InsuLearn for Type 1 Diabetes

(InsuLearn Trial)

Overseen By Sara Prince, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Virginia

Must be taking: Insulin

Must not be taking: NPH insulin, Seizure medications

Disqualifiers: Seizure disorder, Adrenal disorder, Liver, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use NPH insulin or any non-insulin glucose-lowering agents like GLP-1 receptor agonists, pramlintide, and SGLT2 inhibitors. Other medications may be excluded if the investigator thinks they could interfere with the trial.

What data supports the effectiveness of the treatment InsuLearn for Type 1 Diabetes?

The study on Insulclock, a device to improve insulin management, showed that it helped people with type 1 diabetes better control their blood sugar levels and increased their satisfaction with treatment. This suggests that similar tools or treatments like InsuLearn might also be effective in managing type 1 diabetes. ^{1 2 3 4 5}

What safety data exists for InsuLearn or similar treatments for type 1 diabetes?

There is no specific safety data available for InsuLearn, but studies on similar treatments like insulin pumps and basal insulins show that adverse events can occur, such as hypoglycemia (low blood sugar), injection site issues, and insulin allergies. These treatments are generally considered safe, but improvements are needed to reduce risks like hypoglycemia and other complications. ^{6 7 8 9 10}

How does the InsuLearn treatment differ from other treatments for type 1 diabetes?

InsuLearn appears to be a novel treatment for type 1 diabetes, potentially involving a digital or electronic component to improve insulin management, similar to Insulclock, which enhances treatment adherence and insulin tracking. This approach may offer unique benefits in managing blood sugar levels and increasing patient satisfaction compared to traditional insulin therapies. ^{2 4 5 11 12}

Research Team

Anas Fathi, PhD

Principal Investigator

University of Virginia Center for Diabetes Technology

Eligibility Criteria

This trial is for adults over 18 with Type 1 Diabetes who have been on multiple daily insulin injections for at least six months, have a Hemoglobin A1c between 7.0% - 10.0%, and struggle with carbohydrate counting. They must be able to use the internet, wear a continuous glucose monitor, and if female and sexually active, agree to use contraception.

Inclusion Criteria

Hemoglobin A1c (HbA1c) between 7.0% - 10.0%

I have been using insulin injections multiple times a day for at least 6 months.

Poor carbohydrate counting based on their score on the AdultCarbQuiz (a score lower of 33/43)

Exclusion Criteria

Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L)

Abuse of alcohol or recreational drugs

I use NPH insulin for my diabetes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Participants use the InPen™ app to log and deliver insulin doses at home

4 weeks

Home-based data collection

Intervention

Participants undergo a 24-hour supervised intervention with standardized meals and insulin dose adjustments

2 days

2 visits (in-person, hotel admission)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1-2 weeks

Treatment Details

Interventions

• InsuLearn (Behavioural Intervention)

Trial Overview The InsuLearn intervention is being tested against usual care in people with Type 1 Diabetes. It involves optimizing insulin doses based on data from a home monitoring period of four weeks. Participants are randomly assigned to start with either InsuLearn or their regular treatment.

Participant Groups

Group I: InsuLearn→Usual Care Active Control 1 Intervention

During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by the InsuLearn, MD approved, report. The second 24 hours of the hotel admission (visit 7), participants will use their usual care method to calculate their insulin dose.

Group II: Usual Care→InsuLearn Active Control 1 Intervention

During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by their usual care method. The second 24 hours of the hotel admission (visit 7), participants will use the InsuLearn, MD approved, report to calculate their insulin dose.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

In a study of 29 young adults with type 1 diabetes, the wireless OmniPod™ Insulin Management System was found to be well-received, with 76% of participants preferring its automated cannula insertion over conventional insulin pumps.

The OmniPod system led to a greater reduction in HbA1c levels compared to conventional insulin pumps, indicating it may provide better glycemic control for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. Lebenthal, Y., Lazar, L., Benzaquen, H., et al.[2022]

The use of the Insulclock® device led to significant improvements in glycemic control for patients with uncontrolled type 1 diabetes, including a decrease in mean glucose levels and glucose variability, as well as an increase in time spent within the target glucose range.

Patients using the Insulclock® reported better treatment adherence and satisfaction, with a notable reduction in missed and mistimed insulin doses, suggesting that the device could enhance overall diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial. Gomez-Peralta, F., Abreu, C., Gomez-Rodriguez, S., et al.[2021]

In a 28-week study involving adults with type 1 diabetes, switching to insulin glargine 300 U/mL once daily significantly improved glycated hemoglobin (HbA1c) levels, reducing the average from 8.54% to 8.27%.

Participants also reported higher treatment satisfaction, as indicated by significant improvements in the Diabetes Treatment Satisfaction Questionnaire scores, while the study showed no significant increase in hypoglycemia events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL in People with Type 1 Diabetes on Basal-Bolus Insulin: Phase 4 OPTIMIZE Study. Mathieu, C., Weisnagel, SJ., Stella, P., et al.[2020]

In a study involving 66 youth with type 1 diabetes, the use of the Insuflon injection port significantly improved glycemic control, as indicated by lower HbA1c levels compared to a control group at both 3 and 6 months.

Participants using the Insuflon saw their HbA1c levels decrease from 9.4% at the start to 8.7% at 3 months and 8.5% at 6 months, while no significant changes were observed in the control or alarm groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a subcutaneous injection port to improve glycemic control in children with type 1 diabetes. Burdick, P., Cooper, S., Horner, B., et al.[2022]

In a study of 484 patients with type 2 diabetes using the Insulia app for at least 6 months, 60% of regular users achieved their target fasting blood glucose levels, indicating effective glycemic control without increasing the risk of hypoglycemia.

The average hemoglobin A1c level significantly decreased from 9.9% to 7.2% over 6 months among users, demonstrating the app's efficacy in managing diabetes through personalized insulin dosing recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of an App (Insulia) in Recommending Basal Insulin Doses for French Patients With Type 2 Diabetes Mellitus: Longitudinal Observational Study. Nevoret, C., Gervaise, N., Delemer, B., et al.[2023]

SGLT2 inhibitors significantly lower key diabetes markers in type 1 diabetes patients, including glycated hemoglobin (HbA1c) and fasting plasma glucose, while also reducing body weight and total insulin dosage, based on a meta-analysis of 16 randomized controlled trials involving 7192 patients.

Importantly, the use of SGLT2 inhibitors does not increase the risk of hypoglycemia, urinary tract infections, or diarrhea, suggesting they can be safely integrated into treatment regimens for type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. Nan, J., Wang, D., Zhong, R., et al.[2023]

In a study involving 174 participants with Type 1 Diabetes Mellitus (T1DM) using insulin pumps, 84% reported experiencing at least one adverse event (AE), with an incidence rate of 3.42 AEs per person per year.

The most common AEs were related to infusion set/site issues (53%), cutaneous complications (43%), and pump malfunction (38%), indicating that while AEs are frequent, few factors predict their occurrence, emphasizing the need for patient education on managing these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump-associated adverse events are common, but not associated with glycemic control, socio-economic status, or pump/infusion set type. Ross, P., Gray, AR., Milburn, J., et al.[2022]

In a study of patients with type 1 diabetes, those using insulin glargine 300 U/mL (IG300) and insulin degludec (ID) showed similar long-term safety and efficacy compared to those continuing with insulin glargine 100 U/mL (IG100), with low rates of severe hypoglycemia and stable HbA1c levels over an average follow-up of 1.1 to 1.6 years.

Patients on IG100 experienced higher rates of severe adverse events and mortality (1.95%) compared to those on IG300 (0.7%) and ID (0.8%), suggesting that IG300 and ID may offer better safety profiles for long-term management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Treatment with New Basal Insulin Analogues in Type 1 Diabetes: Nation-Wide Survey. Svensson, AM., Ekelund, J., Miftaraj, M., et al.[2020]

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]

Insulin treatment for diabetes can lead to various adverse events, including hypoglycemia, injection site issues, insulin allergy, and even increased risks of obesity and certain cancers, highlighting the need for better insulin formulations.

There is a significant opportunity to improve insulin therapies by developing formulations with more predictable absorption and kinetics, which could lead to better blood glucose control and reduced risks of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin Adverse Events. Ludvigsson, J.[2020]

In a study involving 169 patients with type 1 diabetes, Insuman was shown to be noninferior to Insuplant in terms of safety and effectiveness when used in implanted insulin pumps, with similar changes in HbA1c levels and infusion accuracy.

Both insulin preparations resulted in comparable rates of severe hypoglycemia and other adverse events, indicating that Insuman can be a safe alternative to Insuplant for long-term glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Schaepelynck, P., Riveline, JP., Renard, E., et al.[2022]

The INSULIA app for insulin titration in type 2 diabetes patients was found to enhance patient involvement and confidence in managing their insulin therapy, as reported by physicians.

Patients using the app achieved better fasting blood glucose (FBG) and HbA1c target levels more frequently and experienced fewer hypoglycemic episodes compared to those not using the app, indicating its efficacy in improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based Application to Assist Insulin Titration in Patients Undergoing Basal Insulin-Supported Oral Antidiabetic Treatment. Tews, D., Gouveri, E., Simon, J., et al.[2023]

References

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

Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. [2022]

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

Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial. [2021]

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

Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL in People with Type 1 Diabetes on Basal-Bolus Insulin: Phase 4 OPTIMIZE Study. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

Use of a subcutaneous injection port to improve glycemic control in children with type 1 diabetes. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

The Effectiveness of an App (Insulia) in Recommending Basal Insulin Doses for French Patients With Type 2 Diabetes Mellitus: Longitudinal Observational Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Insulin pump-associated adverse events are common, but not associated with glycemic control, socio-economic status, or pump/infusion set type. [2022]

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

Efficacy and Safety of Treatment with New Basal Insulin Analogues in Type 1 Diabetes: Nation-Wide Survey. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

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

10. Israel pubmed.ncbi.nlm.nih.gov

Insulin Adverse Events. [2020]

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

Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. [2022]

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

A Smartphone-Based Application to Assist Insulin Titration in Patients Undergoing Basal Insulin-Supported Oral Antidiabetic Treatment. [2023]