CompletedNCT02912728SENCEUpdated Sep 16, 2026Results posted

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

An interventional study of CGM + Family Behavioral Intervention and Standard CGM in Type 1 Diabetes Mellitus, sponsored by Jaeb Center for Health Research. Completed at 1 site in United States. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Jaeb Center for Health Research · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 143
Allocation: Randomized
Ages: 2 Years to 7 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Type 1 Diabetes Mellitus

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Diabetes Mellitus, Type 1 3,522

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 143 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 7 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 143 participants (actual)

Study arms

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
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
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.

Interventions

BehavioralCGM + Family Behavioral Intervention
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
Also known as: FBI
DeviceStandard CGM
use of CGM alone to assess CGM adherence

What researchers measure

Primary outcomes

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.
Time frame: Up to 26 weeks

Secondary outcomes

HbA1c at 6-months
A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.
Time frame: 6 Months
% HbA1c <7.0%
Time frame: 6 Months
% HbA1c <7.5%
Time frame: 6 Months
% With Relative Reduction in HbA1c >=10%
Time frame: 6 Months
% With Absolute Reduction in HbA1c >=0.5%
Time frame: 6 Months
% With Absolute Reduction in HbA1c >=1%
Time frame: 6 Months
% With Absolute Reduction in HbA1c >=1% or HbA1c <7.0%
Time frame: 6 Months
Mean Glucose
Time frame: 6 Months
Glucose Variability Measured by Coefficient of Variation
Time frame: 6 Months
% Time >180 mg/dl
Time frame: 6 Months
% Time >250 mg/dl
Time frame: 6 Months
% Time >300 mg/dl
Time frame: 6 Months
% Time <54 mg/dl
Time frame: 6 Months
% Time <60 mg/dl
Time frame: 6 Months
% Time <70 mg/dl
Time frame: 6 Months
Hypoglycemic Events (Using <54 mg/dl)
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: 6 Months
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.
Time frame: 6 Months

Results

Posted Sep 16, 2026

Participant flow

Participant flow — Overall Study
Milestone	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Started	50	44	49
Completed	50	44	49
Not completed	0	0	0

Outcome measures

PrimaryTime 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.

Time frame:: Up to 26 weeks
Reported as:: Mean · percent

Time in Glucose Range 70-180
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Time in Glucose Range 70-180	42 ± 10	41 ± 9	40 ± 9

SecondaryHbA1c at 6-months

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

Time frame:: 6 Months
Reported as:: Mean · percentage of glycosylated hemoglobin

HbA1c at 6-months
percentage of glycosylated hemoglobin	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
HbA1c at 6-months	8.1 ± 0.9	8.2 ± 0.8	8.1 ± 0.8

Secondary% HbA1c <7.0%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% HbA1c <7.0%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% HbA1c <7.0%	5	3	3

Secondary% HbA1c <7.5%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% HbA1c <7.5%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% HbA1c <7.5%	14	7	13

Secondary% With Relative Reduction in HbA1c >=10%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% With Relative Reduction in HbA1c >=10%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% With Relative Reduction in HbA1c >=10%	6	6	3

Secondary% With Absolute Reduction in HbA1c >=0.5%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% With Absolute Reduction in HbA1c >=0.5%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% With Absolute Reduction in HbA1c >=0.5%	18	12	12

Secondary% With Absolute Reduction in HbA1c >=1%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% With Absolute Reduction in HbA1c >=1%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% With Absolute Reduction in HbA1c >=1%	5	5	3

Secondary% With Absolute Reduction in HbA1c >=1% or HbA1c <7.0%

Time frame:: 6 Months
Reported as:: Count of participants · Participants

% With Absolute Reduction in HbA1c >=1% or HbA1c <7.0%
Participants	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% With Absolute Reduction in HbA1c >=1% or HbA1c <7.0%	7	8	5

SecondaryMean Glucose

Time frame:: 6 Months
Reported as:: Mean · mg/dL

Mean Glucose
mg/dL	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Mean Glucose	205 ± 22	205 ± 22	201 ± 24

SecondaryGlucose Variability Measured by Coefficient of Variation

Time frame:: 6 Months
Reported as:: Mean · percent

Glucose Variability Measured by Coefficient of Variation
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Glucose Variability Measured by Coefficient of Variation	41 ± 5	40 ± 5	45 ± 6

Secondary% Time >180 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time >180 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time >180 mg/dl	55 ± 10	57 ± 10	54 ± 10

Secondary% Time >250 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time >250 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time >250 mg/dl	29 ± 11	28 ± 10	29 ± 10

Secondary% Time >300 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time >300 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time >300 mg/dl	16 ± 8	14 ± 8	17 ± 8

Secondary% Time <54 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time <54 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time <54 mg/dl	0.7 ± 0.7	0.7 ± 0.7	2.4 ± 1.7

Secondary% Time <60 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time <60 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time <60 mg/dl	1.2 ± 1.0	1.2 ± 1.0	3.5 ± 2.3

Secondary% Time <70 mg/dl

Time frame:: 6 Months
Reported as:: Mean · percent

% Time <70 mg/dl
percent	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
% Time <70 mg/dl	2.6 ± 1.6	2.5 ± 1.9	5.8 ± 3.3

SecondaryHypoglycemic Events (Using <54 mg/dl)

Time frame:: 6 Months
Reported as:: Median · events

Hypoglycemic Events (Using <54 mg/dl)
events	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Hypoglycemic Events (Using <54 mg/dl)	1.0 (0.3 to 1.7)	1.0 (0.6 to 1.4)	2.7 (1.5 to 3.9)

SecondaryWHO-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.

Time frame:: 6 Months
Reported as:: Mean · units on a scale

WHO-5 Well Being Index
units on a scale	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
WHO-5 Well Being Index	66 ± 18	65 ± 15	63 ± 16

SecondaryHypoglycemia 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.

Time frame:: 6 Months
Reported as:: Mean · units on a scale

Hypoglycemia Fear Survey Total Score
units on a scale	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Hypoglycemia Fear Survey Total Score	35 ± 15	44 ± 16	46 ± 16

SecondaryHypoglycemia 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.

Time frame:: 6 Months
Reported as:: Mean · units on a scale

Hypoglycemia Fear Survey Worry Subscale
units on a scale	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Hypoglycemia Fear Survey Worry Subscale	31 ± 20	41 ± 21	43 ± 20

SecondaryProblem 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.

Time frame:: 6 Months
Reported as:: Mean · units on a scale

Problem Areas in Diabetes - Parent (PAID-PR)
units on a scale	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Problem Areas in Diabetes - Parent (PAID-PR)	40 ± 19	52 ± 16	51 ± 16

SecondaryDiabetes 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.

Time frame:: 6 Months
Reported as:: Mean · units on a scale

Diabetes Family Impact Survey
units on a scale	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Diabetes Family Impact Survey	21 ± 16	24 ± 15	27 ± 19

Adverse events

Collected over From enrollment until end of follow-up, up to 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CGM + Family Behavioral Intervention	0/50 (0%)	2/50 (4%)	3/50 (6%)
Standard CGM	0/44 (0%)	3/44 (6.8%)	7/44 (15.9%)
BGM - Usual Care Control Group	0/49 (0%)	5/49 (10.2%)	6/49 (12.2%)

Most frequent serious events

Most frequent serious events
Event	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Severe hypoglycemiaEndocrine disorders	0/50	0/44	5/49
Diabetic ketoacidosisEndocrine disorders	0/50	1/44	0/49
Urinary tract infectionRenal and urinary disorders	0/50	1/44	0/49
KetosisMetabolism and nutrition disorders	0/50	1/44	0/49
AppendicitisGeneral disorders	1/50	0/44	0/49
LipoatrophySkin and subcutaneous tissue disorders	1/50	0/44	0/49

Most frequent other events

Most frequent other events
Event	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group
Endocrine disordersEndocrine disorders	1/50	2/44	4/49
Metabolism and nutrition disordersMetabolism and nutrition disorders	0/50	3/44	1/49
Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications	0/50	2/44	0/49
Renal and urinary disordersRenal and urinary disorders	0/50	1/44	0/49
Nervous system disordersNervous system disorders	0/50	0/44	1/49
Gastrointestinal disordersGastrointestinal disorders	1/50	0/44	0/49
Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders	1/50	0/44	0/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group	Total
Mean	6 ± 2	5 ± 2	6 ± 2	6 ± 2

Sex: Female, Male
Sex: Female, Male(Participants)	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group	Total
Female	29	17	26	72
Male	21	27	23	71

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group	Total
Non-Hispanic White	32	33	30	95
Non-Hispanic Black	10	4	7	21
Hispanic or Latino	5	5	6	16
Asian	0	0	1	1
More than one race	2	1	4	7

Highest Parent Education
Highest Parent Education(Participants)	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group	Total
High School or Less	13	10	9	32
Some college/Associate degree	13	14	20	47
Bachelor degree or higher	21	16	20	57

Annual Household Income
Annual Household Income(Participants)	CGM + Family Behavioral Intervention	Standard CGM	BGM - Usual Care Control Group	Total
<$35,000	9	11	5	25
$35,000-<$75,000	19	19	16	54
≥$75,000	18	12	22	52

Study locations

1 site

Indiana
Indianapolis, Indiana 46202, United States

References and documents

Publications

Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30. PubMed 22210571 ↗
Sundberg F, Forsander G. Detection and treatment efficacy of hypoglycemic events in the everyday life of children younger than 7 yr. Pediatr Diabetes. 2014 Feb;15(1):34-40. doi: 10.1111/pedi.12057. Epub 2013 Jun 27. PubMed 23809540 ↗
Rovet JF, Ehrlich RM. The effect of hypoglycemic seizures on cognitive function in children with diabetes: a 7-year prospective study. J Pediatr. 1999 Apr;134(4):503-6. doi: 10.1016/s0022-3476(99)70211-8. PubMed 10190928 ↗
Rovet JF, Ehrlich RM, Hoppe M. Specific intellectual deficits in children with early onset diabetes mellitus. Child Dev. 1988 Feb;59(1):226-34. doi: 10.1111/j.1467-8624.1988.tb03211.x. PubMed 3342715 ↗
Ryan CM. Searching for the origin of brain dysfunction in diabetic children: going back to the beginning. Pediatr Diabetes. 2008 Dec;9(6):527-30. doi: 10.1111/j.1399-5448.2008.00481.x. No abstract available. PubMed 19067890 ↗
Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6. PubMed 24319123 ↗
Marzelli MJ, Mazaika PK, Barnea-Goraly N, Hershey T, Tsalikian E, Tamborlane W, Mauras N, White NH, Buckingham B, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Neuroanatomical correlates of dysglycemia in young children with type 1 diabetes. Diabetes. 2014 Jan;63(1):343-53. doi: 10.2337/db13-0179. Epub 2013 Oct 29. PubMed 24170697 ↗
Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22. PubMed 23340893 ↗
Tsalikian E, Fox L, Weinzimer S, Buckingham B, White NH, Beck R, Kollman C, Xing D, Ruedy K; Diabetes Research in Children Network Study Group. Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes. Pediatr Diabetes. 2012 Jun;13(4):301-7. doi: 10.1111/j.1399-5448.2011.00837.x. Epub 2011 Dec 13. PubMed 22151826 ↗
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. PubMed 25831962 ↗
Markowitz JT, Volkening LK, Butler DA, Antisdel-Lomaglio J, Anderson BJ, Laffel LM. Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR). Diabet Med. 2012 Apr;29(4):526-30. doi: 10.1111/j.1464-5491.2011.03434.x. PubMed 21883443 ↗
Katz ML, Volkening LK, Dougher CE, Laffel LM. Validation of the Diabetes Family Impact Scale: a new measure of diabetes-specific family impact. Diabet Med. 2015 Sep;32(9):1227-31. doi: 10.1111/dme.12689. Epub 2015 Feb 5. PubMed 25655562 ↗
Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987 Sep-Oct;10(5):617-21. doi: 10.2337/diacare.10.5.617. PubMed 3677982 ↗
Wysocki T, Reeves G, Kummer M, Ross J, Yu M. Psychometric validations of the Diabetes Technology Questionnaire; Diabetes. 2015;64(Suppl1): A633.
Bilionis I, Berrios RC, de Arriba Munoz A, Fernandez-Luque L, Castillo C. A framework for assessing algorithmic discrimination risks in training data: a case of pediatric type 1 diabetes. JAMIA Open. 2026 Jul 14;9(4):ooag125. doi: 10.1093/jamiaopen/ooag125. eCollection 2026 Aug. PubMed 42459945 ↗
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. PubMed 33334807 ↗
DiMeglio LA, Kanapka LG, DeSalvo DJ, Anderson BJ, Harrington KR, Hilliard ME, Laffel LM, Tamborlane WV, Van Name MA, Wadwa RP, Willi SM, Woerner S, Wong JC, Miller KM; SENCE Study Group. Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study. Diabet Med. 2020 Aug;37(8):1308-1315. doi: 10.1111/dme.14276. Epub 2020 Mar 17. PubMed 32096282 ↗

Study documents

Study protocol · Aug 8, 2017
Statistical analysis plan · Apr 8, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02912728
Lead sponsor: Jaeb Center for Health Research
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Indiana University
Responsible party: Sponsor
First posted: Sep 23, 2016
Start date: Jan 30, 2017
Primary completion: Jun 30, 2019
Completion: Jun 30, 2019
Results posted: Sep 16, 2026
Last update: Sep 16, 2026

Study contacts

Linda DiMeglio, MD, MPH

principal investigator · Indiana University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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