Type 1 Diabetes
Conditions
Brief summary
Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.
Detailed description
The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet. During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.
Interventions
OTHERLow carbohydrate diet
25-35% of carbohydrates from total energy intake
Sponsors
ICTS BJH
Center for Diabetes Translation Research
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
20 participants will be randomized to the intervention group (low carbohydrate diet) and 20 participants will be randomized to the control group
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years, * No carbohydrate restrictions at the time of recruitment. * No medications that could affect appetite * Regular attendance at the clinic (3-4 times per year), * Glycated hemoglobin (HbA1c) \<10%.
Exclusion criteria
* Impaired renal or liver function, * Chronic seizures or global developmental delay, * Diagnosed with ADHD and/or on ADHD medications * Use of drugs other than insulin affecting glucose metabolism * Severe eczema * Celiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypoglycemic events | 6 month study period | Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values \<70 mg/dL but ≥ 54 mg/dL and those \<54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values \<70 mg/dL but ≥ 54 mg/dL and \<54 mg/dL). |
| Episodes of diabetes related visits to the hospital, DKA | 6 month study period | Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits. |
| Dyslipidemia | 6 month study period | Investigators will evaluate the changes in LDL levels among the study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 6 month duration of the study | Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months. |
| Glucose variability | 6 month study period | Using CGM data investigators will evaluate glucose variability using standard deviation (SD) of all glucose values. Secondary endpoints will include time of the day spent in range (values between 70-140 mg/dl and between 70 and 180mg/dl), in hypoglycemia (values \<70 mgl/dl but ≥ 54 mg/dl and \<54 mg/dl) and in hyperglycemia (values \>180mg/dl and \>250 mg/dl). |
Countries
United States
Outcome results
None listed