Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

NCT02734667 | Completed Results DMC

• 1 other identifier: 35990
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

  Baseline, 24 months

• Time Spent in Hypoglycemia (< 70 mg/dL)

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

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

Secondary Outcomes (13)

• Pediatric Quality of Life Inventory

  Baseline, 24 months

• Problem Areas in Diabetes Score

  Baseline, 24 months

• Diabetes Distress Scale

  Baseline, 24 months

• Patient Health Questionnaire 9

  Baseline, 24 months

• State-Trait Anxiety Inventory

  Baseline, 24 months

Study Arms (2)

CGM at diagnosis of T1D

EXPERIMENTAL

Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.

Device: CGM at diagnosis of T1D

Usual Care

NO INTERVENTION

Participants receive usual care for T1D for 6 months post diagnosis.

Interventions

CGM at diagnosis of T1D DEVICE

Initiation of non-adjunctive CGM use at diagnosis of T1D

CGM at diagnosis of T1D

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korey Hood: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Primary and secondary survey outcome data is limited to participants with complete records.

Results Point of Contact

• Title: Dr. Korey Hood
• Organization: Stanford University

kkhood@stanford.edu

6504976899

Study Officials

• Korey K Hood, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Paul Wadwa, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 2, 2022
• Results First Posted: August 17, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)