Hypoglycemia Prevention Program for Low Blood Sugar

Overseen By Scott J Pilla, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Insulin, Sulfonylureas, Meglitinides

Disqualifiers: Cognitive impairment, Hospice care, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to prevent low blood sugar (hypoglycemia) in people with diabetes who take medications like insulin. The program includes the Glucagon Emergency Kit (Glucagon for Injection) as part of the Hypoglycemia Prevention Program. Participants will visit their clinic twice to evaluate the program's effectiveness and potential improvements for future use. This trial suits adults with diabetes who take specific medications and receive care from a primary care provider at Johns Hopkins Green Spring Station. As an unphased trial, it allows participants to contribute to innovative diabetes care solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves patients taking medications that can cause low blood sugar, it seems likely that you will continue your current diabetes medications.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, since it involves patients taking medications that can cause low blood sugar, it seems likely that you will continue your current diabetes medications.

What prior data suggests that this hypoglycemia prevention program is safe?

Research has shown that glucagon, a common emergency treatment for low blood sugar, is generally safe and well-tolerated. Studies have demonstrated that glucagon effectively raises blood sugar levels in people with diabetes who experience severe hypoglycemia, a dangerously low blood sugar condition.

Glucagon has been used for many years and acts quickly in emergencies. Most people do not experience major side effects, but some might feel nauseous or vomit. It is important to note that glucagon might not work as well if taken with certain medications, such as indomethacin.

Overall, glucagon is considered safe due to its frequent use in treating low blood sugar episodes. It is regarded as a reliable option for managing these conditions without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hypoglycemia Prevention Program because it offers a new approach to managing low blood sugar by focusing on education and preventive strategies rather than traditional medication. Unlike standard options that often rely on glucose tablets or injections to treat acute hypoglycemia, this program involves patients, primary care physicians, and clinic staff working together. By equipping primary care physicians with a specialized toolkit and involving clinic staff, the program aims to prevent episodes before they happen, potentially improving the quality of life for patients with diabetes. This proactive and collaborative approach could lead to more sustainable and effective management of hypoglycemia.

What evidence suggests that the Hypoglycemia Prevention Program is effective for preventing low blood sugar?

Research has shown that glucagon effectively treats severe low blood sugar (hypoglycemia). Studies have found that glucagon can nearly halve the risk of hypoglycemia episodes, with a risk ratio of 0.54. It is often used as an emergency treatment to quickly raise blood sugar levels. New methods of administering glucagon are making it easier and more promising to manage low blood sugar. Although these advancements are encouraging, challenges remain in glucagon production and use, which researchers are actively addressing. Participants in this trial will join the Hypoglycemia Prevention Program, which includes various approaches to improve low blood sugar management. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott J Pilla, MD, MHS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with low blood sugar or diabetes who are currently on medications that can cause hypoglycemia. Details about specific inclusion and exclusion criteria are not provided, but typically participants need to meet certain health conditions.

Inclusion Criteria

I live at home, not in a nursing home or long-term care facility.

Diabetes mellitus by electronic health record review

Physician at the Johns Hopkins Internal Medicine Green Spring Station

Exclusion Criteria

Implantable pacemaker (for continuous glucose monitoring)

Receiving hospice or end of life care

Planning to leave area prior to end of study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Clinic Visit

Participants undergo a baseline clinic visit as part of usual care

1 day

1 visit (in-person)

Intervention Clinic Visit

Participants receive the hypoglycemia prevention program intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypoglycemia Prevention Program

Trial Overview The study tests a new program aimed at preventing low blood sugar in patients. It involves groups of primary care physicians, patients, and clinic staff working together. The goal is to see if the program works well in a real-world setting before planning a larger trial.

How Is the Trial Designed?

Group I: Primary Care Physician (PCP) Involvement Experimental Treatment 1 Intervention

PCPs will be given access to the Hypoglycemia Prevention toolkit

Group II: Patient Involvement Experimental Treatment 1 Intervention

Patients who participate in the study will undergo one Baseline Clinic Visit (baseline usual care), and one Intervention clinic visit.

Group III: Clinic Staff Involvement Experimental Treatment 1 Intervention

Hypoglycemia Prevention Program is already approved in United States for the following indications:

Approved in United States as Glucagon Emergency Kit for:

• Severe hypoglycemia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Naloxone is a safe and effective antidote for opioid overdose, with a long history of use by healthcare professionals, and expanding access to it for high-risk individuals and their families is a key public health initiative.

While naloxone is generally safe, its administration can lead to varying levels of adverse reactions, especially with higher doses or intravenous use, highlighting the importance of training for non-healthcare professionals in recognizing overdoses and administering naloxone correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Wermeling, DP.[2020]

In a study involving 16 participants, the glucagon autoinjector (GAI) demonstrated a significantly higher success rate (88%) in administering rescue injections compared to traditional glucagon emergency kits (31%), indicating its superior usability for severe hypoglycemia management.

In a larger validation study with 75 volunteers, an impressive 98.7% successfully used the GAI, showing that it can be safely and effectively operated by both trained and untrained users, supporting its potential as a reliable alternative to existing glucagon kits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation. Valentine, V., Newswanger, B., Prestrelski, S., et al.[2023]

The 'Danish Save Lives' program, which trained 552 participants including police officers, opioid users, and social workers, demonstrated that overdose education and naloxone distribution can effectively reduce opioid overdose deaths, with 37 participants intervening in 45 overdose events.

Participants who used opioids were significantly more likely to intervene in overdose situations, highlighting the importance of targeting opioid users in prevention programs for greater effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One opioid user saving another: the first study of an opioid overdose-reversal and naloxone distribution program addressing hard-to-reach drug scenes in Denmark. Thylstrup, B., Hesse, M., Jørgensen, M., et al.[2020]

A state-wide naloxone distribution program in West Virginia successfully distributed 8,250 rescue kits, highlighting the importance of collaborative partnerships and community demand for naloxone as key facilitators in reducing opioid overdose deaths.

Despite facing barriers such as organizational bureaucracy and stigma, the overall positive impact of the program suggests that effective implementation strategies can overcome these challenges, providing valuable insights for future large-scale naloxone distribution efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators, barriers and lessons learnt from the first state-wide naloxone distribution conducted in West Virginia. Rudisill, TM., Ashraf, AJ., Linn, HI., et al.[2022]

A pilot program was created to distribute naloxone kits, which are designed to reverse opioid overdoses, aiming to reduce overdose deaths.

The program also included education for patients about the risks associated with opioid use, highlighting the importance of awareness in preventing overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Overdose Education and Naloxone Distribution Program at a VA Hospital. Peckham, AM., Boggs, DL.[2023]

From 1996 to June 2014, organizations distributed naloxone kits to over 152,000 laypersons, leading to 26,463 reported overdose reversals, highlighting the effectiveness of community-based opioid overdose prevention programs.

The training and provision of naloxone to bystanders can significantly reduce opioid overdose deaths, addressing a critical public health issue as drug overdose deaths have more than doubled since 1999.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Overdose Prevention Programs Providing Naloxone to Laypersons - United States, 2014. Wheeler, E., Jones, TS., Gilbert, MK., et al.[2022]

A pharmacist-led outreach program significantly increased glucagon prescribing rates, with 56% of patients receiving a prescription after outreach compared to only 0.9% in the control group, highlighting the effectiveness of this intervention.

The outreach was particularly beneficial for Black patients, who had a higher prescribing rate (71.4%) compared to white patients (49.3%), suggesting that targeted interventions can help address disparities in medication access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacist outreach on glucagon prescribing. Whitfield, N., Gregory, P., Liu, B., et al.[2023]

Intranasal (IN) glucagon is a newly approved, safe, and effective treatment for hypoglycemia in patients aged 4 years and older, showing over 98% success in treating hypoglycemic events, comparable to intramuscular (IM) glucagon.

IN glucagon can be administered quickly (in less than a minute) without the need for reconstitution, making it a convenient needle-free option for those uncomfortable with injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies. Lowe, RN., Trujillo, JM.[2020]

The American Diabetes Association, in collaboration with other organizations, publishes success stories that showcase effective strategies for improving diabetes care.

One highlighted initiative focuses on ensuring that patients at risk for severe hypoglycemic events have a practical glucagon emergency plan, which is crucial for their safety and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Center of Excellence Hypoglycemia Emergency Preparedness Project. Cobb, EC., Watson, NA., Wardian, J., et al.[2020]

Tight glycemic control in diabetes is crucial for preventing vascular complications, but it increases the risk of hypoglycemia, making effective treatments like glucagon essential.

Glucagon is an underused emergency treatment for severe hypoglycemia, highlighting the need for better education for patients and caregivers to ensure they are prepared to use it in emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of severe diabetic hypoglycemia with glucagon: an underutilized therapeutic approach. Kedia, N.[2021]

New glucagon delivery methods, such as nasal sprays and autoinjection pens, have been approved and are easier to use than traditional glucagon kits, which require complicated preparation.

These novel glucagon forms are as effective as the older kits and may lead to better treatment of severe hypoglycemia in older adults, potentially improving health outcomes and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly Approved Novel Dosage Forms of Glucagon for Management of Severe Hypoglycemia. Borden, TJ., Baker, DE., Levien, TL., et al.[2021]

In a study of 300 insulin-treated diabetic patients, 77.7% reported experiencing hypoglycemia, and 24.3% had severe hypoglycemia, highlighting the prevalence of these episodes among this population.

Despite the high incidence of severe hypoglycemia, only 35.6% of patients used glucagon when needed, indicating a significant underuse of this life-saving treatment, which is linked to a lack of knowledge about glucagon therapy, particularly among those who have not attended diabetes education sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemia and Glucagon Utilization in Insulin-Treated Diabetic Patients. Vilovic, M., Kurir, TT., Novak, A., et al.[2021]

In a simulated user experience study with 39 participants, nasal glucagon (NG) administration was significantly more successful (89.5% vs 26.3%) and quicker (mean time of 23.9 seconds vs 207.3 seconds) compared to intramuscular glucagon (IMG) among caregivers.

Nasal glucagon was also found to be easy to use, with 80% of third parties and all caregivers expressing confidence in using it during real emergencies, indicating its potential as a preferred option for treating severe hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of Nasal Glucagon Device: Partially Randomized Caregiver and Third-Party User Experience Trial with Simulated Administration at a Japanese Site. Aranishi, T., Nagai, Y., Takita, Y., et al.[2020]

New glucagon formulations, such as nasal powder and liquid-stable glucagon, have improved ease of use and are designed to be more effective in emergency situations for treating severe hypoglycemia in diabetic patients.

These newer formulations address the historical challenges of glucagon administration, which was often underutilized due to the complexity of reconstitution and concerns about safety, thereby enhancing patient confidence in emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon: Its evolving role in the management of hypoglycemia. Isaacs, D., Clements, J., Turco, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12368384/

Low-Dose Glucagon to Prevent and Treat Exercise ... The meta-analysis showed significant reductions in hypoglycemia risk (risk ratio 0.54; 95% CI 0.35, 0.84) and TBR (−3.91 percentage points; 95% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3180523/

Treatment of severe diabetic hypoglycemia with glucagon Glucagon is an effective therapy for treating severe hypoglycemia. Available as an emergency kit, glucagon is an essential tool for rapid response, but remains ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/201849s013lbl.pdf

glucagon for injection - accessdata.fda.gov Clinical Impact: In patients taking indomethacin, Glucagon for Injection may lose its ability to raise blood glucose or may even produce hypoglycemia.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037851732400019X

Glucagon: Delivery advancements for hypoglycemia ... Advancements in glucagon delivery systems for managing hypoglycemia are unfolding with promise, albeit accompanied by formulation and implementation challenges.

5. mayoclinic.org mayoclinic.org/drugs-supplements/glucagon-injection-route/description/drg-20064089

Glucagon (injection route) - Side effects & dosage Glucagon injection is an emergency medicine used to treat severe hypoglycemia (low blood sugar) in diabetes patients treated with insulin.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10473428/

Evaluating Ease of Use and Patient Safety of Dasiglucagon ... Results from this analysis showed that dasiglucagon has a safety and tolerability like GlucaGen and a comparable plasma glucose recovery time, ...

7. glucagonemergencykit.com glucagonemergencykit.com/

Glucagon Emergency Kit: Home This injection is administered under the skin to quickly treat patients with diabetes who experience unexpected episodes of severe hypoglycemia.

8. diabetesjournals.org diabetesjournals.org/clinical/article/41/3/399/148561/Severe-Hypoglycemia-and-the-Use-of-Glucagon-Rescue

Severe Hypoglycemia and the Use of Glucagon Rescue Agents Insulin therapy carries an increased risk of hypoglycemia, a significant and potentially fatal complication of diabetes management (1–4). The ...