Mobile Health Program for Low Blood Sugar Management

Overseen By Emily Hepworth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Adrenal insufficiency, Hypothyroidism, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health program called HypoPals, designed to help people with type 1 diabetes better detect and manage low blood sugar levels. Participants will receive various types of text message support, including training on recognizing symptoms and educational content, to determine which is most effective. Individuals who have had type 1 diabetes for at least 5 years, use a continuous glucose monitor, and have experienced severe low blood sugar may be suitable candidates. The goal is to ensure the program runs smoothly and proves helpful before conducting a larger study. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative tools for diabetes management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile health program and continuous glucose monitoring, so you may not need to change your medications.

What prior data suggests that the HypoPals mobile health program is safe for managing low blood sugar?

Research shows that specific safety information for the HypoPals mobile health program is not yet available. However, studies on similar smartphone apps for managing diabetes have not identified any major safety issues. These apps typically assist users in controlling blood sugar by offering helpful tips and reminders.

This trial is a pilot study, testing the program's effectiveness and user satisfaction. As the study is in an early stage, safety information may be limited. However, since the program primarily involves sending text messages and providing education, the risks are likely low.

For any concerns about joining, consulting a healthcare provider is advisable. They can help determine if this trial is suitable for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Program for Low Blood Sugar Management because it offers a fresh approach to managing hypoglycemia using digital tools and education. Unlike standard treatments that typically involve medication and diet adjustments, this trial explores the effectiveness of mobile health interventions like HypoPals. The trial includes innovative strategies such as Hypoglycemia Symptom Detection Training and an Education Plus program, aiming to empower patients with real-time symptom awareness and personalized education. By combining technology with education, these interventions have the potential to enhance self-management and improve outcomes for those experiencing low blood sugar episodes.

What evidence suggests that this trial's treatments could be effective for low blood sugar management?

Research shows that HypoPals, a mobile health program, was designed to help people manage low blood sugar by sending personalized text messages. Although its effectiveness has not been officially tested, it employs methods similar to those proven promising in past studies. This trial includes various treatment arms, such as "Hypoglycemia Symptom Detection Training" and "Education Plus," which may incorporate elements from programs like BGAT and HARPdoc. These programs have helped people recognize symptoms and understand the psychological aspects of health, reducing severe low blood sugar by over 50%. This suggests that HypoPals might enable users to detect and manage symptoms more effectively. The program also uses continuous glucose monitoring systems, which further supports its potential effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Yu Kuei Alex Lin, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people with Type 1 Diabetes who've had severe low blood sugar in the past year or frequent low sugars, use a Dexcom CGM regularly, have completed diabetes education, and can read English texts. They should be willing to share glucose data and not be pregnant or planning pregnancy soon, have untreated hormonal issues, uncontrolled mental disorders, cognitive dysfunctions or be in other diabetes studies.

Inclusion Criteria

I am willing to follow the study's rules, share my glucose data, get texts, and fill out questionnaires.

You have had very low blood sugar episodes while using CGMs or spend a lot of time with low blood sugar levels.

You have a cellphone that can share data to Dexcom Clarity and receive text messages.

Exclusion Criteria

I have untreated adrenal or thyroid issues.

You are currently taking part in a study related to diabetes or low blood sugar treatments.

You have a mental disorder or cognitive dysfunction that is not being controlled with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive basic hypoglycemia education text messages and are randomized to one of four experimental conditions, receiving additional interventional text messages based on their assigned condition.

12 weeks

Follow-up

Participants are monitored for feedback on the helpfulness of message content and overall intervention effectiveness.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HypoPals

Trial Overview

The 'HypoPals' mobile health program uses continuous glucose monitoring data to send personalized texts aiming to improve hypoglycemia management. Participants will get basic education messages plus additional training based on their group assignment after being randomly placed into one of four groups: detection training only, advanced education only, both trainings or usual care.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Continuing usual care after basic education.

Group II: Hypoglycemia Symptom Detection Training and Education Plus Experimental Treatment 3 Interventions

To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.

Group III: Hypoglycemia Symptom Detection Training Experimental Treatment 2 Interventions

To provide Hypoglycemia Symptom Detection Training intervention.

Group IV: Education Plus Experimental Treatment 2 Interventions

To provide Education Plus intervention.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Sugar Sleuth mobile app, used alongside the FreeStyle Libre™ glucose sensor, led to a significant average reduction in A1c levels by 0.5% over 14 weeks in adults with type 1 diabetes, indicating improved glycemic control.

Participants also reported a decrease in daily carbohydrate intake by an average of 43 grams, suggesting that the app effectively supported dietary management, although no significant changes were observed in other glycemic metrics or insulin dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. Toschi, E., Fisher, L., Wolpert, H., et al.[2019]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Citations

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An mHealth Text Messaging Program Providing Symptom ...

HypoPals's efficacy in reducing hypoglycemia has not been formally tested [77]. The program may affect users differently according to their hypoglycemia-related ...

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withpower.com

withpower.com/trial/phase-diabetes-mellitus-type-1-6-2023-d56f5

Mobile Health Program for Low Blood Sugar Management

What data supports the effectiveness of the treatment HypoPals for low blood sugar management? The study on diabetes self-management education and medical ...

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researchgate.net/publication/372022071_Development_of_HypoPals_A_Mobile_Health_Text_Messaging_Program_Providing_Hypoglycemia_Symptom_Detection_Training_and_Hypoglycemia_Psychoeducation_to_Improve_Hypoglycemia_Self-Management_Preprint

A Mobile Health Text Messaging Program Providing ...

This program was systematically developed to improve hypoglycemia self-management in advanced diabetes technology users with T1D. A clinical trial is needed to ...

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researchgate.net

researchgate.net/figure/Examples-of-HypoPals-hypoglycemia-psychoeducation-messages-A-A-message-eliciting_fig3_374445002

Examples of HypoPals hypoglycemia psychoeducation ...

Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P < 0.0001) and yielded improvements ...

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An mHealth Text Messaging Program Providing Symptom ...

This program was systematically developed to improve hypoglycemia self-management in advanced diabetes technology users with T1D. A clinical ...

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cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/31/NCT05916131/ICF_001.pdf

Pilot Feasibility Study for HypoPals, a Mobile Health ...

Our recent research showed that whether people feel their low blood sugar symptoms and how people think of low blood sugar are important to their management of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8696639/

Hypoglycemia in diabetes: An update on pathophysiology, ...

The HypoDE trial showed that the use of CGM significantly reduced hypoglycemia rate in adult patients with type 1 diabetes with a history of hypoglycemia ...

8.

diabetesjournals.org

diabetesjournals.org/care/article/48/Supplement_1/S128/157561/6-Glycemic-Goals-and-Hypoglycemia-Standards-of

6. Glycemic Goals and Hypoglycemia: Standards of Care in ...

Hypoglycemia is often the major limiting factor in the glycemic management of type 1 and type 2 diabetes. Recommendations regarding the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9888015/

Managing Severe Hypoglycaemia in Patients with Diabetes

Hypoglycemia can lead to acute and permanent neurological complications. Thus, addressing this severe clinical issue is paramount from the ...