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Strategies to Enhance New CGM Use in Early Childhood (SENCE) (SENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912728
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
Indiana University School of Medicine
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
The primary objective of this study is to compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: CGM + Family Behavioral Intervention Device: Standard CGM Not Applicable

Detailed Description:
Although prior studies have not demonstrated that continuous glucose monitoring (CGM) use results in improved glycemic control in children <8 years of age, many of the barriers to CGM efficacy in this age group may have been due to problems in the wearability and accuracy of prior generation devices, as well as to the setting of glycemic targets aimed primarily at preventing hypoglycemia at all costs. There may also be behavioral barriers to consistent and effective CGM use in this age range. The goal of this study is to assess the impact of CGM alone and CGM combined with a family behavioral intervention focused on supporting CGM use on glycemic control in very young children with T1D compared with usual care without CGM.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Strategies to Enhance New CGM Use in Early Childhood: A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Youth < 8 With Type 1 Diabetes
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: CGM + Family Behavioral Intervention
CGM training for CGM groups using a standard curriculum will take place at the 1, 3 and 6 week visits in addition to the training at baseline. The family behavioral intervention will be delivered by a study coordinator (separate coordinator from the CGM instruction) at the 1, 3, 6, 13 and 19 week visits and is expected to take approximately 30 minutes.
Behavioral: CGM + Family Behavioral Intervention
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
Other Name: FBI

Active Comparator: Standard CGM

Each participant will be asked to use a CGM sensor on a daily basis, inserting a new sensor as needed with a maximum of 7 days of wear per sensor.

A home BGM will be used for calibration of the CGM sensor. Additional BGM glucose measurements may be performed by the participant at any time, particularly prior to making a real-time management decision based on the CGM glucose reading.

Participants will be instructed to use the CGM as per the FDA labeling.

Device: Standard CGM
use of CGM alone to assess CGM adherence

No Intervention: BGM - usual care control group
A BGM will be used for a finger stick blood glucose check with a recommendation of at least 4 times a day. BGM data will be downloaded and reviewed with the participant at each visit.



Primary Outcome Measures :
  1. Time in glucose range 70-180 [ Time Frame: Up to 26 weeks ]
    The primary outcome will be three 2 group comparisons of the change from baseline in the percentage of sensor values in the target range (70-180 mg/dL), in an ANCOVA model adjusted for the baseline value and factors used to stratify randomization with clinical site as a random effect. Seven days of sensor glucose values during the week prior to the 6, 13, 19 and 26 week clinic visits will be used in analysis for the CGM groups to match up with the blinded CGM placed at each visit in the control group. The CGM data will be pooled across each visit where CGM data are collected during follow up for the primary analysis.


Secondary Outcome Measures :
  1. HbA1c at 6-months [ Time Frame: 6 Months ]
    A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.

  2. % HbA1c <7.0% [ Time Frame: 6 Months ]
  3. % HbA1c <7.5% [ Time Frame: 6 Months ]
  4. % with relative reduction in HbA1c >=10% [ Time Frame: 6 Months ]
  5. % with absolute reduction in HbA1c >=0.5% [ Time Frame: 6 Months ]
  6. % with absolute reduction in HbA1c >=1% [ Time Frame: 6 Months ]
  7. % with absolute reduction in HbA1c >=1% or HbA1c <7.0% [ Time Frame: 6 Months ]
  8. Mean glucose [ Time Frame: 6 Months ]
  9. Glucose variability measured by coefficient of variation [ Time Frame: 6 Months ]
  10. % time >180 mg/dl [ Time Frame: 6 Months ]
  11. % time >250 mg/dl [ Time Frame: 6 Months ]
  12. % time >300 mg/dl [ Time Frame: 6 Months ]
  13. Area under the curve 180 mg/dl [ Time Frame: 6 Months ]
  14. High blood glucose index (HBGI) [ Time Frame: 6 Months ]
  15. % time <54 mg/dl [ Time Frame: 6 Months ]
  16. % time <60 mg/dl [ Time Frame: 6 Months ]
  17. % time <70 mg/dl [ Time Frame: 6 Months ]
  18. Area over the curve 70 mg/dl [ Time Frame: 6 Months ]
  19. Low blood glucose index (LBGI) [ Time Frame: 6 Months ]
  20. Hypoglycemic events (using <54 mg/dl) [ Time Frame: 6 Months ]
  21. WHO-5 Well Being Index [ Time Frame: 6 Months ]
    Survey containing 5 questions with possible responses 0-5. The raw score is calculated by summing the responses. The raw score ranges from 0-25. A percentage score ranging from 0 to 100 is obtained by multiplying the raw score by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.

  22. Hypoglycemia Fear Survey Total Score [ Time Frame: 6 Months ]
    Survey containing 26 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear.

  23. Hypoglycemia Fear Survey Worry Subscale [ Time Frame: 6 Months ]
    Survey containing 26 questions with possible responses 0-4. Worry subscale score is calculated by taking the mean of the non-missing responses to questions 11-26 and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear.

  24. Diabetes Technology Questionnaire [ Time Frame: 6 Months ]
    Survey containing 30 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 100 to put on the scale 0-100. A higher total score indicates less of a problem.

  25. Problem Areas in Diabetes - Parent (PAID-PR) [ Time Frame: 6 Months ]
    Survey containing 18 questions with possible responses 0-4. Total score is calculated by reverse scoring each item, then taking the mean of the non-missing responses. The score is then multiplied by 25 to put on the scale 0-100. A higher total score indicates more burden.

  26. Diabetes Family Impact Survey [ Time Frame: 6 Months ]
    Survey containing 15 questions with possible responses 0-3. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 3 to put on the scale 0-100. A higher total score indicates more negative impact.

  27. Satisfaction Questionnaire [ Time Frame: 6 Months ]
    Section 2 of the satisfaction questionnaire contains 8 questions for the CGM groups only with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher total score indicates more satisfaction with the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator
  2. Age 2-<8 years at consent
  3. Diabetes duration ≥ 6 months
  4. Total daily insulin ≥ 0.3 units per kg per day
  5. HbA1c 7.0% to <10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility)
  6. No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
  7. Insulin regimen involves either use of a consistent insulin regimen with an insulin pump in the last 3 months or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin in the last 3 months (e.g. no change from injections to pump or vice versa in the last 3 months), with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections).
  8. Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in
  9. Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study
  10. Parent or guardian comprehend written and spoken English (This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages, and interventions will be delivered in English only for the RCT to ensure standardization/fidelity checks across sites).
  11. Parent understands the study protocol and agrees to it
  12. No expectation that participant/parent will be moving out of the area of the clinical center during the next 12 months, unless the move will be to an area served by another study center.

Exclusion Criteria:

  1. Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
  2. Unable to use CGM device for minimum number of hours during blinded run-in period or skin reaction from adhesive that would preclude participation in the randomized trial
  3. The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  4. More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx).
  5. The presence of any of the following diseases:

    • Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
    • Cystic fibrosis (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
  6. Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver
  7. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
  8. Participation of parent or child in a diabetes related intervention study in past 6 weeks.
  9. Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention
  10. Another member of the same household is participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912728


Locations
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United States, Indiana
Indiana
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Jaeb Center for Health Research
The Leona M. and Harry B. Helmsley Charitable Trust
Indiana University School of Medicine
Investigators
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Principal Investigator: Linda DiMeglio, MD, MPH Indiana University School of Medicine
Publications:
Wysocki T, Reeves G, Kummer M, Ross J, Yu M. Psychometric validations of the Diabetes Technology Questionnaire; Diabetes. 2015;64(Suppl1): A633.

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02912728    
Other Study ID Numbers: T1DX SENCE
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases