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Diabetes self-management education for Type 2 Diabetes (IMMEDIATE Trial)

N/A
Waitlist Available
Led By Ronnie Aronson, MD
Research Sponsored by LMC Diabetes & Endocrinology Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A clinical diagnosis of T2D, with diagnosis known for six months or more;
An HbA1c of > 7.5%;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-week period
Awards & highlights

IMMEDIATE Trial Summary

This study is evaluating whether a flash glucose monitor device can help people with type 2 diabetes control their blood sugar.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes

IMMEDIATE Trial Eligibility Criteria

Inclusion Criteria

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

IMMEDIATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-week period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16-week period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in Range (TIR)
Secondary outcome measures
Adherence to diabetes medications as measured by the Adherence to Refills and Medication-Diabetes (ARMS-D)
Change in antihyperglycemic therapies
Change in waist circumference (cm)
+14 more
Other outcome measures
Exploratory analysis 1a: Glucose control - Targeted glucose range
Exploratory analysis 1b: Glucose control - hypoglycemia
Exploratory analysis 1c: Glucose control - hyperglycemia
+13 more

IMMEDIATE Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention (FGM + DSME)Experimental Treatment2 Interventions
Study participants randomized to the intervention arm will be provided with a FreeStyle Libre flash glucose monitor (FGM) system to use for 16 weeks in Phase 1. Study participants will receive one training session on proper use of the FGM and encouraged to test at least 4 times per day: fasting and post-meals. Participants will also receive six diabetes self-management education (DSME) sessions, consisting of four individual in-clinic sessions and two telephone sessions.
Group II: Control (DSME alone)Experimental Treatment1 Intervention
Study participants in the control arm will receive six diabetes self-management education sessions matched to time and location of the intervention group. The sessions will consist of four individual in-clinic sessions and two telephone sessions over 16 weeks. Control participants will be encouraged to self-monitor blood glucose four times daily (fasting and post-meals) as per existing diabetes self-care guidelines
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FreeStyle Libre Flash Glucose Monitor
2020
N/A
~120

Find a Location

Who is running the clinical trial?

LMC Diabetes & Endocrinology Ltd.Lead Sponsor
16 Previous Clinical Trials
22,767 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,653 Total Patients Enrolled
Ronnie Aronson, MDPrincipal InvestigatorLMC Diabetes
7 Previous Clinical Trials
10,335 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
2020. "Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04562714.
~25 spots leftby Apr 2025
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