Continuous Glucose Monitoring and Insulin for Ketosis-Prone Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Priyathama Vellanki, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Emory University

Disqualifiers: Heart failure, Renal insufficiency, Liver insufficiency, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{10 11 12 13 14}

Research Team

Priyathama Vellanki, MD, MS

Principal Investigator

Emory University

Eligibility Criteria

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• Insulin (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.

Participant Groups

Group I: Continuous Glucose Monitoring with Adjusted Insulin Doses Experimental Treatment 2 Interventions

Patients with ketosis-prone diabetes will wear a continuous glucose monitor (CGM) from the time of hospital discharge until insulin discontinuation. Insulin doses will be adjusted based on CGM glucose readings.

Insulin is already approved in Canada for the following indications:

Approved in Canada as Insulin for:

• Diabetes mellitus

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A comparison of insulin lispro and regular human insulin (Humulin R) in 3634 patients with type 1 and type 2 diabetes showed no significant differences in treatment-emergent adverse events, indicating similar safety profiles for both insulins.

Both insulin therapies did not differ in their effects on the progression of chronic diabetes complications, such as retinopathy, neuropathy, cardiovascular disease, or kidney disease, suggesting that insulin lispro is as safe as Humulin R.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of insulin lispro: pooled data from clinical trials. Glazer, NB., Zalani, S., Anderson, JH., et al.[2019]

In a 32-week study involving 686 patients with Type 2 diabetes, insulin detemir (IDet) therapy was found to be safe, with no serious adverse drug reactions reported and a significant reduction in total hypoglycemic events from 435 to 204.

Patients experienced improved glycemic control, as indicated by a decrease in glycated hemoglobin A1c from 9.9% to 7.7% and fasting plasma glucose from 11.9 mmol/L to 7.4 mmol/L, alongside a slight reduction in body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. El Shiekh, AR., Farrag, HA., Ashour, T., et al.[2020]

Insulin remains the primary treatment for type 1 diabetes, but recent advancements in insulin analogues have significantly improved glycemic control and allowed for more physiological basal/bolus insulin regimens.

New basal insulin analogues, such as degludec, pegylated lispro, and glargine U300, have shown improvements in duration of action and reduced risk of hypoglycemia, addressing key challenges in intensive diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New insulin types in type 1 diabetes mellitus]. Mesa, J.[2015]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

[Insulin detemir (Levemir)]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of continuous subcutaneous insulin infusion with lispro on hepatic responsiveness to glucagon in type 1 diabetes. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Optimizing the replacement of basal insulin in type 1 diabetes mellitus: no longer an elusive goal in the post-NPH era. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Fast-Acting Insulin Aspart Use with the MiniMedTM 670G System. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Differences in bioactivity between human insulin and insulin analogues approved for therapeutic use- compilation of reports from the past 20 years. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety of insulin lispro: pooled data from clinical trials. [2019]

9. India pubmed.ncbi.nlm.nih.gov

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 States pubmed.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]

11. France pubmed.ncbi.nlm.nih.gov

[Insulin substitution: new insulins, new modes of delivery]. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

[New insulin types in type 1 diabetes mellitus]. [2015]

13. France pubmed.ncbi.nlm.nih.gov

[The insulin analog, Humalog, in discontinuous: from pharmacology to clinical use]. [2011]

14. Poland pubmed.ncbi.nlm.nih.gov

[New developments in the treatment and monitoring of type 1 diabetes mellitus]. [2017]