Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet

ConditionType1diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females with T1D for at least 1 year

Age 18 to 40 years

Tanner stage ≥ IV

BMI 18.5-35 kg/m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • very low carbohydrate diet

    Other intervention

    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 diet

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: very low carbohydrate dietExperimental treatment 1 intervention
Group B: standard dietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin A1C change

HbA1C change from baseline at 12 weeks will be compared between the 2 interventions

Time frame
12 weeks - baseline

Secondary outcomes

1

total daily insulin dose

average daily insulin dose over 1 week will be calculated

Time frame
week 0 and 12
2

percent time spent in the glycemic target range of 70-140 mg/dl

will be calculated from 1-week continuous glucose monitoring data

Time frame
week 0 and 12
3

percent time spent below the glycemic target of 70 mg/dl

will be calculated from 1-week continuous glucose monitoring data

Time frame
week 0 and 12
4

percent time in hypoglycemia below 54 mg/dl

will be calculated from 1-week continuous glucose monitoring data

Time frame
week 0 and 12

Other outcomes

Sponsors and contacts

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