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Type 1 DiabetesTESSNCT04335513

Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D

A study testing Early CGM-guided education and initiation of insulin therapy. in people with Type 1 Diabetes and Prediabetic State, run by University of Colorado, Denver at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. Read more about this study

Who is it for?
Ages 2 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes, Prediabetic State, Dysglycemia
What is being tested?
Early CGM-guided education and initiation of insulin therapy.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
30 Apr 2020to 31 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult
  1. Individuals identified in stage 2 T1D through ongoing screening studies at the Barbara Davis Center (ASK, DAISY, TrialNet, and TEDDY) who have given permission to be contacted about study opportunities.
  2. Presence of islet autoimmunity with high risk of progression:
  3. positive for multiple islet autoantibodies at 2 or more visits -OR- ii. positive for a single high-affinity islet autoantibody at 2 or more visits
  4. Evidence of dysglycemia (Stage 2 T1D) using any one of the following criteria:
  5. Americal Diabetes Association (ADA) criteria:
  6. fasting plasma glucose 100-125 mg/dL
  7. OR 2-hour OGTT plasma glucose of 140-199 mg/dL
  8. OR A1c 5.7-6.4%
  9. OR ≥10% increase in A1c from previous visit

II. Dysglycemia on OGTT (TrialNet Criteria):

  1. glucose above 200 mg/dL on 30, 60 OR 90 minute values

III. Dysglycemia on CGM worn for at least 5 days:

  1. ≥15% of values above 140 mg/dL
  2. OR peaks ≥ 200 mg/dL on ≥2 days
  3. OR average sensor glucose ≥120 mg/dL

IV. Dysglycemia on finger stick blood glucose:

  1. Fasting BG above 110 mg/dL on 2 or more days
  2. OR 2 hour post-meal BG above 150 mg/dL on ≥ 2 days
  3. OR single random BG > 200 mg/dL

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Davis Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.

Read the detailed description

Specific Aims:

Perform randomized controlled trial of intensive follow-up of stage 2 T1D participants utilizing continuous glucose monitoring (CGM) technology and early education of families to guide early insulin therapy with the goals of:

maintaining HbA1c less than 7.0%. avoiding adverse outcomes: ER visits, hospitalizations, DKA and severe hypoglycemia improving diabetes knowledge through optimal planned education as opposed to 'a crash course' at unexpected diagnosis event.

evaluating patient/caregiver satisfaction with diabetes care received evaluating impact of activity on glycemic profile Collect longitudinal biomarkers of beta-cell stress and dysfunction in stage 2 T1D.

Use longitudinal CGM data combined with "gold-standard" OGTT and HbA1c measures to provide evidence for CGM-based diagnostic criteria for stage 2 and stage 3 T1D.

Perform cost-analysis of intensive follow up protocol.

Being tested
Early CGM-guided education and initiation of insulin therapy., Usual care: glucometer surveillance and basic education.
Keywords
Islet autoimmunity
Medical subject headings
Diabetes Mellitus, Type 1, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early CGM-guided education and initiation of insulin therapy.Other

    Careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, staged education targeted to assist families in recognizing evolving dysglycemia, and addressing glycemic abnormalities with early initiation of insulin can substantially reduce the HbA1c and risk of DKA at diagnosis, thereby changing the trajectory of the disease course.

  • Usual care: glucometer surveillance and basic education.Other

    • Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK.
    • Blinded CGM for 10 days every 3 months to collect data on glycemic profile with basic feedback regarding changes.
Study groups in NCT04335513
Study groupRoleWhat they receive
InterventionExperimentalEarly 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.
Receives: Other: Early CGM-guided education and initiation of insulin therapy.
ControlActive comparatorUsual 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.
Receives: Other: Usual care: glucometer surveillance and basic education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Diabetes Knowledge from baseline to 6 month follow-up.

    35-item diabetes questionnaire with possible responses true/false/don't know. Total score is the number of correct answers out of 35, with more correct answers indicating higher knowledge. Change from baseline to 6-month follow-up will be compared between groups

    Measured: Baseline, 6 months

  2. Continuous glucose monitor (CGM) % time >140 mg/dL

    Data obtained for Dexcom G6 wear with at least 5 days of data at each time point. Continuous glucose monitor (CGM) % time >140 mg/dL will be analyzed using linear mixed models incorporating data from all 5 time points, with an interaction between group and time to test for differences in change in outcome over time. Contrast statements will be used to test for comparisons of intervention vs controls.

    Measured: Baseline and 3, 6, 9 and 12 months

Secondary outcomes (10)

  1. Change in HbA1c

    HbA1c from baseline to 52 weeks, adjusted for baseline

    Measured: Baseline and 3, 6, 9 and 12 months

  2. % with HbA1c <7.0%

    Percentage of individuals in each group with HbA1c <7.0%

    Measured: Baseline and 3, 6, 9 and 12 months

  3. Continuous glucose monitor (CGM) % time in range 60-140 mg/dL

    Data obtained for Dexcom G6 wear with at least 5 days of data.

    Measured: Baseline and 3, 6, 9 and 12 months

  4. Continuous glucose monitor (CGM) mean sensor glucose level (mg/dL)

    Data obtained for Dexcom G6 wear with at least 5 days of data.

    Measured: Baseline and 3, 6, 9 and 12 months

  5. Continuous glucose monitor (CGM) standard deviation sensor glucose level (mg/dL)

    Data obtained for Dexcom G6 wear with at least 5 days of data.

    Measured: Baseline and 3, 6, 9 and 12 months

  6. Continuous glucose monitor (CGM) coefficient of variation sensor glucose level (mg/dL)

    Data obtained for Dexcom G6 wear with at least 5 days of data.

    Measured: Baseline and 3, 6, 9 and 12 months

  7. Change in Pediatric Quality of Life Inventory (PedsQL 4.0) score over time

    The PedsQL 4.0 measures health-related quality of life across the domains of Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning.

    ThePedsQL has parallel forms for parents of children aged 2-4, 5-7, 8-12, and 13-18 years. The child version has parallel forms for children aged 5-7, 8-12, and 13-18. Responses to items use a 5-point Likert scale (0 = never a problem, 4 = almost always a problem). Items are reverse scored and transformed to a 0 to 100 scale with higher scores indicating better quality of life.

    Measured: Baseline and 3, 6, 9 and 12 months

  8. Change in C-peptide response to Oral Glucose Tolerance Test (OGTT)

    C-peptide measurement during standard OGTT, Area under the curve (AUC)

    Measured: Baseline, 6 months, 12 months

  9. Change in insulin response to Oral Glucose Tolerance Test (OGTT)

    insulin measurement during standard OGTT, Area under the curve (AUC)

    Measured: Baseline, 6 months, 12 months

  10. Diabetes attitude survey change over time

    10 item survey, each item answered on a likert scale from 1-5: (1) strongly disagree to (5) strongly agree. Scoring is on 4 scales: (1) "Value of Tight Control", scored on 4-20 points with higher score indicating agreement with importance of control; (2) "Psychosocial Impact", scored on 2-10 points with higher score indicating agreement with high impact of diabetes on psychosocial factors; (3) "Patient Autonomy", scored on 2-10 points with higher score indicating agreement with value of autonomy; and (4) "Confidence", scored on 2-10 points with higher score indicating confidence in knowledge and skills.

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start30 Apr 2020
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335513
Sponsor's protocol ID
19-1767
Acronym
TESS
Status last verified
May 2022
First submitted
17 Mar 2020
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Early CGM-guided education and initiation of insulin therapy. in people with Type 1 Diabetes and Prediabetic State, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Diabetes Knowledge from baseline to 6 month follow-up. (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04335513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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