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

Jaeb Center for Health Research

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Standard CGM; Behavioral: CGM + Family Behavioral Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02912728

T1DX SENCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

143 participants in 3 patient groups

CGM + Family Behavioral Intervention

Active Comparator group

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.

Treatment:

Behavioral: CGM + Family Behavioral Intervention

Standard CGM

Active Comparator group

Description:

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.

Treatment:

Device: Standard CGM

BGM - usual care control group

No Intervention group

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.