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Behavioral Intervention

Smartphone App for Type 2 Diabetes (REFLECT2D Trial)

N/A

Waitlist Available

Led By Mary Ellen Vajravelu, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Type 2 diabetes with negative diabetes autoantibodies and no suspicion for monogenic diabetes

HbA1c 6.0-6.9% without short-acting insulin, with stable use of any other diabetes medication for at least 3 months

Must not have

Hydroxyurea use leading to CGM sensor inaccuracies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; 6 months average

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a smartphone app that provides real-time data on blood sugar levels and health behaviors can help adolescents and young adults with type 2 diabetes better control their blood sugar. Participants

Who is the study for?

This trial is for adolescents and young adults with Type 2 Diabetes who are interested in managing their blood sugar levels using technology. Participants should be comfortable using a smartphone app, a Fitbit activity tracker, and Continuous Glucose Monitors (CGM). Specific eligibility criteria were not provided.

What is being tested?

The study tests if an app that prompts users to check real-time blood sugar and health behavior data helps control Type 2 Diabetes better. Half will get these prompts; the other half won't. Everyone's monitored for 90 days then observed for another 90 without prompts.

What are the potential side effects?

Since this trial involves non-invasive technology like apps and trackers rather than medication, typical medical side effects aren't expected. However, participants may experience stress or anxiety from constant health monitoring.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have type 2 diabetes without any autoimmune or genetic diabetes conditions.

Select...

My HbA1c is between 6.0-6.9% and I haven't used short-acting insulin, but have been on stable diabetes medication for 3 months.

Exclusion Criteria

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

Select...

I am taking hydroxyurea, which affects my CGM sensor readings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 6 months average

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 6 months average

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 6 months average for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Capability

Continuous glucose monitor use use

Diet quality

+13 more

Secondary study objectives

Body Mass Index (BMI)

Diabetes distress

Diabetes family support and conflict

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Physical Activity Focused App PromptExperimental Treatment1 Intervention

The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.

Group II: No App PromptExperimental Treatment1 Intervention

No app prompt will be sent to the participant

Group III: Diet Focused App PromptExperimental Treatment1 Intervention

The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.

0 / 3Eligibility criteria met