Type 1 Diabetes MellitusAHCLS T1D nutrNCT06848933
Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
A study testing Test meal, Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode and Advanced hybrid closed loop system mode in people with Type 1 Diabetes Mellitus and Adolescents, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Adolescents
- What is being tested?
- Test meal, Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode and Advanced hybrid closed loop system mode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 20 Dec 2024
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Volunteering to participate in the study
- Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)
Who cannot join
- - Not volunteering to participate in the study
- Using psychiatric medication or any medication that may cause obesity at the time of trial
- Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Medical Faculty, Division of Pediatric Endocrinology
Izmir, Bornova, 35100
About this study
AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals
Read the detailed description
On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.
- Conditions
- Type 1 Diabetes Mellitus, Adolescents
- Being tested
- Test meal, Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode, Advanced hybrid closed loop system mode
- Keywords
- AHCLS, type 1 diabetes, high fat, high protein, adolescents
- 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.
Test mealOther
On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous
Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual modeDevice
After the intervention, blood glucose values will be documented from continued glucose measurement system for postprandial 5 hours,and compared in manual mode and auto mode
Advanced hybrid closed loop system modeDevice
On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with type 1 diabetes on Medtronic Minimed 780G | Experimental | Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself Receives: Other: Test meal; Device: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode; Device: Advanced hybrid closed loop system mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal
Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test meal
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start5 Jan 2024
- Primary completion30 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Tinaztepe University
- Responsible party
- Principal investigator, Yasemin Atik Altinok, Izmir Tinaztepe University
- Investigators
- yasemin atik altınok, Assoc Prof, Principal investigator, İzmir Tınaztepe UniversityDamla Goksen, Prof Dr, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848933
- Sponsor's protocol ID
- AHCLS T1D high fat and protein
- Acronym
- AHCLS T1D nutr
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
- ClinicalTrials.gov ID
- NCT06848933
- Acronym / sponsor ID
- AHCLS T1D nutr / AHCLS T1D high fat and protein
- Conditions
- Type 1 Diabetes Mellitus, Adolescents
- Keywords
- AHCLS, type 1 diabetes, high fat, high protein, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Izmir Tinaztepe University
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Feb 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.
AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals
Detailed description
On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with type 1 diabetes on Medtronic Minimed 780G | Experimental | Other: Test meal, Device: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode, Device: Advanced hybrid closed loop system modeEach participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the study
- Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)
Key exclusion criteria (3 listed)
- - Not volunteering to participate in the study
- Using psychiatric medication or any medication that may cause obesity at the time of trial
- Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)
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 |
|---|---|---|
| Test mealOn days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous | Other | Adolescents with type 1 diabetes on Medtronic Minimed 780G |
| Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual modeAfter the intervention, blood glucose values will be documented from continued glucose measurement system for postprandial 5 hours,and compared in manual mode and auto mode | Device | Adolescents with type 1 diabetes on Medtronic Minimed 780G |
| Advanced hybrid closed loop system modeOn days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous | Device | Adolescents with type 1 diabetes on Medtronic Minimed 780G |
Primary outcome
time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal
Time frame: 1 month
Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test 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 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
yasemin atik altınok, Assoc Prof principal investigator
İzmir Tınaztepe University
Damla Goksen, Prof Dr study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal, Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode and Advanced hybrid closed loop system mode in people with Type 1 Diabetes Mellitus and Adolescents, run by Ege University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 27 Feb 2025. 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 Turkey (Türkiye). 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?
time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.