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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CGM + Family Behavioral Intervention

Standard CGM

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator
Age 2-<8 years at consent
Diabetes duration ≥ 6 months
Total daily insulin ≥ 0.3 units per kg per day
HbA1c 7.0% to <10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility)
No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
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).
Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in
Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study
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).
Parent understands the study protocol and agrees to it
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:

Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
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
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.
More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx).
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)
Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver
Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
Participation of parent or child in a diabetes related intervention study in past 6 weeks.
Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention
Another member of the same household is participating in this study.

Sites / Locations

Indiana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

CGM + Family Behavioral Intervention

Standard CGM

BGM - usual care control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time in glucose range 70-180

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

HbA1c at 6-months

A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.

% HbA1c <7.0%

% HbA1c <7.5%

% with relative reduction in HbA1c >=10%

% with absolute reduction in HbA1c >=0.5%

% with absolute reduction in HbA1c >=1%

% with absolute reduction in HbA1c >=1% or HbA1c <7.0%

Mean glucose

Glucose variability measured by coefficient of variation

% time >180 mg/dl

% time >250 mg/dl

% time >300 mg/dl

Area under the curve 180 mg/dl

High blood glucose index (HBGI)

% time <54 mg/dl

% time <60 mg/dl

% time <70 mg/dl

Area over the curve 70 mg/dl

Low blood glucose index (LBGI)

Hypoglycemic events (using <54 mg/dl)

WHO-5 Well Being Index

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.

Hypoglycemia Fear Survey Total Score

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.

Hypoglycemia Fear Survey Worry Subscale

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.

Diabetes Technology Questionnaire

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.

Problem Areas in Diabetes - Parent (PAID-PR)

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.

Diabetes Family Impact Survey

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.

Satisfaction Questionnaire

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.

Full Information

NCT ID

NCT02912728

First Posted

September 20, 2016

Last Updated

October 2, 2020

Sponsor

Jaeb Center for Health Research

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust, Indiana University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02912728

Brief Title

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

Acronym

SENCE

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 30, 2017 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jaeb Center for Health Research

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust, Indiana University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CGM + Family Behavioral Intervention

Arm Type

Active Comparator

Arm Description

Arm Title

Standard CGM

Arm Type

Active Comparator

Arm Description

Arm Title

BGM - usual care control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

CGM + Family Behavioral Intervention

Other Intervention Name(s)

FBI

Intervention Description

use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence

Intervention Type

Device

Intervention Name(s)

Standard CGM

Intervention Description

use of CGM alone to assess CGM adherence

Primary Outcome Measure Information:

Title

Time in glucose range 70-180

Description

Time Frame

Up to 26 weeks

Secondary Outcome Measure Information:

Title

HbA1c at 6-months

Description

A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.

Time Frame

6 Months

Title

% HbA1c <7.0%

Time Frame

6 Months

Title

% HbA1c <7.5%

Time Frame

6 Months

Title

% with relative reduction in HbA1c >=10%

Time Frame

6 Months

Title

% with absolute reduction in HbA1c >=0.5%

Time Frame

6 Months

Title

% with absolute reduction in HbA1c >=1%

Time Frame

6 Months

Title

% with absolute reduction in HbA1c >=1% or HbA1c <7.0%

Time Frame

6 Months

Title

Mean glucose

Time Frame

6 Months

Title

Glucose variability measured by coefficient of variation

Time Frame

6 Months

Title

% time >180 mg/dl

Time Frame

6 Months

Title

% time >250 mg/dl

Time Frame

6 Months

Title

% time >300 mg/dl

Time Frame

6 Months

Title

Area under the curve 180 mg/dl

Time Frame

6 Months

Title

High blood glucose index (HBGI)

Time Frame

6 Months

Title

% time <54 mg/dl

Time Frame

6 Months

Title

% time <60 mg/dl

Time Frame

6 Months

Title

% time <70 mg/dl

Time Frame

6 Months

Title

Area over the curve 70 mg/dl

Time Frame

6 Months

Title

Low blood glucose index (LBGI)

Time Frame

6 Months

Title

Hypoglycemic events (using <54 mg/dl)

Time Frame

6 Months

Title

WHO-5 Well Being Index

Description

Time Frame

6 Months

Title

Hypoglycemia Fear Survey Total Score

Description

Time Frame

6 Months

Title

Hypoglycemia Fear Survey Worry Subscale

Description

Time Frame

6 Months

Title

Diabetes Technology Questionnaire

Description

Time Frame

6 Months

Title

Problem Areas in Diabetes - Parent (PAID-PR)

Description

Time Frame

6 Months

Title

Diabetes Family Impact Survey

Description

Time Frame

6 Months

Title

Satisfaction Questionnaire

Description

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator Age 2-<8 years at consent Diabetes duration ≥ 6 months Total daily insulin ≥ 0.3 units per kg per day HbA1c 7.0% to <10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility) No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days 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). Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study 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). Parent understands the study protocol and agrees to it 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: Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days 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 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. More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx). 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) Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial Participation of parent or child in a diabetes related intervention study in past 6 weeks. Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention Another member of the same household is participating in this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda DiMeglio, MD, MPH

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

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Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):464-472. doi: 10.2337/dc20-1060. Epub 2020 Dec 17.

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

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