Health TrialsbyHealthPanel

Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

ConditionDiabetes Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScripps Whittier Diabetes Institute

About this trial

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 2 diabetes

Are not currently using a CGM

Are not using insulin therapies

Speak English, Spanish or Arabic

Disqualifiers

Are using insulin therapies

Are pregnant

Are currently using a CGM

Are currently participating in another diabetes-related study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dulce Digital Text Messaging Intervention

    Other intervention

    Text-based education support program: * Participants will receive text messages about diabetes and how to take care of diabetes and health. Participants will receive 2-3 messages every day for first 3 months, and then will slowly decrease over the last 3-months. * Participants will also receive text messages that will ask them to test their blood sugar and text back blood sugar reading.

  • CGM Device

    Other intervention

    Participants will be provided continuous glucose monitors (Dexcom G7) to actively monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 18 devices to last up to 6 months). In addition, participants will attend an information session (group or individual; in-person or virtual) that will provide instructions on using continuous glucose monitors.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: CGM GroupExperimental treatment 2 interventions
Group B: Usual Care Blood Glucose Monitoring GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Measures participants A1c using lab results provided from healthcare provider.

Time frame
6 months

Secondary outcomes

1

CGM Metric Time in Range

Measures the percentage of time a participant's blood glucose levels stay within the target range using CGM device.

Time frame
6 months
2

CGM Metric Time above Range

Measures the percentage of time a participant's blood glucose levels exceed the target range using CGM device.

Time frame
6 months
3

CGM Metric Time Below Range

Measures the percentage of time a participant's blood glucose levels fall below the target range using CGM device.

Time frame
6 months
4

Summary of Diabetes Self Care Activities (SDSCA) Survey

Summary of Diabetes Self Care Activities Survey measures frequency and consistency of diabetes self-care activities during the past 7 days. Possible scores range from 0 (0 Days to 7 (7 Days). Higher scores indicate better compliance with diabetes self-care.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scripps Whittier Diabetes Institute

Lead sponsor

Source ClinicalTrials.gov
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