Luna System for Diabetes

(AID4MDI Trial)

Recruiting at 2 trial locations

Overseen By Daniela Fuerte, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luna Diabetes

Must be taking: Insulin lispro, Insulin aspart

Must not be taking: Hydroxyurea, Corticosteroids

Disqualifiers: Pregnancy, Renal failure, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications, but you must have a stable dose of any non-insulin glucose-lowering drugs or weight loss medications for at least 30 days before starting. You cannot use certain medications like hydroxyurea or corticosteroids that affect blood sugar levels during the study.

What data supports the effectiveness of the Luna System for Diabetes treatment?

Research on insulin pump therapy, like the OmniPod System, shows that using a patch pump can improve blood sugar control and reduce episodes of low blood sugar in people with diabetes. This suggests that the Luna System, as a patch pump, might offer similar benefits. ^{1 2 3 4 5}

Is the Luna System for Diabetes safe for humans?

Insulin pumps, like the Luna System, have been shown to be generally safe in both children and adults with type 1 diabetes. They can reduce severe low blood sugar events, although some users may experience local skin issues or infections. Overall, the safety profile is positive, with low rates of discontinuation due to adverse effects. ^{3 5 6 7 8}

How does the Luna System for Diabetes differ from other diabetes treatments?

The Luna System for Diabetes is unique because it is an episodic overnight patch pump, which means it is a wearable device that delivers insulin during the night, potentially improving blood sugar control while you sleep. This differs from traditional insulin pumps that provide continuous insulin delivery throughout the day and night. ^{3 4 7 9 10}

What is the purpose of this trial?

The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The study device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. The study device does not replace long-acting, correction, or mealtime insulin. The study will involve applying the study device before bed for a period of 13 weeks. The overall study length is approximately 17 weeks. The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake.

Research Team

Jeremy Pettus, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adults over 18 with Type 1 Diabetes who've been on a stable insulin regimen for at least a month. They must use rapid-acting insulin, have used CGM systems for three months or more, and experience high blood sugar at night frequently. Participants need to be iPhone users and cannot start new glucose-lowering or weight loss drugs within the last month.

Inclusion Criteria

I have been using a CGM device for over 3 months with consistent use in the last month.

I have been on a stable dose of my diabetes medication for at least 30 days.

I have been diagnosed with Type 1 Diabetes for over 6 months and on a stable insulin plan for over 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply the study device before bed for a period of 13 weeks to evaluate its effect on blood sugar levels during sleep

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Episodic overnight patch pump

Trial Overview The study tests an overnight patch pump that works with continuous glucose monitors to manage blood sugar levels during sleep. It's not meant to replace other insulins but aims to stabilize nighttime blood sugars over a 13-week period of use before bedtime.

Participant Groups

Group I: Overnight wear of study device Experimental Treatment 1 Intervention

Subjects will wear the study device during sleep in addition to their usual basal/bolus therapy.

Who Is Running the Clinical Trial?

Luna Diabetes

Lead Sponsor

Trials

1

Recruited

120+

Findings from Research

Insulin pump therapy (CSII) significantly improves glycemic control in children with diabetes, leading to reductions in hypoglycemia, diabetic ketoacidosis (DKA), and mean HbA1c levels, while also enhancing quality of life and patient responsibility.

Using the pump at night for young children (ages 7-10) allows for better nocturnal glycemia management without the risks associated with daytime use, highlighting the importance of tailored education for families in effectively managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump therapy in type 1 pediatric patients: now and into the year 2000. Kaufman, FR., Halvorson, M., Miller, D., et al.[2019]

In a study involving 110 patients with type 1 diabetes, the Medtronic 640G system's predictive low-glucose suspend (PLGS) feature was found to effectively balance the risks of hypoglycemia and hyperglycemia, with optimal PLGS duration between 157.5 and 174.4 minutes per day.

The analysis revealed that a lower basal insulin percentage and longer PLGS duration were associated with reduced hyperglycemia, while specific PLGS settings could be adjusted through total daily insulin dose to enhance overall glucose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. Joubert, M., Briant, AR., Kessler, L., et al.[2022]

The OmniPod® Insulin Management System is the first commercially available patch pump, offering a fully integrated and wireless insulin delivery solution that includes a built-in blood glucose meter.

This review highlights the OmniPod's advantages over traditional insulin pumps, including its potential use in advanced diabetes management projects like the Juvenile Diabetes Research Foundation's Artificial Pancreas Project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OmniPod Insulin Management System: the latest innovation in insulin pump therapy. Zisser, HC.[2021]

In a study involving four type 1 diabetics with long-standing diabetes, the use of a portable open-loop insulin infusion system for four months led to improved metabolic control, evidenced by lower blood glucose levels and reduced urinary glucose excretion.

All patients reported feeling well during the treatment, and while there were some technical complications, the overall safety profile was favorable, indicating that this method of insulin delivery can be effective for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improvement in the treatment of diabetes by means of a portable insulin-infusion apparatus. Preliminary results in 4 unstable juvenile diabetics]. Porr, O., Morell, B., Walter, H., et al.[2011]

Over 40% of insulin pump users experience adverse events each year, with hyperglycemia and ketosis being the most common outcomes, particularly linked to infusion set failures.

The review emphasizes the need for continuous education and support for patients using insulin pumps to enhance their experience and potentially reduce the frequency and severity of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review: insulin pump-associated adverse events in adults and children. Ross, PL., Milburn, J., Reith, DM., et al.[2022]

The mylife™ OmniPod® patch pump showed low accuracy in delivering insulin, especially at lower doses, with only 18.6% to 96.0% of bolus doses meeting the ±5% accuracy threshold, compared to the MiniMed® 640G which had higher accuracy rates, particularly at larger bolus volumes.

Both insulin pumps demonstrated better accuracy at higher bolus volumes and later delivery times, but overall, clinicians should be cautious about the variability in insulin delivery, particularly for patients requiring low doses, as this could impact treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Dose Accuracy of Durable and Patch Insulin Pumps Under Laboratory Conditions. Laubner, K., Singler, E., Straetener, J., et al.[2020]

Insulin pump therapy for children and adolescents with type 1 diabetes has shown a significant reduction in severe hypoglycemia, particularly during the night, while maintaining a low rate of ketoacidosis, indicating its safety and efficacy.

The treatment allows for precise insulin delivery tailored to individual needs, which is especially beneficial for very young children, and has been associated with improved quality of life, contributing to its increasing adoption in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump treatment in children and adolescents with type 1 diabetes. Hofer, S., Meraner, D., Koehle, J.[2022]

A systematic review and meta-analysis of four studies involving 272 patients with type 1 diabetes showed that predictive low glucose suspend (PLGS) systems significantly reduce the risk of nocturnal hypoglycemia, with a decrease from 27.8% to 19.6% in hypoglycemic episodes during overnight periods.

The analysis indicated that PLGS systems are associated with an 8.8% lower risk of experiencing hypoglycemia compared to non-PLGS periods, highlighting their effectiveness in managing blood sugar levels during the night.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia. Chen, E., King, F., Kohn, MA., et al.[2020]

The Medtronic 670G closed-loop insulin system improved glycemic control in a pregnant woman with type 1 diabetes, with 83-94% of her time spent in the target glucose range (70-180 mg/dL).

The use of this system also reduced the patient's stress, anxiety, and fear of hypoglycemia, and there were no complications for the mother or baby, indicating its safety during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Closed-Loop System Improved the Control of a Pregnant Patient with Type 1 Diabetes Mellitus. Guzmán Gómez, GE., Viggiano, JA., Silva-De Las Salas, A., et al.[2022]

The study involved 17 adolescents with type 1 diabetes and demonstrated that using a closed-loop artificial pancreas system can help maintain near-normal glucose levels, especially during the night.

Adding small manual premeal 'priming' boluses of insulin significantly reduced post-meal glucose spikes, improving overall glucose control compared to full closed-loop control without priming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Weinzimer, SA., Steil, GM., Swan, KL., et al.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Insulin pump therapy in type 1 pediatric patients: now and into the year 2000. [2019]

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

Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. [2022]

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

The OmniPod Insulin Management System: the latest innovation in insulin pump therapy. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Improvement in the treatment of diabetes by means of a portable insulin-infusion apparatus. Preliminary results in 4 unstable juvenile diabetics]. [2011]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical review: insulin pump-associated adverse events in adults and children. [2022]

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

Comparative Dose Accuracy of Durable and Patch Insulin Pumps Under Laboratory Conditions. [2020]

7. Italy pubmed.ncbi.nlm.nih.gov

Insulin pump treatment in children and adolescents with type 1 diabetes. [2022]

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

A Review of Predictive Low Glucose Suspend and Its Effectiveness in Preventing Nocturnal Hypoglycemia. [2020]

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

The Closed-Loop System Improved the Control of a Pregnant Patient with Type 1 Diabetes Mellitus. [2022]

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

Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. [2011]