Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
7 november 2019 uppdaterad av: Korey Hood, Stanford University
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
92
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
California
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Stanford, California, Förenta staterna, 94305
- Stanford University
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado
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Florida
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Tampa, Florida, Förenta staterna, 33620
- University of South Florida
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 år till 6 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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 at least six months
- Age between 2 and 6 years at enrollment
- Parental consent 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.
- If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
- Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod
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
- Parent has access to a personal computer to upload diabetes devices and send to research team
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Distress Reduction
Identifiera och minska föräldrars nödsymptom och oro.
Ge strategier för att få socialt stöd.
|
Utbildning och träning om att minska nöd
|
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Experimentell: Developmental Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
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Education and training related to use of CGM in this age group
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Experimentell: Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
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Education and training on the use of remote monitoring
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Experimentell: Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
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Education and training on reducing fear of hypoglycemia
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Placebo-jämförare: No Intervention
Serves as the control group comparator.
No intervention provided.
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No intervention - serves as the control group
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time spent in blood glucose range
Tidsram: Change over 6 months
|
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.
|
Change over 6 months
|
|
Pediatric Quality of Life Inventory
Tidsram: Change over 6 months
|
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.
|
Change over 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
A1c
Tidsram: Change over 6 months
|
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.
|
Change over 6 months
|
|
Problem Areas in Diabetes
Tidsram: Change over 6 months
|
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.
|
Change over 6 months
|
|
Diabetes Distress Scale
Tidsram: Change over 6 months
|
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
|
Change over 6 months
|
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Patient Health Questionnaire 9
Tidsram: Change over 6 months
|
This is a widely used measure that captures depressive symptoms.
It is reported by the participants.
|
Change over 6 months
|
|
State-Trait Anxiety Inventory
Tidsram: Change over 6 months
|
This is a widely used measure of anxiety symptoms.
It is reported by the participant.
|
Change over 6 months
|
|
Pittsburgh Sleep Quality Index
Tidsram: Change over 6 months
|
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
|
Change over 6 months
|
|
Hypoglycemic Fear Survey
Tidsram: Change over 6 months
|
People with diabetes worry about hypoglycemia.
This measure captures those worries and is reported by participants.
|
Change over 6 months
|
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Hypoglycemic Confidence Questionnaire
Tidsram: Change over 6 months
|
Hypoglycemia needs to be managed in various daily situations.
This questionnaire captures confidence of the participants in those various situations.
|
Change over 6 months
|
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Glucose Monitoring System Satisfaction Survey
Tidsram: Change over 6 months
|
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
|
Change over 6 months
|
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General and diabetes-specific technology use
Tidsram: Change over 6 months
|
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
|
Change over 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Linda DiMeglio, MD, Indiana University
- Huvudutredare: Kimberly Driscoll, PhD, University of Colorado, Denver
- Huvudutredare: Henry Rodriguez, MD, University of South Florida
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 augusti 2016
Primärt slutförande (Faktisk)
1 april 2019
Avslutad studie (Faktisk)
1 april 2019
Studieregistreringsdatum
Först inskickad
25 juli 2016
Först inskickad som uppfyllde QC-kriterierna
25 juli 2016
Första postat (Uppskatta)
28 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 37360
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
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