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Early CGM-guided education and initiation of insulin therapy. for Type 1 Diabetes (TESS Trial)

N/A
Waitlist Available
Led By Brigitte I Frohnert, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for months 0, 1, 2, 3, 4, 5, and 6 of study
Awards & highlights

TESS Trial Summary

This trial is testing whether a protocol of close monitoring and education can reduce HbA1c levels and the risk of DKA at diagnosis in children with pre-symptomatic type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes
  • Hyperglycemia or Hypoglycemia
  • Prediabetes

TESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for months 0, 1, 2, 3, 4, 5, and 6 of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for months 0, 1, 2, 3, 4, 5, and 6 of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Diabetes Knowledge from baseline to 6 month follow-up.
Continuous glucose monitor (CGM) % time >140 mg/dL
Secondary outcome measures
% with HbA1c <7.0%
Change in C-peptide response to Oral Glucose Tolerance Test (OGTT)
Change in HbA1c
+7 more
Other outcome measures
Accuracy of parental risk perception.
Activity Monitoring daily steps
Adverse events
+20 more

TESS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Early diabetes management and education including focused education based on pathophysiology of type 1 diabetes, factors which impact blood glucose, and effects of insulin using data from continuous glucose monitoring device (CGM) worn unblinded at least 20 days per month with interpretation and education on results. Early initiation of insulin therapy, when warranted based on a pattern of prolonged or repeated high blood glucose values.
Group II: ControlActive Control1 Intervention
Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK (ongoing studies at BDC). This includes: blood glucose checks 2-3 times per month, participant-led contact with study personnel when abnormalities are noted and transition to clinical care when criteria for clinical type 1 diabetes are met.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,499 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,834 Total Patients Enrolled
Brigitte I Frohnert, MD, PhDPrincipal InvestigatorBarbara Davis Center for Diabetes, University of Colorado

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main aims of this clinical trial?

"The primary purpose of the clinical trial, which is to be analysed at baseline and 3, 6, 9 and 12 months intervals, is to evaluate any changes in Diabetes Knowledge from baseline up until the six month follow-up. Secondary objectives include determining what percentage of participants have an HbA1c <7.0%, as well as collecting Continuous Glucose Monitor (CGM) standard deviation sensor glucose level (mg/dL) and coefficient of variation data for Dexcom G6 wear with a minimum 5 days' worth of information."

Answered by AI

Are there any spots left for volunteers in this investigation?

"This particular clinical trial is not currently accepting any new participants, as evidenced by the last update that was made to its profile on May 6th 2022. However, there are 1,388 other medical studies actively recruiting patients at this moment."

Answered by AI

Does the research accommodate individuals above a certain age?

"In compliance with this trial's criteria for participation, children aged 2-20 are eligible to enroll."

Answered by AI

Am I eligible to be a participant in this research project?

"This clinical trial is recruiting up to 84 patients aged 2-20 with prediabetic conditions. Eligibility criteria include having participated in screening studies at the Barbara Davis Center (ASK, DAISY, TrialNet and TEDDY) with permission for contact regarding study opportunities; showing positive results of multiple islet autoantibodies or high affinity single antibodies at two visits or more; meeting fasting plasma glucose levels between 100-125 mg/dL OR a 2 hour OGTT plasma glucose level of 140-199 mg/dL OR an A1c score of 5.7 - 6.4% OR an increase from previous visit"

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D
2020. "Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335513.
~17 spots leftby Apr 2025
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