High Fat Mixed MealMale patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a confirmed diagnosis of type 1 diabetes mellitus for more than 2 years, in treatment with AHCL (Advanced Hybrid Closed Loop) system treatment for at least 6 months.
- Both sexes.
- Metabolic control with HbA1c <8%.
- BMI between 18.5 and 29.99 (normal weight to overweight).
- For women: regular menstrual cycles (21-35 days in length with variation between cycles of <4 days) and no use of hormonal contraceptive treatment.
Key exclusion criteria (3 listed)
- Diagnosis of diabetic gastroparesis.
- Presence of hypogonadism, anovulation, hyperandrogenism, hyperprolactinemia, pregnancy, or decompensated chronic diseases.
- Use of oral medications that alter glucose metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Fat Mixed MealThe patients will eat a standardized meal designed to evaluate how their blood glucose responds to food intake under controlled conditions. This meal contains a balanced proportion of carbohydrates, proteins, and a low fat content. | Other | Female1, Female2, Male |
| High Fat Mixed MealThe patients will eat a standardized meal designed to evaluate how their blood glucose responds to food intake under controlled conditions. This meal contains a balanced proportion of carbohydrates, proteins, and a high fat content. | Other | Female1, Female2, Male |
Primary outcome
Postprandial glucose area under the curve (AUC_PG_5h)
Time frame: 5 hours after each mixed-meal test.
Postprandial glucose effect of the interaction between fat intake and hormonal condition. Difference in the area under de curve during 5 hour period as a function of the fat content of the meal and the hormonal condition, expressed in mg·h/dL: Post prandial AUC_PG_5h in female subjects, follicular phase, low fat: FFL_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, follicular phase, high fat: FFH_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, luteal phase, low fat: FLL_AUC_PG_5h Post prandial AUC_PG_5h in female subjects, luteal phase, high fat: FLH_AUC_PG_5h Post prandial AUC_PG_5h in male subjects, low fat: ML_AUC_PG_5h Post prandial AUC_PG_5h in male subjects, high fat: MH_AUC_PG_5h
8 secondary outcomes
Mean glucose level (MG)
Time frame: 5 hours after mixed-meal test.
Time in range (TIR)
Time frame: 5 hours after mixed-meal test
Time above range (TAR)
Time frame: 5 hours after mixed-meal test
Time below range (TBR)
Time frame: 5 hours after mixed-meal test
Postprandial glucose standard deviation (SD)
Time frame: 5 hours after mixed-meal test.
Glycemic coefficient of variation (CV)
Time frame: 5 hours after mixed-meal test
Mean amplitude of glycemic excursions (MAGE)
Time frame: 5 hours post each mixed-meal
Mean of daily differences (MODD)
Time frame: 24-hour continuous glucose monitoring period before and after the mixed meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 39898554Monroy G, Picon-Cesar MJ, Garcia-Aleman J, Tinahones FJ, Martinez-Montoro JI. Glycemic Control Across the Menstrual Cycle in Women with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System: The 780MENS Prospective Study. Diabetes Technol Ther. 2025 May;27(5):395-401. doi: 10.1089/dia.2024.0522. Epub 2025 Jan 16.
- Background: PubMed 38441905Mesa A, Sola C, Vinagre I, Roca D, Granados M, Pueyo I, Cabre C, Conget I, Gimenez M. Impact of an Advanced Hybrid Closed-Loop System on Glycemic Control Throughout the Menstrual Cycle in Women with Type 1 Diabetes Prone to Hypoglycemia. Diabetes Technol Ther. 2024 Sep;26(9):667-672. doi: 10.1089/dia.2023.0571. Epub 2024 May 10.
- Background: PubMed 35099294Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.
- Background: PubMed 17425444Trout KK, Rickels MR, Schutta MH, Petrova M, Freeman EW, Tkacs NC, Teff KL. Menstrual cycle effects on insulin sensitivity in women with type 1 diabetes: a pilot study. Diabetes Technol Ther. 2007 Apr;9(2):176-82. doi: 10.1089/dia.2006.0004.
- Background: PubMed 35869507Tatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443.
- Background: PubMed 26468135Brown SA, Jiang B, McElwee-Malloy M, Wakeman C, Breton MD. Fluctuations of Hyperglycemia and Insulin Sensitivity Are Linked to Menstrual Cycle Phases in Women With T1D. J Diabetes Sci Technol. 2015 Oct 14;9(6):1192-9. doi: 10.1177/1932296815608400.
- Background: PubMed 26897501Herranz L, Saez-de-Ibarra L, Hillman N, Gaspar R, Pallardo LF. [Glycemic changes during menstrual cycles in women with type 1 diabetes]. Med Clin (Barc). 2016 Apr 1;146(7):287-91. doi: 10.1016/j.medcli.2015.11.044. Epub 2016 Feb 18. Spanish.
- Background: PubMed 23613610Barata DS, Adan LF, Netto EM, Ramalho AC. The effect of the menstrual cycle on glucose control in women with type 1 diabetes evaluated using a continuous glucose monitoring system. Diabetes Care. 2013 May;36(5):e70. doi: 10.2337/dc12-2248. No abstract available.
- Background: PubMed 15321002Goldner WS, Kraus VL, Sivitz WI, Hunter SK, Dillon JS. Cyclic changes in glycemia assessed by continuous glucose monitoring system during multiple complete menstrual cycles in women with type 1 diabetes. Diabetes Technol Ther. 2004 Aug;6(4):473-80. doi: 10.1089/1520915041705875.
- Background: PubMed 36836608Gamarra E, Trimboli P. Menstrual Cycle, Glucose Control and Insulin Sensitivity in Type 1 Diabetes: A Systematic Review. J Pers Med. 2023 Feb 20;13(2):374. doi: 10.3390/jpm13020374.
- Background: PubMed 34168729Concepcion Zavaleta MJ, Gonzales Yovera JG, Moreno Marreros DM, Rafael Robles LDP, Palomino Taype KR, Soto Galvez KN, Arriola Torres LF, Coronado Arroyo JC, Concepcion Urteaga LA. Diabetic gastroenteropathy: An underdiagnosed complication. World J Diabetes. 2021 Jun 15;12(6):794-809. doi: 10.4239/wjd.v12.i6.794.
- Background: PubMed 11918620Horowitz M, O'Donovan D, Jones KL, Feinle C, Rayner CK, Samsom M. Gastric emptying in diabetes: clinical significance and treatment. Diabet Med. 2002 Mar;19(3):177-94. doi: 10.1046/j.1464-5491.2002.00658.x.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fat Mixed Meal and High Fat Mixed Meal in people with Type 1 Diabetes Mellitus and Glycemic Variability, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Rossetti, Medicine (+34608109913, rossetti_paolo@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose area under the curve (AUC_PG_5h) (time frame: 5 hours after each mixed-meal test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07278063, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.