Type 1 Diabetes MellitusNCT07786064
Comparative Study of the Postprandial Glycemic Profile After Consumption of a High-fat Meal (Pizza) Between the Open-loop System (Medtronic MiniMed 640G) and the Hybrid Closed-loop System (Medtronic MiniMed 780G) in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Pumps.
A study testing Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 h, Closed-loop standard insulin bolus strategy and Supplementary insulin bolus strategy in people with Type 1 Diabetes Mellitus, run by Konstantinos Makrilakis, MD at 1 site in Greece.
Trial summary
The aim of this interventional clinical study is to compare the postprandial glycemic profile of patients with type 1 diabetes using either an open-loop (Medtronic Minimed 640G) or closed-loop (Medtronic Minimed 780G) insulin pump, after consuming a high-fat meal (pizza). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 h, Closed-loop standard insulin bolus strategy and Supplementary insulin bolus strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jun 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 1 Diabetes (T1D) at least 12 months prior to study participation
- Use of continuous subcutaneous insulin infusion (CSII) pump for at least 6 months prior to enrollment ("trained" patients)
- Adequate glycemic control (recent HbA1c value ≤ 8%)
Who cannot join
- Known microvascular and macrovascular complications of diabetes
- History of gastroparesis or malabsorption
- History of stomach or intestinal surgery
- Use of medications that affect gastrointestinal motility (e.g., prokinetics, antiemetics, GLP-1 agonists, etc.)
- Known deficiency of fat-soluble vitamins (A, D, E, K)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Laboratory, 1st Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens Medical School, Laiko General Hospital, Athens, Greece
Athens, Athens, 11527
About this study
The aim of this interventional clinical study is to compare the postprandial glycemic profile of patients with type 1 diabetes using either an open-loop (Medtronic Minimed 640G) or closed-loop (Medtronic Minimed 780G) insulin pump, after consuming a high-fat meal (pizza). The new advanced Medtronic MiniMed 780G insulin pump (closed hybrid loop) features an advanced algorithm that enables the automatic administration of corrective microdoses of insulin (microboluses) every 5 minutes. The open-loop pump offers the option of a dual-wave bolus pattern for insulin delivery, which is currently considered the best approach for managing such high-fat meals, a feature that is not available in the closed-loop pump. The main questions to answer are:
- To what extent can the new closed-loop insulin pump with automatic corrective microdoses of insulin manage the late postprandial hyperglycemia caused by a high-fat meal like pizza, which is extremely difficult for type 1 diabetes patients to manage?
- To what extent should protein and fat, in addition to carbohydrates, be accounted for in patients with type 1 diabetes using the closed-loop pump when consuming high-fat meals like pizza? Participants will be adults (> 18years old) with type 1 diabetes using the MiniMed 780G pump (with either aspart or lispro insulin) and who are regularly followed up at the Insulin Pump Outpatient Department of the Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece. They will undergo three study visits. During these visits, different strategies for managing a high-fat meal will be compared using both the closed-loop and open-loop modes of the insulin pump. A brief clinical history will be taken (duration of diabetes, conditions at initial diagnosis, treatment regimen, complications), and anthropometric measurements (height, weight, waist circumference) will be recorded. Data from the insulin pumps will be uploaded to a computer to document the pump's basic settings (insulin-to-carbohydrate ratio, insulin sensitivity factor, hourly basal rates, glucose target, active insulin time), and the most recent HbA1c value will be noted. The meal test will start only if the sensor glucose level upon arrival is below 180 mg/dL. An intravenous catheter will be placed in a forearm vein for repeated blood sampling to measure venous glucose levels at time 0 (pre-meal), 30, 60, 90, 120, 150, 180, 210, and 240 minutes after consuming the meal. At the same times, capillary blood glucose will also be measured, the glucose sensor readings from the pump will be recorded as well. The meal test will then begin, using different meal coverage approaches to be compared.
Read the detailed description
Participants will consume a total of 250 g of pizza, (a "four cheese" type pizza with classic crust) with the following macronutrient composition by percentage: 37.9% fat, 41.07% carbohydrates and dietary fiber, and 21.01% protein, and it must be consumed within 10 minutes, with or without water. One tablespoon of olive oil will be added to the above meal to increase its fat content. After the addition of olive oil, the final meal composition in macronutrients will be as follows: 41.25 g fat (48.62% \& 366.25 kcal), 64 g carbohydrates (33.98% \& 256 kcal) and 32.75 g protein (17.39% \& 131 kcal. During the three different study visits, three different meal consumption management approaches will be applied. Given the ability of the 780G insulin pump to operate as a 640G pump, this enables a direct comparison of different fat-rich meal management approaches in the same patients using only one type of pump. In the first study visit, involving dual-wave insulin bolus in open-loop conditions, patients will exit the automatic mode of the 780G pump immediately prior to the meal test and enter open-loop mode using the pump as a 640G. The carbohydrate content of the meal (64 g) will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours. In the second study visit, involving a single insulin bolus in closed-loop conditions, only the carbohydrate grams of the meal will be declared (as fat and protein are not recommended to be included in the bolus calculation with the 780G pump). The pump will deliver a single bolus of insulin 10 minutes before the meal. In the third visit, participants will receive the same predetermined amount of pizza in closed-loop conditions. Ten minutes before the meal, 64 g of carbohydrates will be declared, and 1 hour after the meal has started, the insulin dose will be increased by 30% for fat and 20% for protein, a total of 50%, calculated based on 50% of the carbohydrate grams declared before the meal. The total and cumulative areas under the curve (AUC), reflecting postprandial glycemic levels for up to 4 hours post-meal, will be calculated and compared across the three approaches using non-inferiority statistical analysis. Additionally, sensor glucose data (measured every 5 minutes) will be collected for a total of up to 8 hours post-meal, to capture any differences in late postprandial hyperglycemic peaks. All participants will receive detailed verbal and written information about the study procedures and objectives and will sign an informed consent form.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 h, Closed-loop standard insulin bolus strategy, Supplementary insulin bolus strategy
- Keywords
- Diabetes Mellitus Type 1, Medtronic Minimed 780G, High-fat meal, carbohydrate-containing mixed meals
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 hOther
The carbohydrate content of the meal will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours. The meal bolus is calculated according to each participant's individual insulin-to-carbohydrate ratio.
Closed-loop standard insulin bolus strategyOther
Participants receive the standard meal insulin bolus for a standardized pizza meal while using the MiniMed 780G advanced hybrid closed-loop system. The meal bolus is calculated according to each participant's individual insulin-to-carbohydrate ratio.The pump will deliver a single bolus of insulin 10 minutes before the meal.
Supplementary insulin bolus strategyOther
Participants receive the standard meal insulin bolus for a standardized pizza meal while using the MiniMed 780G advanced hybrid closed-loop system, followed by a supplementary insulin bolus according to the predefined study protocol.
| Study group | Role | What they receive |
|---|---|---|
| open-loop dual-wave bolus, insulin increased by 50% for fat/protein, 50% upfront and 50% over 4h | Other | The carbohydrate content of the meal (64 g) will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours Receives: Other: Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 h |
| closed-loop standard carbohydrate-based bolus | Other | A single insulin bolus in closed-loop conditions, only the carbohydrate grams of the meal will be declared (as fat and protein are not recommended to be included in the bolus calculation with the 780G pump). The pump will deliver a single bolus of insulin 10 minutes before the meal. Receives: Other: Closed-loop standard insulin bolus strategy |
| closed-loop standard bolus plus 50% supplementary bolus 1 h after meal initiation | Other | Participants assigned to this sequence will receive the same predetermined amount of pizza in closed-loop conditions. Ten minutes before the meal, 64 g of carbohydrates will be declared, and 1 hour after the meal has started, the insulin dose will be increased by 30% for fat and 20% for protein, a total of 50%, calculated based on 50% of the carbohydrate grams declared before the meal Receives: Other: Supplementary insulin bolus strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Postprandial Glucose Incremental Area Under the Curve (iAUC)(mg·h/dL)
Measured: 0-4 hours after consumption of the standardized meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start30 Jun 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Model description
- The present study will be an open-label, randomized, controlled, cross-over intervention study involving persons with Diabetes Mellitus type 1. Participants will consume the same amount of a high-fat meal (pizza).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstantinos Makrilakis, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konstantinos Makrilakis, MD, National and Kapodistrian University of Athens
- Investigators
- Konstantinos Makrilakis, MD, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786064
- Sponsor's protocol ID
- 205/02.09.2024
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bell KJ, Fio CZ, Twigg S, Duke SA, Fulcher G, Alexander K, McGill M, Wong J, Brand-Miller J, Steil GM. Amount and Type of Dietary Fat, Postprandial Glycemia, and Insulin Requirements in Type 1 Diabetes: A Randomized Within-Subject Trial. Diabetes Care. 2020 Jan;43(1):59-66. doi: 10.2337/dc19-0687. Epub 2019 Aug 27.
PubMed 31455688Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
PubMed 25998293Smith TA, Marlow AA, King BR, Smart CE. Insulin strategies for dietary fat and protein in type 1 diabetes: A systematic review. Diabet Med. 2021 Nov;38(11):e14641. doi: 10.1111/dme.14641. Epub 2021 Jul 18.
PubMed 34251692Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009 Nov 1;3(6):1490-500. doi: 10.1177/193229680900300631.
PubMed 20144405Cavagnuolo L, Bozzetto L, Franco L, Costabile G, Riccardi G, Rivellese AA, Annuzzi G. Pizza Leavening Technique Influences Postprandial Glucose Response: A Randomized Controlled Trial in Patients With Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):e157-e158. doi: 10.2337/dc19-0778. Epub 2019 Aug 15. No abstract available.
PubMed 31416896
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Postprandial Glycemic Profile After Consumption of a High-fat Meal (Pizza) Between the Open-loop System (Medtronic MiniMed 640G) and the Hybrid Closed-loop System (Medtronic MiniMed 780G) in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Pumps.
- ClinicalTrials.gov ID
- NCT07786064
- Acronym / sponsor ID
- 205/02.09.2024
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus Type 1, Medtronic Minimed 780G, High-fat meal, carbohydrate-containing mixed meals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Konstantinos Makrilakis, MDUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 25 Aug 2026 (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.
The aim of this interventional clinical study is to compare the postprandial glycemic profile of patients with type 1 diabetes using either an open-loop (Medtronic Minimed 640G) or closed-loop (Medtronic Minimed 780G) insulin pump, after consuming a high-fat meal (pizza). The new advanced Medtronic MiniMed 780G insulin pump (closed hybrid loop) features an advanced algorithm that enables the automatic administration of corrective microdoses of insulin (microboluses) every 5 minutes. The open-loop pump offers the option of a dual-wave bolus pattern for insulin delivery, which is currently considered the best approach for managing such high-fat meals, a feature that is not available in the closed-loop pump. The main questions to answer are:
- To what extent can the new closed-loop insulin pump with automatic corrective microdoses of insulin manage the late postprandial hyperglycemia caused by a high-fat meal like pizza, which is extremely difficult for type 1 diabetes patients to manage?
- To what extent should protein and fat, in addition to carbohydrates, be accounted for in patients with type 1 diabetes using the closed-loop pump when consuming high-fat meals like pizza? Participants will be adults (> 18years old) with type 1 diabetes using the MiniMed 780G pump (with either aspart or lispro insulin) and who are regularly followed up at the Insulin Pump Outpatient Department of the Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece. They will undergo three study visits. During these visits, different strategies for managing a high-fat meal will be compared using both the closed-loop and open-loop modes of the insulin pump. A brief clinical history will be taken (duration of diabetes, conditions at initial diagnosis, treatment regimen, complications), and anthropometric measurements (height, weight, waist circumference) will be recorded. Data from the insulin pumps will be uploaded to a computer to document the pump's basic settings (insulin-to-carbohydrate ratio, insulin sensitivity factor, hourly basal rates, glucose target, active insulin time), and the most recent HbA1c value will be noted. The meal test will start only if the sensor glucose level upon arrival is below 180 mg/dL. An intravenous catheter will be placed in a forearm vein for repeated blood sampling to measure venous glucose levels at time 0 (pre-meal), 30, 60, 90, 120, 150, 180, 210, and 240 minutes after consuming the meal. At the same times, capillary blood glucose will also be measured, the glucose sensor readings from the pump will be recorded as well. The meal test will then begin, using different meal coverage approaches to be compared.
Detailed description
Participants will consume a total of 250 g of pizza, (a "four cheese" type pizza with classic crust) with the following macronutrient composition by percentage: 37.9% fat, 41.07% carbohydrates and dietary fiber, and 21.01% protein, and it must be consumed within 10 minutes, with or without water. One tablespoon of olive oil will be added to the above meal to increase its fat content. After the addition of olive oil, the final meal composition in macronutrients will be as follows: 41.25 g fat (48.62% \& 366.25 kcal), 64 g carbohydrates (33.98% \& 256 kcal) and 32.75 g protein (17.39% \& 131 kcal. During the three different study visits, three different meal consumption management approaches will be applied. Given the ability of the 780G insulin pump to operate as a 640G pump, this enables a direct comparison of different fat-rich meal management approaches in the same patients using only one type of pump. In the first study visit, involving dual-wave insulin bolus in open-loop conditions, patients will exit the automatic mode of the 780G pump immediately prior to the meal test and enter open-loop mode using the pump as a 640G. The carbohydrate content of the meal (64 g) will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours. In the second study visit, involving a single insulin bolus in closed-loop conditions, only the carbohydrate grams of the meal will be declared (as fat and protein are not recommended to be included in the bolus calculation with the 780G pump). The pump will deliver a single bolus of insulin 10 minutes before the meal. In the third visit, participants will receive the same predetermined amount of pizza in closed-loop conditions. Ten minutes before the meal, 64 g of carbohydrates will be declared, and 1 hour after the meal has started, the insulin dose will be increased by 30% for fat and 20% for protein, a total of 50%, calculated based on 50% of the carbohydrate grams declared before the meal. The total and cumulative areas under the curve (AUC), reflecting postprandial glycemic levels for up to 4 hours post-meal, will be calculated and compared across the three approaches using non-inferiority statistical analysis. Additionally, sensor glucose data (measured every 5 minutes) will be collected for a total of up to 8 hours post-meal, to capture any differences in late postprandial hyperglycemic peaks. All participants will receive detailed verbal and written information about the study procedures and objectives and will sign an informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The present study will be an open-label, randomized, controlled, cross-over intervention study involving persons with Diabetes Mellitus type 1. Participants will consume the same amount of a high-fat meal (pizza).
| Arm | Type | Receives |
|---|---|---|
| open-loop dual-wave bolus, insulin increased by 50% for fat/protein, 50% upfront and 50% over 4h | Other | Other: Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 hThe carbohydrate content of the meal (64 g) will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours |
| closed-loop standard carbohydrate-based bolus | Other | Other: Closed-loop standard insulin bolus strategyA single insulin bolus in closed-loop conditions, only the carbohydrate grams of the meal will be declared (as fat and protein are not recommended to be included in the bolus calculation with the 780G pump). The pump will deliver a single bolus of insulin 10 minutes before the meal. |
| closed-loop standard bolus plus 50% supplementary bolus 1 h after meal initiation | Other | Other: Supplementary insulin bolus strategyParticipants assigned to this sequence will receive the same predetermined amount of pizza in closed-loop conditions. Ten minutes before the meal, 64 g of carbohydrates will be declared, and 1 hour after the meal has started, the insulin dose will be increased by 30% for fat and 20% for protein, a total of 50%, calculated based on 50% of the carbohydrate grams declared before the meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Type 1 Diabetes (T1D) at least 12 months prior to study participation
- Use of continuous subcutaneous insulin infusion (CSII) pump for at least 6 months prior to enrollment ("trained" patients)
- Adequate glycemic control (recent HbA1c value ≤ 8%)
Key exclusion criteria (5 listed)
- Known microvascular and macrovascular complications of diabetes
- History of gastroparesis or malabsorption
- History of stomach or intestinal surgery
- Use of medications that affect gastrointestinal motility (e.g., prokinetics, antiemetics, GLP-1 agonists, etc.)
- Known deficiency of fat-soluble vitamins (A, D, E, K)
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 |
|---|---|---|
| Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 hThe carbohydrate content of the meal will be declared, and the meal insulin dose will be increased by 30% for fat and 20% for protein, a total increase of 50%. The dual-wave bolus pattern of insulin delivery will be used: 50% of the recommended dose will be given 10 minutes before the meal, and the remaining 50% will be delivered as an extended bolus over the next 4 hours. The meal bolus is calculated according to each participant's individual insulin-to-carbohydrate ratio. | Other | open-loop dual-wave bolus, insulin increased by 50% for fat/protein, 50% upfront and 50% over 4h |
| Closed-loop standard insulin bolus strategyParticipants receive the standard meal insulin bolus for a standardized pizza meal while using the MiniMed 780G advanced hybrid closed-loop system. The meal bolus is calculated according to each participant's individual insulin-to-carbohydrate ratio.The pump will deliver a single bolus of insulin 10 minutes before the meal. | Other | closed-loop standard carbohydrate-based bolus |
| Supplementary insulin bolus strategyParticipants receive the standard meal insulin bolus for a standardized pizza meal while using the MiniMed 780G advanced hybrid closed-loop system, followed by a supplementary insulin bolus according to the predefined study protocol. | Other | closed-loop standard bolus plus 50% supplementary bolus 1 h after meal initiation |
Primary outcome
Serum Postprandial Glucose Incremental Area Under the Curve (iAUC)(mg·h/dL)
Time frame: 0-4 hours after consumption of the standardized meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 31455688Bell KJ, Fio CZ, Twigg S, Duke SA, Fulcher G, Alexander K, McGill M, Wong J, Brand-Miller J, Steil GM. Amount and Type of Dietary Fat, Postprandial Glycemia, and Insulin Requirements in Type 1 Diabetes: A Randomized Within-Subject Trial. Diabetes Care. 2020 Jan;43(1):59-66. doi: 10.2337/dc19-0687. Epub 2019 Aug 27.
- Background: PubMed 25998293Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
- Background: PubMed 34251692Smith TA, Marlow AA, King BR, Smart CE. Insulin strategies for dietary fat and protein in type 1 diabetes: A systematic review. Diabet Med. 2021 Nov;38(11):e14641. doi: 10.1111/dme.14641. Epub 2021 Jul 18.
- Background: PubMed 20144405Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009 Nov 1;3(6):1490-500. doi: 10.1177/193229680900300631.
- Background: PubMed 31416896Cavagnuolo L, Bozzetto L, Franco L, Costabile G, Riccardi G, Rivellese AA, Annuzzi G. Pizza Leavening Technique Influences Postprandial Glucose Response: A Randomized Controlled Trial in Patients With Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):e157-e158. doi: 10.2337/dc19-0778. Epub 2019 Aug 15. No abstract available.
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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. This study is not recruiting at the moment.
Konstantinos Makrilakis, MD, PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-loop dual-wave bolus, with insulin dose increased by 50% for fat/protein and delivered 50% upfront, 50% over 4 h, Closed-loop standard insulin bolus strategy and Supplementary insulin bolus strategy in people with Type 1 Diabetes Mellitus, run by Konstantinos Makrilakis, MD at 1 site in Greece.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 25 Aug 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Postprandial Glucose Incremental Area Under the Curve (iAUC)(mg·h/dL) (time frame: 0-4 hours after consumption of the standardized meal). 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 NCT07786064, which also lists 5 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 25 Aug 2026.