AzTrials
AzTrials

Type 1 Diabetes MellitusNCT02734667

Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

A study testing CGM at diagnosis of T1D in people with Type 1 Diabetes Mellitus, run by Korey Hood at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
CGM at diagnosis of T1D
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
Feb 2016to Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • To be eligible for the study, a child must meet the following criteria:
  • Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
  • Time since diagnosis of no longer than one month
  • Age between 2 and 17 years
  • Parental consent (and assent from the child where applicable) to participate in the study
  • No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
Show all 11Show fewer
  • To be eligible for the study, a parent must meet the following criteria:
  • Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
  • Age of 18.0 years or older
  • Parent comprehends written English
  • Parent understands the study protocol and signs the informed consent document

Who cannot join

  • The presence of any of the following is an exclusion for the study:
  • Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
  • Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
  • Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  • Child is unable to completely avoid acetaminophen for duration of study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.

Read the detailed description

Synopsis of study protocol

This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first six months after diagnosis, the investigators will conduct a longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18 months. The CGM system used in this study is the Dexcom G5 System with the Share function (FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner. Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments conducted every six months until participants are two years post-diagnosis.

Study Procedures

Participants will be recruited at two centers: Stanford University and the Barbara Davis Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or within 1 month of diagnosis. Once identified, study staff will approach potential participants to explain the study, determine eligibility, and obtain informed consent. Once enrolled in the study, participants will be randomized. Participants will be randomized at a 2:1 ratio, intervention to control. The investigators will also stratify by age group to ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11, and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6 years group will not begin until the investigators have at least 2 weeks of non-adjunctive CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling participants in the youngest age group.

Being tested
CGM at diagnosis of T1D
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • CGM at diagnosis of T1DDevice

    Initiation of non-adjunctive CGM use at diagnosis of T1D

Study groups in NCT02734667
Study groupRoleWhat they receive
CGM at diagnosis of T1DExperimentalParticipants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
Receives: Device: CGM at diagnosis of T1D
Usual CareNo interventionParticipants receive usual care for T1D for 6 months post diagnosis.

What is being measured

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

  1. Time Spent in Blood Glucose Range (70-180mg/dL)

    Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.

    Measured: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point

  2. Glucose Monitoring Satisfaction Survey (GMSS) - Parent

    The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction.

    Measured: Baseline, 24 months

  3. Time Spent in Hypoglycemia (< 70 mg/dL)

    Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point.

    Measured: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point

Secondary outcomes (13)

  1. Pediatric Quality of Life Inventory

    This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life.

    Measured: Baseline, 24 months

  2. Problem Areas in Diabetes Score

    Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems.

    Measured: Baseline, 24 months

  3. Diabetes Distress Scale

    This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress.

    Measured: Baseline, 24 months

  4. Patient Health Questionnaire 9

    This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms.

    Measured: Baseline, 24 months

  5. State-Trait Anxiety Inventory

    This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety.

    Measured: Baseline, 24 months

  6. Pittsburgh Sleep Quality Index

    This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality.

    Measured: Baseline, 24 months

  7. Hypoglycemic Fear Survey

    People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia.

    Measured: Baseline, 24 months

  8. Hypoglycemic Confidence Questionnaire

    Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia.

    Measured: Baseline, 24 months

  9. General and Diabetes-specific Technology Use

    This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology.

    Measured: Baseline, 24 months

  10. Center for Epidemiologic Studies Depression Measure

    This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms.

    Measured: Baseline, 24 months

  11. Child Health Utility 9D

    Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented.

    Measured: Baseline, 24 months

  12. Hemoglobin A1c

    The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.

    Measured: Baseline, 24 months

  13. C-peptide

    This is a biologic measure of endogenous production and is collected through a blood sample.

    Measured: Baseline, 24 months

Timeline

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

  1. First posted12 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734667
Sponsor's protocol ID
35990
Status last verified
Feb 2022
First submitted
9 Mar 2016
Last updated
2 Mar 2022
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CGM at diagnosis of T1D in people with Type 1 Diabetes Mellitus, run by Korey Hood at 2 sites 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?

The sponsor lists 11 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time Spent in Blood Glucose Range (70-180mg/dL) (time frame: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point). The study lists 3 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 NCT02734667.

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 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in