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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment HypoPals for low blood sugar management?

The study on diabetes self-management education and medical nutrition therapy shows that education and nutrition interventions can improve outcomes for diabetes patients, which may suggest that similar educational components in HypoPals could be effective for managing low blood sugar. ^{1 2 3 4 5}

Is the Mobile Health Program for Low Blood Sugar Management safe for humans?

The available research does not provide specific safety data for the Mobile Health Program or HypoPals, but studies on similar smartphone applications for managing low blood sugar in diabetes patients have not reported any safety concerns. These studies focus on reducing hypoglycemia (low blood sugar) and improving awareness, which suggests a focus on safety and patient well-being. ^{6 7 8 9 10}

How does the Mobile Health Program for Low Blood Sugar Management differ from other treatments for low blood sugar?

The Mobile Health Program for Low Blood Sugar Management is unique because it uses a smartphone app to log and manage hypoglycemic symptoms, causes, and treatments, which can help reduce hypoglycemia in people with type 1 diabetes. This approach is different from traditional treatments as it focuses on real-time data management and self-care through technology, potentially increasing ease of use and satisfaction. ^{6 9 11 12 13}

What is the purpose of this trial?

A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to. The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).

Research Team

Yu Kuei Alex Lin, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Documented hypoglycemia is associated with poor short and long term prognosis among patients admitted to general internal medicine departments. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patient and paramedic experiences with a direct electronic referral programme for focused hypoglycaemia education following paramedic service assist-requiring hypoglycaemia in London and Middlesex County, Ontario, Canada. [2022]

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

Diabetes Self-Management Education and Medical Nutrition Therapy Improve Patient Outcomes: A Pilot Study Documenting the Efficacy of Registered Dietitian Nutritionist Interventions through Retrospective Chart Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol. [2020]

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

Use of a Smartphone Application to Reduce Hypoglycemia in Type 1 Diabetes: A Pilot Study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution. [2021]

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

Impact of a hypoglycemia reduction bundle and a systems approach to inpatient glycemic management. [2022]

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

Effectiveness of HypoAware, a Brief Partly Web-Based Psychoeducational Intervention for Adults With Type 1 and Insulin-Treated Type 2 Diabetes and Problematic Hypoglycemia: A Cluster Randomized Controlled Trial. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Hypoglycemia evaluation and reporting in diabetes: Importance for the development of new therapies. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Reduced Worries of Hypoglycaemia, High Satisfaction, and Increased Perceived Ease of Use after Experiencing Four Nights of MD-Logic Artificial Pancreas at Home (DREAM4). [2019]

12. United States 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. [2018]

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

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. [2019]