An interventional study of Ketogenic diet, food delivery and education and Standard diet, food delivery and education in Diabetes Mellitus, Type 1, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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:
Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months.
Comparison will be made between a ketogenic vs standard diet.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 52 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Ketogenic diet, food delivery and education
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.
Other: Standard diet, food delivery and education
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.
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.
Decline in Beta-cell Function
Change in C-peptide 2-h area under the curve after a mixed-meal tolerance test (ΔCP).
Time frame: Change over 1, 5, and 9 months, corrected for baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Over 9 months and optional at 24 months
Average Blood Glucose
From CGM - will be computed throughout study participation in 2-week increments.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1, 5, 9, and optional at 24 months
BMI
Weight divided by height squared.
Time frame: 1, 5, 9, and optional at 24 months
Lipid panel
Fasting blood - total, LDL and HDL cholesterol, and triglycerides.
Time frame: 1, 5, 9, and optional at 24 months
HDL to Triglyceride Ratio
Fasting blood
Time frame: 1, 5, 9, and optional at 24 months
Lipoprotein Subfractions
Fasting blood
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: optional at 9 months
Time in tight Range (TIR) 70-140 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Time frame: Over 9 months and optional at 24 months
Time above tight Range (TIR) >140 mg/dl
From CGM - percent time spent in the specified glycemic target range will be computed throughout study participation in 2-week increments.
Time frame: Over 9 months and optional at 24 months
BOHB (beta-hydroxybutyrate), fasting blood concentration
Obtained at daily increasing to weekly intervals as effect modifier of beta-cell function.
Time frame: Over 9 months and optional at 24 months
Growth
Safety Measure - Height standard deviation score will be calculated from serial height measurements obtained during study visits using CDC age and sex specific references.
Time frame: 1, 5, 9, and optional at 24 months
Growth velocity
Safety Measure - Growth velocity will be calculated from serial height measurements obtained during study visits.
Time frame: 1, 5, 9, and optional at 24 months
Weigh-gain
Safety Measure - Weight SDS and gain will be calculated from serial weight measures obtained during study visits with calibrated scale.
Time frame: 1, 5, 9, and optional at 24 months
Confirmed Ketoacidosis
Safety Measure - Defined by elevated BOHB, blood pH \<7.3 and serum bicarbonate \<15. Rates will be computed as total number of events divided by total patient years of follow-up.
Time frame: Over 9 months and optional at 24 months
Severe Hypoglycemia
Safety Measure - Defined as blood glucose \< 55 mg/dl and requiring glucagon or resulting in seizure or coma. Rates will be computed as total number of events divided by total patient years of follow-up.
Time frame: Over 9 months and optional at 24 months
Diabetes Related Emergency Visits
Safety Measure - Rates will be computed as total number of events divided by total patient years of follow-up.
Time frame: Over 9 months and optional at 24 months
Diabetes Related Hospitalizations
Safety Measure - Rates will be computed as total number of events divided by total patient years of follow-up.
Time frame: Over 9 months and optional at 24 months
Study termination for disordered eating
Safety Measure - ChEDE-Q8 diagnostic score with clinical confirmation. Total number of events.
Time frame: Over 9 months
Study termination for growth deceleration
Safety Measure - Undesired weight loss or significant deceleration in longitudinal growth may warrant termination of study participation. Total number of events will be computed.
Time frame: Over 9 months
Study termination for dyslipidemia
Safety Measure - LDL \>200 mg/dl will trigger review of additional risk factors and may prompt diet modification to lower intake of saturated fats. If persistent, study participation may be terminated. Total number of events will be computed.
Time frame: Over 9 months
Plan to share: Yes — Upon publication, de-identified raw data for each original article will be uploaded to the appropriate an NIH maintained repository.
Supporting information: Study protocol, Sap
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