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Type 1 Diabetes MellitusNCT03354286

Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System

A study testing Developmental & Technological Demands, Distress Reduction and Nutrition, Set Point, & C:I Ratio in people with Type 1 Diabetes Mellitus, run by Stanford University at 1 site in United States.

Completed

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

Official record
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Trial summary

This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D). Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Developmental & Technological Demands, Distress Reduction and Nutrition, Set Point, & C:I Ratio
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
7 Nov 2017to 18 Mar 2019
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 6 years
  • All sexes
  • No healthy volunteers
  • Child

To be eligible for the study, a child must meet the following criteria since enrollment in the CEP 302 Trial:

  1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria
  2. Time since diagnosis of at least six months
  3. Age between 2.00 and 6.99 years at enrollment
  4. Parental consent to participate in the study
  5. Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302 Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor.

To be eligible for the study, a parent must meet the following criteria:

  1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above.
  2. Age of 18.0 years or older.
  3. Parent comprehends written English.
  4. Parent understands the study protocol and signs the informed consent document.

The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial):

  1. 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).
  2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
  3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  4. Child is unable to completely avoid acetaminophen for duration of study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).

Being tested
Developmental & Technological Demands, Distress Reduction, Nutrition, Set Point, & C:I Ratio, Hypoglycemia management, Minimal Intervention
Keywords
670G, Hybrid closed-loop system, pediatric
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.

  • Developmental & Technological DemandsBehavioural

    Education and training related to use of CGM in this age group

  • Distress ReductionBehavioural

    Education and training on reducing distress

  • Nutrition, Set Point, & C:I RatioBehavioural

    Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control

  • Hypoglycemia managementBehavioural

    Education and training on reducing worries of hypoglycemia

  • Minimal InterventionBehavioural

    Minimal intervention to simulate standard care - serves as the control group

Study groups in NCT03354286
Study groupRoleWhat they receive
Developmental & Technological DemandsExperimentalProvide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. Identify and troubleshoot barriers to keeping young children in Auto Mode.
Receives: Behavioral: Developmental & Technological Demands
Distress ReductionExperimentalIdentify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Receives: Behavioral: Distress Reduction
Nutrition, Set Point, & C:I RatioExperimentalProvide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control.
Receives: Behavioral: Nutrition, Set Point, & C:I Ratio
Hypoglycemia managementExperimentalFocus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
Receives: Behavioral: Hypoglycemia management
Minimal InterventionPlacebo comparatorA short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
Receives: Behavioral: Minimal Intervention

What is being measured

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

  1. Time spent in blood glucose range

    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.

    Measured: Change over 3 months

Secondary outcomes (13)

  1. 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: Change over 3 months

  2. Problem Areas in Diabetes

    This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.

    Measured: Change over 3 months

  3. Parent Diabetes Distress Scale

    This measure is widely used to capture the psychological distress experienced in relation to diabetes.

    Measured: Change over 3 months

  4. Patient Health Questionnaire 8

    This is a widely used measure that captures depressive symptoms. It is reported by the participants.

    Measured: Change over 3 months

  5. State-Trait Anxiety Inventory

    This is a widely used measure of anxiety symptoms. It is reported by the participant.

    Measured: Change over 3 months

  6. Pittsburgh Sleep Quality Index

    This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.

    Measured: Change over 3 months

  7. Hypoglycemic Fear Survey - Parents

    People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.

    Measured: Change over 3 months

  8. Hypoglycemia Confidence Questionnaire

    Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.

    Measured: Change over 3 months

  9. 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.

    Measured: Change over 3 months

  10. Glucose Monitoring System Satisfaction Survey

    This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.

    Measured: Change over 3 months

  11. General and diabetes-specific technology use

    This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.

    Measured: Change over 3 months

  12. Diabetes management behaviors

    Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads.

    Measured: Change over 3 months

  13. Health care utilization

    Number of visits and calls to the diabetes care team.

    Measured: Change over 3 months

Timeline

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

  1. First posted27 Nov 2017
  2. Study start7 Nov 2017
  3. Primary completion18 Mar 2019
  4. Study completion18 Mar 2019

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
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354286
Sponsor's protocol ID
43167
Status last verified
Sep 2019
First submitted
21 Nov 2017
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Developmental & Technological Demands, Distress Reduction and Nutrition, Set Point, & C:I Ratio in people with Type 1 Diabetes Mellitus, run by Stanford University 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: finished, as of the sponsor's last update on 25 Sep 2019. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Change over 3 months). 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 NCT03354286.

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 25 Sep 2019.

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