Type1diabetesNCT03710928
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
A study testing very low carbohydrate diet and standard carbohydrate diet in people with Type1diabetes, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- very low carbohydrate diet and standard carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females with T1D for at least 1 year
- Age 18 to 40 years
- Tanner stage ≥ IV
- BMI 18.5-35 kg/m2
- Stable glycemic control (HbA1c 6.5-9%)
- Use of a continuous glucose monitor (CGM)
- Use of an insulin pump
- Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
Who cannot join
- Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
- Following a weight-loss or otherwise restrictive diet
- Vigorous exercise >2 hours on >3 days a week
- History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
- Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
Show all 14Show fewer
- Significant psychiatric illness
- Smoking, use of recreational drugs, or excessive alcohol consumption
- Pregnancy or breastfeeding
- Anemia
- For participants who undergo MRI:
- Standard MRI exclusion criteria
- Irregular menses
- Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Azova contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Belinda S Lennerz, MD PhD, 8572183896, belinda.lennerz@childrens.harvard.edu
About this study
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.
To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
- Conditions
- Type1diabetes
- Being tested
- very low carbohydrate diet, standard carbohydrate diet
- Keywords
- very low carbohydrate diet, nutrition, ketogenic diet, ketosis, nutritional ketosis, metabolism, metabolic health
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low carbohydrate dietOther
All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement as needed with each meal to support digestive health, and a daily multi-vitamin, magnesium and omega-three supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
The diet composition will be as follows: 5% carbohydrate, 70% fat, 20% protein.
standard carbohydrate dietOther
All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein.
| Study group | Role | What they receive |
|---|---|---|
| very low carbohydrate diet | Experimental | Dietary Intervention, food delivery Receives: Other: very low carbohydrate diet |
| standard diet | Active comparator | Dietary Intervention, food delivery Receives: Other: standard carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C change
HbA1C change from baseline at 12 weeks will be compared between the 2 interventions
Measured: 12 weeks - baseline
Secondary outcomes (20)
total daily insulin dose
average daily insulin dose over 1 week will be calculated
Measured: week 0 and 12
percent time spent in the glycemic target range of 70-140 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
percent time spent below the glycemic target of 70 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
percent time in hypoglycemia below 54 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
percent time spent above the glycemic target of 140 mg/dl
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
percent time spent in hyperglycemia
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
blood glucose average
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
blood glucose standard deviation
will be calculated from 1-week continuous glucose monitoring data
Measured: week 0 and 12
Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level
will be calculated by dividing blood glucose standard deviation by blood glucose average
Measured: week 0 and 12
Mean Amplitude of Glycemic Excursions (MAGE), a measure for postprandial glycemic variability
will be calculated by dividing blood glucose standard deviation by blood glucose average
Measured: week 0 and 12
fasting total cholesterol
from venous blood
Measured: week 0 and 12
fasting high density lipoprotein cholesterol
from venous blood
Measured: week 0 and 12
fasting low density lipoprotein cholesterol
from venous blood
Measured: week 0 and 12
fasting triglycerides
from venous blood
Measured: week 0 and 12
fasting beta hydroxybutyrate
from venous blood and/or point-of-care testing
Measured: weeks 0, 1, 2, 4, 6, 9, 12
fasting high-sensitivity c-reactive protein
from venous blood
Measured: week 0 and 12
Self-reported quality of life assessed per self-report by The Problem Areas in Diabetes Scale (PAID)
The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100.
Measured: week 0, 6, and 12
Becks Depression Inventory II (BDI II) less suicidality
BDI-II less suicidality is a 20-item self-report inventory that measures assesses for presence and severity of depression depressive symptoms. Each item is scored between 0-3. Item scores are added up to a total score (max. 60) and reported.
Measured: week 0, 6, and 12
Yale Food Addiction Scale 2.0 (YFAS 2.0)
Assesses indicators of addictive-like eating.The YFAS includes two scoring options: 1) a "symptom count" that reflects the number of addiction-like criteria endorsed and 2) a dichotomous "diagnosis" that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met. The diagnosis score will be calculated at baseline and used as an effect modifier. Symptom counts will be reported separately as a longitudinal measure.
Measured: week 0, 6, and 12
Highly Processed Food Withdrawal Scale (ProWS)
Assesses withdrawal-type symptoms that may occur when individuals cut down on rewarding foods.
Measured: Baseline, daily on days 1-7, then weekly; primary focus on change from baseline to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start3 Jan 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial, 12-week feeding study
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belinda Lennerz, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710928
- Sponsor's protocol ID
- IRB-P00030039
- Status last verified
- Dec 2024
- First submitted
- 16 Oct 2018
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lennerz 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
- ClinicalTrials.gov ID
- NCT03710928
- Acronym / sponsor ID
- IRB-P00030039
- Conditions
- Type1diabetes
- Keywords
- very low carbohydrate diet, nutrition, ketogenic diet, ketosis, nutritional ketosis, metabolism, metabolic health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 18 Oct 2018 (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.
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.
To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial, 12-week feeding study
| Arm | Type | Receives |
|---|---|---|
| very low carbohydrate diet | Experimental | Other: very low carbohydrate dietDietary Intervention, food delivery |
| standard diet | Active comparator | Other: standard carbohydrate dietDietary Intervention, food delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females with T1D for at least 1 year
- Age 18 to 40 years
- Tanner stage ≥ IV
- BMI 18.5-35 kg/m2
- Stable glycemic control (HbA1c 6.5-9%)
Key exclusion criteria (14 listed)
- Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
- Following a weight-loss or otherwise restrictive diet
- Vigorous exercise >2 hours on >3 days a week
- History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
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 |
|---|---|---|
| very low carbohydrate dietAll meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement as needed with each meal to support digestive health, and a daily multi-vitamin, magnesium and omega-three supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 5% carbohydrate, 70% fat, 20% protein. | Other | very low carbohydrate diet |
| standard carbohydrate dietAll meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein. | Other | standard diet |
Primary outcome
Hemoglobin A1C change
Time frame: 12 weeks - baseline
HbA1C change from baseline at 12 weeks will be compared between the 2 interventions
20 secondary outcomes
total daily insulin dose
Time frame: week 0 and 12
percent time spent in the glycemic target range of 70-140 mg/dl
Time frame: week 0 and 12
percent time spent below the glycemic target of 70 mg/dl
Time frame: week 0 and 12
percent time in hypoglycemia below 54 mg/dl
Time frame: week 0 and 12
percent time spent above the glycemic target of 140 mg/dl
Time frame: week 0 and 12
percent time spent in hyperglycemia
Time frame: week 0 and 12
blood glucose average
Time frame: week 0 and 12
blood glucose standard deviation
Time frame: week 0 and 12
Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level
Time frame: week 0 and 12
Mean Amplitude of Glycemic Excursions (MAGE), a measure for postprandial glycemic variability
Time frame: week 0 and 12
fasting total cholesterol
Time frame: week 0 and 12
fasting high density lipoprotein cholesterol
Time frame: week 0 and 12
fasting low density lipoprotein cholesterol
Time frame: week 0 and 12
fasting triglycerides
Time frame: week 0 and 12
fasting beta hydroxybutyrate
Time frame: weeks 0, 1, 2, 4, 6, 9, 12
fasting high-sensitivity c-reactive protein
Time frame: week 0 and 12
Self-reported quality of life assessed per self-report by The Problem Areas in Diabetes Scale (PAID)
Time frame: week 0, 6, and 12
Becks Depression Inventory II (BDI II) less suicidality
Time frame: week 0, 6, and 12
Yale Food Addiction Scale 2.0 (YFAS 2.0)
Time frame: week 0, 6, and 12
Highly Processed Food Withdrawal Scale (ProWS)
Time frame: Baseline, daily on days 1-7, then weekly; primary focus on change from baseline to day 7
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 18 Dec 2024.
- 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: 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.
Azova contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low carbohydrate diet and standard carbohydrate diet in people with Type1diabetes, 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 8 inclusion and 14 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 18 Dec 2024. 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 (8572183896, 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?
Hemoglobin A1C change (time frame: 12 weeks - 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 NCT03710928, which also lists 1 linked publication.
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 18 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.