12 Participants Needed

Continuous Glucose Monitoring and Insulin for Ketosis-Prone Diabetes

Recruiting at 1 trial location
PV
Overseen ByPriyathama Vellanki, MD, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is insulin safe for use in humans?

Research shows that various types of insulin, including insulin lispro and insulin detemir, have safety profiles comparable to regular human insulin. Studies have not found significant differences in adverse events or complications, indicating that these insulins are generally safe for use in humans.12345

How does the drug insulin differ from other treatments for ketosis-prone diabetes?

Insulin therapy for ketosis-prone diabetes is unique because it uses continuous glucose monitoring and a combination of fast-acting and long-acting insulin analogues to closely mimic natural insulin secretion, improving blood sugar control and reducing the risk of hypoglycemia (low blood sugar) compared to traditional insulin treatments.678910

What data supports the effectiveness of the drug Insulin, including Humulin R, Novolin R, and others, for treating ketosis-prone diabetes?

Research shows that insulin detemir (Levemir) is effective in maintaining blood sugar control with less risk of low blood sugar at night and less weight gain compared to other insulins. Additionally, insulin lispro (Humalog) and regular human insulin (Humulin R) have been studied for their effects on liver glucose production in type 1 diabetes, which is relevant for managing blood sugar levels.111121314

Who Is on the Research Team?

PV

Priyathama Vellanki, MD, MS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with ketosis-prone diabetes (KPDM), a condition where the body produces high levels of blood acids called ketones. Participants should be experiencing this for the first time or have a history of similar episodes but not on long-term insulin therapy.

Inclusion Criteria

Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose > 250 mg/dl, a venous pH < 7.30, a serum bicarbonate < 18 mmol/l, and serum ketones (beta-hydroxy butyrate) > 1.5 mmol/L.
Be of African American ancestry
My BMI is 28 or higher.
See 1 more

Exclusion Criteria

I was diagnosed with diabetes more than 90 days before my DKA episode.
Pregnant
I have an untreated hormone disorder like high cortisol, acromegaly, or overactive thyroid.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care insulin therapy and continuous glucose monitoring from hospital discharge until insulin discontinuation

Up to 3 months
Continuous monitoring with regular adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on remission duration

6 to 120 months

What Are the Treatments Tested in This Trial?

Interventions

  • Insulin
Trial Overview The study is monitoring day-to-day blood sugar levels using Continuous Glucose Monitoring systems and treating participants with insulin to understand how KPDM goes into remission and to develop a mathematical model describing this process.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Continuous Glucose Monitoring with Adjusted Insulin DosesExperimental Treatment2 Interventions

Insulin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Insulin for:
🇺🇸
Approved in United States as Insulin for:
🇨🇦
Approved in Canada as Insulin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Published Research Related to This Trial

Insulin detemir (Levemir) offers a long-acting and consistent insulin option for patients with type 1 or type 2 diabetes, providing a predictable effect with less variability in blood sugar control compared to NPH insulin.
It is at least as effective as NPH in managing overall blood sugar levels while reducing the risk of nocturnal hypoglycemia and causing less weight gain, making it a favorable choice for basal insulin therapy.
[Insulin detemir (Levemir)].Scheen, AJ., Radermecker, RP., Philips, JC., et al.[2015]
In a study involving 10 type 1 diabetes patients, insulin lispro (Humalog) was found to enhance the liver's response to glucagon, leading to a greater increase in hepatic glucose production compared to regular human insulin (Humulin R).
This increased sensitivity to glucagon with insulin lispro may help reduce the risk of severe hypoglycemia in type 1 diabetes patients undergoing intensive insulin therapy.
Effect of continuous subcutaneous insulin infusion with lispro on hepatic responsiveness to glucagon in type 1 diabetes.Launay, B., Zinman, B., Tildesley, HD., et al.[2022]
In a study of 221 adults with type 1 diabetes, switching to ultra-long-acting insulin (degludec U100 and glargine U300) did not significantly change the incidence of diabetic ketoacidosis (DKA) episodes, indicating that this new insulin type may not reduce DKA risk.
Despite higher total daily insulin doses after switching to ultra-long-acting insulin, there was no significant change in glycated hemoglobin A1C (HbA1c) levels, suggesting that insulin type and dosage alone may not be sufficient to control diabetes effectively.
Effects of Ultra-Long-Acting Insulin Compared to Long-Acting Insulin on Diabetic Ketoacidosis Incidence in Type 1 Diabetes Mellitus Patients.Alsofiani, WA., Alessa, BH., Alsabaan, F., et al.[2022]

Citations

[Insulin detemir (Levemir)]. [2015]
Effect of continuous subcutaneous insulin infusion with lispro on hepatic responsiveness to glucagon in type 1 diabetes. [2022]
Effects of Ultra-Long-Acting Insulin Compared to Long-Acting Insulin on Diabetic Ketoacidosis Incidence in Type 1 Diabetes Mellitus Patients. [2022]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes]. [2020]
Optimizing the replacement of basal insulin in type 1 diabetes mellitus: no longer an elusive goal in the post-NPH era. [2013]
Fast-Acting Insulin Aspart Use with the MiniMedTM 670G System. [2022]
Differences in bioactivity between human insulin and insulin analogues approved for therapeutic use- compilation of reports from the past 20 years. [2021]
Safety of insulin lispro: pooled data from clinical trials. [2019]
Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Insulin infusion therapy in critical care patients: regular insulin vs short-acting insulin. A prospective, crossover, randomized, multicenter blind study. [2018]
[Insulin substitution: new insulins, new modes of delivery]. [2019]
[New insulin types in type 1 diabetes mellitus]. [2015]
[The insulin analog, Humalog, in discontinuous: from pharmacology to clinical use]. [2011]
[New developments in the treatment and monitoring of type 1 diabetes mellitus]. [2017]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security