What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, which can cause side effects such as hypoglycemia, weight gain, and injection site reactions. Pancreatic Enzyme Replacement Therapy (CREON), used to manage pancreatic exocrine insufficiency, can improve glycemic control and reduce digestive symptoms. Side effects of CREON may include gastrointestinal issues such as abdominal pain, bloating, and diarrhea. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes, primarily focusing on insulin therapy to manage blood glucose levels. These include multiple daily injections of insulin and continuous subcutaneous insulin infusion. While Pancreatic Enzyme Replacement Therapy (CREON) is not specifically approved for Type 1 Diabetes, it is being studied for its potential to improve glycemic control and reduce symptoms of pancreatic exocrine insufficiency by supplementing digestive enzymes. This approach could benefit patients with Type 1 Diabetes who experience reduced pancreatic volume and related digestive issues.

What other types of research exist?

Promising novel alternatives to Pancreatic Enzyme Replacement Therapy (CREON) for Type 1 Diabetes patients include: 1) Hybrid Closed-Loop (HCL) insulin delivery systems, which automate insulin delivery based on continuous glucose monitoring and have shown improved glycemic outcomes. 2) GLP-1 receptor agonists, such as semaglutide and liraglutide, which improve glycemic control and induce weight loss. These therapies offer potential benefits in managing both glycemic variability and symptoms related to pancreatic exocrine insufficiency.

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Pancreatic Enzyme Replacement

Pancreatic Enzyme Replacement Therapy for Type 1 Diabetes (CREON Trial)

Q: What is the mechanism of action of this treatment?

The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas is unable to produce, thereby regulating blood glucose levels and preventing complications. Additionally, Pancreatic Enzyme Replacement Therapy (PERT), such as CREON, is being studied for its potential to improve glycemic control and reduce symptoms of pancreatic exocrine insufficiency by supplementing digestive enzymes. This is particularly important for T1D patients with reduced pancreatic volume and exocrine function, as it can enhance nutrient absorption and stabilize blood glucose levels.

Phase < 1

Waitlist Available

Led By Daniel Moore, MD, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total daily dose of insulin greater than 0.7u/kg/day

Reduction of pancreas volume (<0.6mL/kg body weight)

Must not have

History of celiac disease or inflammatory bowel disease

Use of medication or supplements other than insulin to control blood glucose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (4-5 weeks)

Summary

This trial is testing a medication that replaces missing digestive enzymes in people with Type 1 Diabetes who have a smaller pancreas. The goal is to help these patients better control their blood sugar and improve digestion.

Who is the study for?

This trial is for adults over 18 with Type 1 Diabetes, who've had it for at least a year, use a continuous glucose monitor and smartphone, and get care from the Eskind Diabetes Clinic. They should have reduced pancreas size and not be pregnant or breastfeeding, on restrictive diets, using other diabetes meds besides insulin, or have celiac or bowel disease.

What is being tested?

The study tests if CREON (pancreatic enzyme replacement) can help manage blood sugar in Type 1 Diabetes by improving glycemic response and reducing hypoglycemia compared to a placebo. Participants will provide data from their glucose monitors to see how well CREON works.

What are the potential side effects?

While specific side effects are not listed here, pancreatic enzyme replacements like CREON may cause digestive issues such as stomach pain, gas, bloating; allergic reactions; and changes in blood sugars.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use more than 0.7 units of insulin per kilogram of my body weight daily.

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My pancreas is smaller than usual for my body weight.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of celiac disease or inflammatory bowel disease.

Select...

I use medication or supplements, not including insulin, to manage my blood sugar.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (4-5 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (4-5 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (4-5 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in glucose regulation

Patient-reported change in pancreatic exocrine insufficiency (PEI) symptoms

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CREONActive Control1 Intervention

CREON is a pancreatic enzyme replacement

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas is unable to produce, thereby regulating blood glucose levels and preventing complications. Additionally, Pancreatic Enzyme Replacement Therapy (PERT), such as CREON, is being studied for its potential to improve glycemic control and reduce symptoms of pancreatic exocrine insufficiency by supplementing digestive enzymes. This is particularly important for T1D patients with reduced pancreatic volume and exocrine function, as it can enhance nutrient absorption and stabilize blood glucose levels.

Progress in the development of immune-based therapies for type 1 diabetes mellitus.[Conservative treatment of chronic pancreatitis].Interactions between the endocrine and exocrine pancreas and their clinical relevance.