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Completed

NCT Number: NCT04696640

Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes

This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months
  • Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months
  • Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic.

Exclusion criteria

  • Patient's CGM cannot be uploaded to Glooko

Treatment and study plan

Remote Patient Monitoring

Behavioral

Participants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic).

Primary outcomes

  1. Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health

    Time frame: 1 month baseline period

    Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.

  2. Change in hemoglobin A1c (HbA1c)

    Time frame: Initiation = 1 month after enrollment, Study completion = 7 months after enrollment

    HbA1c at study completion minus the HbA1c at initiation

Secondary outcomes

  1. Data-sharing experience survey

    Time frame: 1 month after enrollment

    Survey asking about patient's experience with data-sharing

  2. Target Glucose Range

    Time frame: Months 1-7 after enrollment

    Percentage of time spent in target glucose range (generated from continuous glucose monitor)

  3. Hyperglycemic range

    Time frame: Months 1-7 after enrollment

    Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)

  4. Hypoglycemic range

    Time frame: Months 1-7 after enrollment

    Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)

  5. Overall continuous glucose monitor (CGM) wear time

    Time frame: Months 1-7 after enrollment

    Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)

  6. Remote patient monitoring survey

    Time frame: Month 7 after enrollment

    Survey asking about patient's experience with remote patient monitoring

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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