Diabetes Mellitus, Type 1NCT05899166
Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
A study testing Ketogenic diet, food delivery and education and Standard diet, food delivery and education in people with Diabetes Mellitus, Type 1, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? Does a ketogenic diet improve diabetes… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Ketogenic diet, food delivery and education and Standard diet, food delivery and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 30 Apr 2029
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 12 years.
- Within 3 month of diabetes diagnosis.
- Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis.
- Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker [glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin [prior to first insulin dose]; age under 10 years, BMI <95th percentile.
- Family committed and able to participate in study education and implement dietary intervention.
Who cannot join
- Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic).
- Eating disorders as assessed by Chede-Q8.
- Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables.
- Major psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Belinda Lennerz
About this study
Official title: Effect of Dietary Carbohydrate on Diabetes Control and Beta Cell Function in Children With Newly Diagnosed Diabetes
The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are:
- Does a ketogenic diet prolong the honeymoon period of type 1 diabetes?
- Does a ketogenic diet improve diabetes control?
- Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes?
- What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function?
Read more
Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months.
- Diabetes care devices will be connected for cloud-based data collection.
- Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns.
- During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes.
- Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life.
- Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.
Comparison will be made between a ketogenic vs standard diet.
Read the detailed description
Type I diabetes is caused by an autoimmune destruction of insulin producing β-cells in the pancreas, resulting in absolute insulin deficiency. In the first months after diagnosis, a small number of β-cells typically remain and, by producing insulin, significantly improve diabetes control and reduce disease burden.
Preliminary data suggest that this early disease stage entitled the "honeymoon period" might be extended by a ketogenic diet, which would provide a major therapeutic advantage and may reduce chronic disease burden.
To test the hypothesis that a ketogenic vs. standard diet will extend the honeymoon period and improve diabetes control in children, the researchers are conducting a study employing education and food deliveries of a ketogenic or standard diet to children and their families. Fifty-two children aged 5 to 12 years with newly diagnosed diabetes will participate. Children will be assigned by chance (randomized) to receive either a ketogenic or a standard diet for 9 months. Chances to be assigned to either diet are 50:50 like a coin flip, and 26 children will participate in each diet arm.
Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education throughout the 9 months. Continuous glucose monitoring (CGM) and diaries will be used for cloud-based data collection. Bi-weekly data downloads and remote check-ins will be performed to assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. Participants are instructed to measure blood ketone levels with their home ketone meter anytime blood glucose levels exceed a safety threshold and to call the study physician for persistent low glucose levels or ketones above diet specific safety thresholds.
Study visits are held at at baseline, 1, 5, and 9 months to collect height, weight, stool and blood samples for hormones, metabolites and inflammatory biomarkers. At each visit, an intravenous catheter (IV) will be placed to collect fasting blood samples, followed by a liquid test meal (protein shake) and collection of four additional blood samples from the IV over the course of two hours. Prior to each visit, participants will collect stool samples at home using provided kits. In addition, participants and their families may be invited to participate in a semi-structured interview, and online questionnaires to asses their food intake, experience with the diet, diabetes care burden and complications, and general well-being and quality of life. They may also be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Ketogenic diet, food delivery and education, Standard diet, food delivery and education
- Keywords
- carbohydrate reduced, low-carb, diabetes, keto
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet, food delivery and educationOther
Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.
Standard diet, food delivery and educationOther
Meals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively.
| Study group | Role | What they receive |
|---|---|---|
| ketogenic diet | Experimental | The diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be ~ 5% carbohydrate, 20% protein, 70% fat.
Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet. Receives: Other: Ketogenic diet, food delivery and education |
| standard diet | Active comparator | The diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be ~50% carbohydrate (<10% added sugars), 20% protein, 30% fat.
Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency. Receives: Other: Standard diet, food delivery and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in Beta-cell Function
Change in C-peptide 2-h area under the curve after a mixed-meal tolerance test (ΔCP).
Measured: Change over 1, 5, and 9 months, corrected for baseline
Secondary outcomes (28)
Time in Range (TIR) 70-180 mg/dl
From continuous glucose monitoring (CGM) - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Duration of Clinical Diabetes Remission
Calculated based on percent children with insulin dose corrected HbA1c (IDAA1c) <9.
Measured: 1, 5, 9, and optional at 24 months
Time in low Range (TIR) <70 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Time in very low Range (TIR) <55 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Time in high Range (TIR) >180 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation 2-week increments.
Measured: Over 9 months and optional at 24 months
Time in very high Range (TIR) >250 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Average Blood Glucose
From CGM - will be computed throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Coefficient of Glycemic Variation (CV)
From CGM - will be computed by dividing glucose standard deviation by glucose average throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Mean Amplitude of Glycemic Excursions (MAGE)
From CGM - will be computed using published formula throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
Total Daily Insulin Dose
From insulin administration device uploads - will be computed in units per kg throughout study participation in 2-week increments.
Measured: Over 9 months and optional at 24 months
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Calculated from fasting blood draw [fasting insulin (µU/ml) × fasting plasma glucose (mg/dl)]/405.
Measured: 1, 5, 9, and optional at 24 months
BMI
Weight divided by height squared.
Measured: 1, 5, 9, and optional at 24 months
Lipid panel
Fasting blood - total, LDL and HDL cholesterol, and triglycerides.
Measured: 1, 5, 9, and optional at 24 months
HDL to Triglyceride Ratio
Fasting blood
Measured: 1, 5, 9, and optional at 24 months
Lipoprotein Subfractions
Fasting blood
Measured: 1, 5, 9, and optional at 24 months
Inflammasome, targeted
Interleukins 1β, 17, 23, 6, 10; high sensitivity c-reactive protein; tumor necrosis factor α, interferon gamma
Measured: 1, 5, 9, and optional at 24 months
Microbiome, targeted and untargeted
Extraction and sequencing will be performed by Qiagen PowerSoil DNA extraction using Qiagen's DNeasy 96 PowerSoil Pro QIAcube HT Kit (480), followed by whole genome sequencing (WGS) using a miniaturized version of the NEBNext Ultra FS II method.
Measured: 1, 5, 9, and optional at 24 months
Metabolome, targeted and untargeted
Blood samples will be processed using liquid chromatography-mass spectrometry (LC-MS) and nuclear magnetic resonance (NMR). The LC-MS analyses will be carried out on a Sciex triple quadrupole mass spectrometer couple to an Exion ultra-performance LC system. The targeted analysis will utilize the Biocrates Q500 targeted metabolomics assay which quantifies more than 500 metabolites over 26 chemical classes (Biocrates Inc., Innsbruck, Austria). Data processing to yield metabolite concentrations in micromolar units will utilize the Biocrates MetIDQ software. The NMR data will be acquired on a Bruker Avance NEO 700 MHz NMR equipped with a TCI cryoprobe and a SampleXPress automatic sample changer. The data will be processed using the Chenomx NMR Processor and Profiler packages (Chenomx, Edmonton, CA) to yield quantitative data in millimolar units.
Measured: 1, 5, 9, and optional at 24 months
Problem Areas in Diabetes (PAID-Ped) - child
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate greater burden.
Measured: 1, 5, 9, and optional at 24 months
Problem Areas in Diabetes (PAID-PR) - parent
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate greater burden.
Measured: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) General Module - parent
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate better quality of life.
Measured: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) General Module - child
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate better quality of life.
Measured: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) Diabetes Module - parent
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate less problems.
Measured: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) Diabetes Module - child
Validated questionnaire, scored according to published standards. Scores range 0-100, higher scores indicate less problems.
Measured: 1, 5, 9, and optional at 24 months
Child Eating Disorder Examination Questionnaire (ChEDE-Q8)
Validated questionnaire, scored according to published standards. Scores range 0-42, higher scores are worse.
Measured: 1, 5, 9, and optional at 24 months
Perceptions on Diet Management of Diabetes
Questionnaire to assess participants' and caregivers' perceptions of the influence of the diet on their diabetes management.
Measured: 1, 5, 9, and optional at 24 months
Qualitative patient perspectives, interview - parent
Interviews will be held with children and caregivers separately after implementation and completion of the intervention.
Measured: optional at 9 months
Qualitative patient perspectives, interview - child
Interviews will be held with children and caregivers separately after implementation and completion of the intervention.
Measured: optional at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start31 May 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Indiana University
- Responsible party
- Principal investigator, Belinda Lennerz, Boston Children's Hospital
- Investigators
- Belinda Lennerz, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899166
- Sponsor's protocol ID
- IRB-P00044330
- Status last verified
- Apr 2025
- First submitted
- 1 Feb 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication, de-identified raw data for each original article will be uploaded to the appropriate an NIH maintained repository.
Publications
Lennerz BS, Koutnik AP, Azova S, Wolfsdorf JI, Ludwig DS. Carbohydrate restriction for diabetes: rediscovering centuries-old wisdom. J Clin Invest. 2021 Jan 4;131(1):e142246. doi: 10.1172/JCI142246.
PubMed 33393511Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.
PubMed 29735574
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Carbohydrate on Diabetes Control and Beta Cell Function in Children With Newly Diagnosed Diabetes
- ClinicalTrials.gov ID
- NCT05899166
- Acronym / sponsor ID
- IRB-P00044330
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- carbohydrate reduced, low-carb, diabetes, keto
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- University of South Florida, Indiana University
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 12 Jun 2023 (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 goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are:
- Does a ketogenic diet prolong the honeymoon period of type 1 diabetes?
- Does a ketogenic diet improve diabetes control?
- Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes?
- What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function?
Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months.
- Diabetes care devices will be connected for cloud-based data collection.
- Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns.
- During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes.
- Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life.
- Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.
Comparison will be made between a ketogenic vs standard diet.
Detailed description
Type I diabetes is caused by an autoimmune destruction of insulin producing β-cells in the pancreas, resulting in absolute insulin deficiency. In the first months after diagnosis, a small number of β-cells typically remain and, by producing insulin, significantly improve diabetes control and reduce disease burden.
Preliminary data suggest that this early disease stage entitled the "honeymoon period" might be extended by a ketogenic diet, which would provide a major therapeutic advantage and may reduce chronic disease burden.
To test the hypothesis that a ketogenic vs. standard diet will extend the honeymoon period and improve diabetes control in children, the researchers are conducting a study employing education and food deliveries of a ketogenic or standard diet to children and their families. Fifty-two children aged 5 to 12 years with newly diagnosed diabetes will participate. Children will be assigned by chance (randomized) to receive either a ketogenic or a standard diet for 9 months. Chances to be assigned to either diet are 50:50 like a coin flip, and 26 children will participate in each diet arm.
Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education throughout the 9 months. Continuous glucose monitoring (CGM) and diaries will be used for cloud-based data collection. Bi-weekly data downloads and remote check-ins will be performed to assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. Participants are instructed to measure blood ketone levels with their home ketone meter anytime blood glucose levels exceed a safety threshold and to call the study physician for persistent low glucose levels or ketones above diet specific safety thresholds.
Study visits are held at at baseline, 1, 5, and 9 months to collect height, weight, stool and blood samples for hormones, metabolites and inflammatory biomarkers. At each visit, an intravenous catheter (IV) will be placed to collect fasting blood samples, followed by a liquid test meal (protein shake) and collection of four additional blood samples from the IV over the course of two hours. Prior to each visit, participants will collect stool samples at home using provided kits. In addition, participants and their families may be invited to participate in a semi-structured interview, and online questionnaires to asses their food intake, experience with the diet, diabetes care burden and complications, and general well-being and quality of life. They may also be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketogenic diet | Experimental | Other: Ketogenic diet, food delivery and educationThe diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be ~ 5% carbohydrate, 20% protein, 70% fat. Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet. |
| standard diet | Active comparator | Other: Standard diet, food delivery and educationThe diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be ~50% carbohydrate (<10% added sugars), 20% protein, 30% fat. Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5 to 12 years.
- Within 3 month of diabetes diagnosis.
- Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis.
- Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker [glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin [prior to first insulin dose]; age under 10 years, BMI <95th percentile.
- Family committed and able to participate in study education and implement dietary intervention.
Key exclusion criteria (4 listed)
- Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic).
- Eating disorders as assessed by Chede-Q8.
- Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables.
- Major psychiatric illness.
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 |
|---|---|---|
| Ketogenic diet, food delivery and educationMeals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively. | Other | ketogenic diet |
| Standard diet, food delivery and educationMeals and groceries will be delivered and participants will receive education on nutrition, meal preparation, and diabetes care strategies. Participants will consume study-prescribed foods exclusively. | Other | standard diet |
Primary outcome
Decline in Beta-cell Function
Time frame: Change over 1, 5, and 9 months, corrected for baseline
Change in C-peptide 2-h area under the curve after a mixed-meal tolerance test (ΔCP).
28 secondary outcomes
Time in Range (TIR) 70-180 mg/dl
Time frame: Over 9 months and optional at 24 months
Duration of Clinical Diabetes Remission
Time frame: 1, 5, 9, and optional at 24 months
Time in low Range (TIR) <70 mg/dl
Time frame: Over 9 months and optional at 24 months
Time in very low Range (TIR) <55 mg/dl
Time frame: Over 9 months and optional at 24 months
Time in high Range (TIR) >180 mg/dl
Time frame: Over 9 months and optional at 24 months
Time in very high Range (TIR) >250 mg/dl
Time frame: Over 9 months and optional at 24 months
Average Blood Glucose
Time frame: Over 9 months and optional at 24 months
Coefficient of Glycemic Variation (CV)
Time frame: Over 9 months and optional at 24 months
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Over 9 months and optional at 24 months
Total Daily Insulin Dose
Time frame: Over 9 months and optional at 24 months
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
Time frame: 1, 5, 9, and optional at 24 months
BMI
Time frame: 1, 5, 9, and optional at 24 months
Lipid panel
Time frame: 1, 5, 9, and optional at 24 months
HDL to Triglyceride Ratio
Time frame: 1, 5, 9, and optional at 24 months
Lipoprotein Subfractions
Time frame: 1, 5, 9, and optional at 24 months
Inflammasome, targeted
Time frame: 1, 5, 9, and optional at 24 months
Microbiome, targeted and untargeted
Time frame: 1, 5, 9, and optional at 24 months
Metabolome, targeted and untargeted
Time frame: 1, 5, 9, and optional at 24 months
Problem Areas in Diabetes (PAID-Ped) - child
Time frame: 1, 5, 9, and optional at 24 months
Problem Areas in Diabetes (PAID-PR) - parent
Time frame: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) General Module - parent
Time frame: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) General Module - child
Time frame: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) Diabetes Module - parent
Time frame: 1, 5, 9, and optional at 24 months
Pediatric Quality of Life (PEDSQL) Diabetes Module - child
Time frame: 1, 5, 9, and optional at 24 months
Child Eating Disorder Examination Questionnaire (ChEDE-Q8)
Time frame: 1, 5, 9, and optional at 24 months
Perceptions on Diet Management of Diabetes
Time frame: 1, 5, 9, and optional at 24 months
Qualitative patient perspectives, interview - parent
Time frame: optional at 9 months
Qualitative patient perspectives, interview - child
Time frame: optional at 9 months
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 24 Apr 2025.
- Background: PubMed 33393511Lennerz BS, Koutnik AP, Azova S, Wolfsdorf JI, Ludwig DS. Carbohydrate restriction for diabetes: rediscovering centuries-old wisdom. J Clin Invest. 2021 Jan 4;131(1):e142246. doi: 10.1172/JCI142246.
- Background: PubMed 29735574Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.
- Individual participant dataSharing planned: Yes. Upon publication, de-identified raw data for each original article will be uploaded to the appropriate an NIH maintained repository.
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
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.
Belinda Lennerz principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet, food delivery and education and Standard diet, food delivery and education in people with Diabetes Mellitus, Type 1, run by Boston Children's Hospital at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 United States. 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 Belinda Lennerz, MD PhD (857-218-3896, belinda.lennerz@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in Beta-cell Function (time frame: Change over 1, 5, and 9 months, corrected for baseline). 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 NCT05899166, which also lists 2 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 24 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.