Type 1 Diabetes MellitusSENCENCT02912728
Strategies to Enhance New CGM Use in Early Childhood (SENCE)
A study testing CGM + Family Behavioral Intervention and Standard CGM in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CGM + Family Behavioral Intervention and Standard CGM
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Type 1 Diabetes Mellitus
- Being tested
- CGM + Family Behavioral Intervention, Standard CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM + Family Behavioral InterventionBehavioural
Also called FBI
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
Standard CGMDevice
use of CGM alone to assess CGM adherence
| Study group | Role | What they receive |
|---|---|---|
| CGM + Family Behavioral Intervention | Active comparator | 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. Receives: Behavioral: CGM + Family Behavioral Intervention |
| Standard CGM | Active comparator | 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. Receives: Device: Standard CGM |
| BGM - usual care control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 26 weeks
Secondary outcomes (21)
HbA1c at 6-months
A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.
Measured: 6 Months
% HbA1c <7.0%
Measured: 6 Months
% HbA1c <7.5%
Measured: 6 Months
% With Relative Reduction in HbA1c >=10%
Measured: 6 Months
% With Absolute Reduction in HbA1c >=0.5%
Measured: 6 Months
% With Absolute Reduction in HbA1c >=1%
Measured: 6 Months
% With Absolute Reduction in HbA1c >=1% or HbA1c <7.0%
Measured: 6 Months
Mean Glucose
Measured: 6 Months
Glucose Variability Measured by Coefficient of Variation
Measured: 6 Months
% Time >180 mg/dl
Measured: 6 Months
% Time >250 mg/dl
Measured: 6 Months
% Time >300 mg/dl
Measured: 6 Months
% Time <54 mg/dl
Measured: 6 Months
% Time <60 mg/dl
Measured: 6 Months
% Time <70 mg/dl
Measured: 6 Months
Hypoglycemic Events (Using <54 mg/dl)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start30 Jan 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Indiana University
- Responsible party
- Sponsor
- Investigators
- Linda DiMeglio, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912728
- Sponsor's protocol ID
- T1DX SENCE
- Acronym
- SENCE
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2016
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 22210571Sundberg 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 23809540Rovet 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 10190928Rovet 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 3342715Ryan 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 19067890Barnea-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 24319123Marzelli 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 24170697Wood 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 23340893Tsalikian 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 22151826Topp 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 25831962Markowitz 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 21883443Katz 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 25655562Cox 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 3677982Wysocki 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02912728
- Acronym / sponsor ID
- SENCE / T1DX SENCE
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Indiana University
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Posted 16 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CGM + Family Behavioral Intervention | Active comparator | Behavioral: CGM + Family Behavioral InterventionCGM 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. |
| Standard CGM | Active comparator | Device: Standard CGMEach 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. |
| BGM - usual care control group | No intervention | –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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM + Family Behavioral InterventionAlso: FBIuse of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence | Behavioural | CGM + Family Behavioral Intervention |
| Standard CGMuse of CGM alone to assess CGM adherence | Device | Standard CGM |
Primary outcome
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.
21 secondary outcomes
HbA1c at 6-months
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
Time frame: 6 Months
Hypoglycemia Fear Survey Total Score
Time frame: 6 Months
Hypoglycemia Fear Survey Worry Subscale
Time frame: 6 Months
Problem Areas in Diabetes - Parent (PAID-PR)
Time frame: 6 Months
Diabetes Family Impact Survey
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22210571Mauras 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.
- Background: PubMed 23809540Sundberg 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.
- Background: PubMed 10190928Rovet 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.
- Background: PubMed 3342715Rovet 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.
- Background: PubMed 19067890Ryan 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.
- Background: PubMed 24319123Barnea-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.
- Background: PubMed 24170697Marzelli 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.
- Background: PubMed 23340893Wood 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.
- Background: PubMed 22151826Tsalikian 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.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 21883443Markowitz 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.
- Background: PubMed 25655562Katz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda DiMeglio, MD, MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM + Family Behavioral Intervention and Standard CGM in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Glucose Range 70-180 (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912728, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.