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Tests treatment safety and results for Diabetes Mellitus, Type 1
Official title Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
ClinicalTrials.gov ID: NCT06503809
What this study is testing
- What it's testing
- Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age ≥18 and ≤65 years
- T1D diagnosed \>1 year prior to screening
- HbA1c 7.0%-9.0%
- Stable insulin delivery method for the past 30 days
- Ability to read all device instructions and insulin pump settings
You likely can't join if
- Body mass index \ 34.9 kg/m2
- Severe gastroparesis or history of bariatric surgery
- Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening
- Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
- Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)
- Structured exercise \>210 minutes per week
See the full eligibility criteria
- Age ≥18 and ≤65 years
- T1D diagnosed \>1 year prior to screening
- HbA1c 7.0%-9.0%
- Stable insulin delivery method for the past 30 days
- Ability to read all device instructions and insulin pump settings
- eGFR ≥60 mL/min/1.73 m2
- Use of an insulin pump or insulin delivery by multiple daily injections
- Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products
- Use of cellular phone with data capability for wireless connectivity to the CGM system.
- Body mass index \ 34.9 kg/m2
- Severe gastroparesis or history of bariatric surgery
- Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening
- Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
- Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)
- Structured exercise \>210 minutes per week
- Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period
- Unstable weight (\>4% change in the last 2 months)
- Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)
- Anemia (Hgb \<10 g/dL)
- Major psychiatric illness
- Active tobacco use (\>8 cigarettes/day) or illegal drug use
- Regular alcohol consumption (\>10 standard drinks per week)
- Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study
- Familial hypercholesterolemia
- Active eating disorder
- Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food...
- Already consuming a low-carbohydrate (\<130 g/day) diet
- Persons who are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.