Type1diabetesNCT04614623
Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D
A study testing AHCL pump and Video conferencing Application in people with Type1diabetes, run by Children's Hospital New Orleans, LA at 1 site in United States.
Trial summary
Type 1 diabetes (T1D), is associated with considerable risk of morbidity and mortality due to chronic hyperglycemia. Despite innovations in management, pediatric patients of African ancestry (AA) have been found to have persistently higher mean blood glucose (MBG) than European ancestry (EA) patients. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- AHCL pump and Video conferencing Application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- T1D as defined by:
- Typical clinical presentation at diagnosis
- Prior documentation of one or more anti-pancreatic antibodies
- Requiring >0.3 units/kg/d insulin therapy
- On no oral hypoglycemic agents concurrently
- Body mass index (BMI) <90% for age and gender
Show all 17Show fewer
- T1D duration of ≥ 6 months
- Self-identification as of African ancestry (AA)
- Age 10-17 years inclusive
- Pre-recruitment HbA1c 8.6-12%
- Glucose meter MBG ≥ 200 mg/dL
- Have smartphone/tablet/computer for conferencing
- Willingness to download and use the app for conferencing
- Willingness to be randomized to one of the clinical arms of the study (for Randomized intervention trial)
- Willingness and ability to wear pump and sensor, maintain equipment, and upload data from the system
- In stable living environment with a parent or guardian trained and able to recognize and intervene in diabetes emergency such as DKA or hypoglycemia
- Willingness to attend clinic visits during study at 3 and 6 month intervals
Who cannot join
- Unwillingness or inability to be randomized and/or participate in study procedures
- Pregnancy/plans to become pregnant/immediate post pregnancy and breast feeding
- Smoking, alcohol use, illicit drug use
- Severe psychiatric illness of patient or parent/guardian
- More than one (1) episode of diabetic ketoacidosis (DKA) in the past year
- Inability to wear sensor and/or pump catheter
Show all 15Show fewer
- Known allergy to medical adhesives
- Less than two (2) clinic visits in the past year
- Absence of anti-pancreatic antibodies at diagnosis
- BMI ≥90%
- Hypoglycemic unawareness associated with severe episodes of hypoglycemia
- Insulin requirement <0.3 units/kg/d
- On hypoglycemic agent besides insulin within prior 6 months or other medication which in the judgment of the investigator may be a contraindication to participation in the study.
- Other chronic illness or condition besides diabetes (exception for hypothyroidism if stable on thyroxine replacement therapy) that would interfere in patient or family's participation in the study, or would influence metabolic control or HbA1c interpretation
- Inability to participate in "run-in" pre-randomization activities for randomized trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Stuart A Chalew, M.D., 504-896-9441, schale@lsuhsc.edu
Sonja Washington, R.N., 504 896 9441, sonja.washington@lcmchealth.org
About this study
Type 1 diabetes (T1D), is associated with considerable risk of morbidity and mortality due to chronic hyperglycemia. Despite innovations in management, pediatric patients of African ancestry (AA) have been found to have persistently higher mean blood glucose (MBG) than European ancestry (EA) patients. The investigators hypothesize that an intervention using advanced insulin delivery technology together with home management will sustainably improve MBG to levels comparable to EA patients without increasing hypoglycemia.
The investigators will first perform a small "field trial" of the intervention in African American patients having T1D, with 8.5<HbA1c<12% aged 10-17 years. The primary intervention approach will use a combination of an advanced hybrid closed loop (AHCL) pump + enhanced home video management conferencing with study CDE nurse coordinator. Information gained in the "field trial" will be used to more specifically tailor the intervention in a randomized trial.
In the second part , the investigators will conduct a randomized trial of the study intervention in participants with the same clinical features as the field trial for a six month pilot period. Participants will be randomized into one of four groups. The special intervention group (AHCL+conferencing) group will be compared with a group using patient's current insulin management+followup, vs AHCL+without conferencing, vs patient's standard insulin management+conferencing. The investigators will compare HbA1c, MBG, time in glycemic range, ability to adhere with home management, satisfaction with management procedures between the groups.
Read the detailed description
Type 1 diabetes (T1D), one of the most prevalent incurable diseases of childhood, is associated with serious risk of morbidity and mortality due to the development of micro- and macrovascular complications. Complications can be prevented by treatment that achieves physiological or near physiological levels of glucose. Despite innovations in management over the past three decades, pediatric patients of African ancestry (AA) have had persistently higher HbA1c than patients of white, European ancestry (EA). Higher HbA1c in AA patients is associated with both higher acute and chronic morbidity and mortality compared to EA patients. Thus, racial disparity in glycemic outcome and the development of complications is a major unresolved challenge of current clinical pediatric diabetes treatment.
Multiple factors contribute to high-risk levels of mean blood glucose (MBG) in pediatric AA patients compared to EA. AA patients have less access to insulin pumps, perform glucose testing less often, have less contact with diabetes management staff, and may have difficulty relating to management staff due to cultural and socioeconomic differences. Greater occurrence of hypoglycemia is another obstacle to achieving optimal glucose control. These considerations have led us to hypothesize that an intervention targeting this group of major management obstacles will sustainably reduce MBG to levels comparable to EA patients without increased hypoglycemia. The investigators propose that an advanced hybrid closed loop (AHCL) pump system combined with frequent enhanced home video management conferencing (TECH) with the study CDE nurse coordinator will facilitate improvement of MBG and HbA1c, increase time in glycemic goal range, have minimal occurrence of hypoglycemia, and improve patient satisfaction with management.
Part 1: The investigators will first pre-test the intervention approach in ten participants using a combination of an advanced hybrid closed loop (AHCL) pump system + home video conferences with the study CDE nurse coordinator to enhance home management. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5<HbA1c<12%, age 10-17 years. The field trial will be for a 4 week period. THe investigators will use feedback and experience during the "field trial" from patients, parents and the study coordinator to refine the intervention and reduce patient problems with the technology, enhance its effectiveness improve participant adherence to management. This information will help guide/refine the design and use of the technologies in a randomized intervention trial (Part 2). Participants may choose to continue using the technologies after the initial 4 week Field Trial period for up to 6 months. AHCL must be returned at the end of participation.
Part 2: The investigators will conduct a randomized intervention trial in a factorial four group design comparing outcome measures in participants assigned to the combined AHCL+conferencing, versus use of AHCL or conferencing alone versus usual care. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5<HbA1c<12%, age 10-17 years. Outcome measures will be assessed at 3 and 6 month study visits. The major outcome metric will be HbA1c. In addition mean blood glucose (MBG), time in range, frequency of hyper/hypoglycemia, quality of life and treatment satisfaction will be compared between groups, Participation will be concluded at the 6 month visit. AHCL must be returned at the end of participation.
- Conditions
- Type1diabetes
- Being tested
- AHCL pump, Video conferencing Application
- Keywords
- type1diabetes, health disparity, pediatrics, advanced hydbrid closed loop insulin pump, youth, HbA1c, teleconferencing, racial disparity, continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHCL pumpDevice
Advanced Hybrid Closed Loop (AHCL) pump automatically adjusts insulin infusion rate of pump customized to patient's needs to reduce occurrence of hypo and hyperglycemia
Video conferencing ApplicationOther
Video conferencing application will be used to enhance communication between participant and parent with the study certified diabetes educator (CDE) nurse coordinator. These individualized sessions will be designed to help the family with solving diabetes management problems to enhance glycemic control
| Study group | Role | What they receive |
|---|---|---|
| Current Diabetes Management Continued | No intervention | Continued Insulin Delivery Method and Current Clinic Care of Diabetes |
| Video Conferencing+Current Insulin Delivery | Experimental | Patients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator Receives: Other: Video conferencing Application |
| AHCL pump without Video Conferencing | Experimental | Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support Receives: Device: AHCL pump |
| AHCL pump+Video Conferencing | Experimental | Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing Receives: Device: AHCL pump; Other: Video conferencing Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study)
Hemoglobin A1c (Glycated hemoglobin)
Measured: Change in HbA1c will be assessed from baseline to the HbA1c at 6 months (end of study)
Secondary outcomes (1)
Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)
Mean glucose levels as estimated from recorded glucose meter and sensor data
Measured: Change in MBG will be assessed at baseline and compared with 6 month measure (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital New Orleans, LA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Chalew, Children's Hospital New Orleans, LA
- Investigators
- Stuart A Chalew, M.D., Principal investigator, Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614623
- Sponsor's protocol ID
- R21DK118643
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.
PubMed 25901501Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
PubMed 27629148Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Service FJ, O'Brien PC. The relation of glycaemia to the risk of development and progression of retinopathy in the Diabetic Control and Complications Trial. Diabetologia. 2001 Oct;44(10):1215-20. doi: 10.1007/s001250100635.
PubMed 11692169Ryan CM, van Duinkerken E, Rosano C. Neurocognitive consequences of diabetes. Am Psychol. 2016 Oct;71(7):563-576. doi: 10.1037/a0040455.
PubMed 27690485Rewers MJ, Pillay K, de Beaufort C, Craig ME, Hanas R, Acerini CL, Maahs DM; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:102-14. doi: 10.1111/pedi.12190. No abstract available.
PubMed 25182311American Diabetes Association. Standards of medical care in diabetes: children and adolescents. Diabetes Care. 2015;38 (Supplement 1):S70-S6.
Hanson CL, Henggeler SW, Burghen GA. Race and sex differences in metabolic control of adolescents with IDDM: a function of psychosocial variables? Diabetes Care. 1987 May-Jun;10(3):313-8. doi: 10.2337/diacare.10.3.313.
PubMed 3595397Auslander WF, Anderson BJ, Bubb J, Jung KC, Santiago JV. Risk factors to health in diabetic children: a prospective study from diagnosis. Health Soc Work. 1990 May;15(2):133-42. doi: 10.1093/hsw/15.2.133.
PubMed 2365239Delamater AM, Albrecht DR, Postellon DC, Gutai JP. Racial differences in metabolic control of children and adolescents with type I diabetes mellitus. Diabetes Care. 1991 Jan;14(1):20-5. doi: 10.2337/diacare.14.1.20.
PubMed 1991431Chalew SA, Gomez R, Butler A, Hempe J, Compton T, Mercante D, Rao J, Vargas A. Predictors of glycemic control in children with type 1 diabetes: the importance of race. J Diabetes Complications. 2000 Mar-Apr;14(2):71-7. doi: 10.1016/s1056-8727(00)00072-6.
PubMed 10959068Petitti DB, Klingensmith GJ, Bell RA, Andrews JS, Dabelea D, Imperatore G, Marcovina S, Pihoker C, Standiford D, Waitzfelder B, Mayer-Davis E; SEARCH for Diabetes in Youth Study Group. Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study. J Pediatr. 2009 Nov;155(5):668-72.e1-3. doi: 10.1016/j.jpeds.2009.05.025. Epub 2009 Jul 29.
PubMed 19643434Kamps JL, Hempe JM, Chalew SA. Racial disparity in A1C independent of mean blood glucose in children with type 1 diabetes. Diabetes Care. 2010 May;33(5):1025-7. doi: 10.2337/dc09-1440. Epub 2010 Feb 25.
PubMed 20185743Redondo MJ, Connor CG, Ruedy KJ, Beck RW, Kollman C, Wood JR, Buckingham B, Klingensmith GJ, Silverstein J, Tamborlane WV; Pediatric Diabetes Consortium. Pediatric Diabetes Consortium Type 1 Diabetes New Onset (NeOn) Study: factors associated with HbA1c levels one year after diagnosis. Pediatr Diabetes. 2014 Jun;15(4):294-302. doi: 10.1111/pedi.12061. Epub 2013 Jul 24.
PubMed 23889707Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774.
PubMed 25687140
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D
- ClinicalTrials.gov ID
- NCT04614623
- Acronym / sponsor ID
- R21DK118643
- Conditions
- Type1diabetes
- Keywords
- type1diabetes, health disparity, pediatrics, advanced hydbrid closed loop insulin pump, youth, HbA1c, teleconferencing, racial disparity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital New Orleans, LAUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes (T1D), is associated with considerable risk of morbidity and mortality due to chronic hyperglycemia. Despite innovations in management, pediatric patients of African ancestry (AA) have been found to have persistently higher mean blood glucose (MBG) than European ancestry (EA) patients. The investigators hypothesize that an intervention using advanced insulin delivery technology together with home management will sustainably improve MBG to levels comparable to EA patients without increasing hypoglycemia.
The investigators will first perform a small "field trial" of the intervention in African American patients having T1D, with 8.5<HbA1c<12% aged 10-17 years. The primary intervention approach will use a combination of an advanced hybrid closed loop (AHCL) pump + enhanced home video management conferencing with study CDE nurse coordinator. Information gained in the "field trial" will be used to more specifically tailor the intervention in a randomized trial.
In the second part , the investigators will conduct a randomized trial of the study intervention in participants with the same clinical features as the field trial for a six month pilot period. Participants will be randomized into one of four groups. The special intervention group (AHCL+conferencing) group will be compared with a group using patient's current insulin management+followup, vs AHCL+without conferencing, vs patient's standard insulin management+conferencing. The investigators will compare HbA1c, MBG, time in glycemic range, ability to adhere with home management, satisfaction with management procedures between the groups.
Detailed description
Type 1 diabetes (T1D), one of the most prevalent incurable diseases of childhood, is associated with serious risk of morbidity and mortality due to the development of micro- and macrovascular complications. Complications can be prevented by treatment that achieves physiological or near physiological levels of glucose. Despite innovations in management over the past three decades, pediatric patients of African ancestry (AA) have had persistently higher HbA1c than patients of white, European ancestry (EA). Higher HbA1c in AA patients is associated with both higher acute and chronic morbidity and mortality compared to EA patients. Thus, racial disparity in glycemic outcome and the development of complications is a major unresolved challenge of current clinical pediatric diabetes treatment.
Multiple factors contribute to high-risk levels of mean blood glucose (MBG) in pediatric AA patients compared to EA. AA patients have less access to insulin pumps, perform glucose testing less often, have less contact with diabetes management staff, and may have difficulty relating to management staff due to cultural and socioeconomic differences. Greater occurrence of hypoglycemia is another obstacle to achieving optimal glucose control. These considerations have led us to hypothesize that an intervention targeting this group of major management obstacles will sustainably reduce MBG to levels comparable to EA patients without increased hypoglycemia. The investigators propose that an advanced hybrid closed loop (AHCL) pump system combined with frequent enhanced home video management conferencing (TECH) with the study CDE nurse coordinator will facilitate improvement of MBG and HbA1c, increase time in glycemic goal range, have minimal occurrence of hypoglycemia, and improve patient satisfaction with management.
Part 1: The investigators will first pre-test the intervention approach in ten participants using a combination of an advanced hybrid closed loop (AHCL) pump system + home video conferences with the study CDE nurse coordinator to enhance home management. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5<HbA1c<12%, age 10-17 years. The field trial will be for a 4 week period. THe investigators will use feedback and experience during the "field trial" from patients, parents and the study coordinator to refine the intervention and reduce patient problems with the technology, enhance its effectiveness improve participant adherence to management. This information will help guide/refine the design and use of the technologies in a randomized intervention trial (Part 2). Participants may choose to continue using the technologies after the initial 4 week Field Trial period for up to 6 months. AHCL must be returned at the end of participation.
Part 2: The investigators will conduct a randomized intervention trial in a factorial four group design comparing outcome measures in participants assigned to the combined AHCL+conferencing, versus use of AHCL or conferencing alone versus usual care. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5<HbA1c<12%, age 10-17 years. Outcome measures will be assessed at 3 and 6 month study visits. The major outcome metric will be HbA1c. In addition mean blood glucose (MBG), time in range, frequency of hyper/hypoglycemia, quality of life and treatment satisfaction will be compared between groups, Participation will be concluded at the 6 month visit. AHCL must be returned at the end of participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Current Diabetes Management Continued | No intervention | –Continued Insulin Delivery Method and Current Clinic Care of Diabetes |
| Video Conferencing+Current Insulin Delivery | Experimental | Other: Video conferencing ApplicationPatients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator |
| AHCL pump without Video Conferencing | Experimental | Device: AHCL pumpPatients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support |
| AHCL pump+Video Conferencing | Experimental | Device: AHCL pump, Other: Video conferencing ApplicationPatients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- T1D as defined by:
- T1D duration of ≥ 6 months
- Self-identification as of African ancestry (AA)
- Age 10-17 years inclusive
- Pre-recruitment HbA1c 8.6-12%
Key exclusion criteria (15 listed)
- Unwillingness or inability to be randomized and/or participate in study procedures
- Pregnancy/plans to become pregnant/immediate post pregnancy and breast feeding
- Smoking, alcohol use, illicit drug use
- Severe psychiatric illness of patient or parent/guardian
- More than one (1) episode of diabetic ketoacidosis (DKA) in the past year
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 |
|---|---|---|
| AHCL pumpAdvanced Hybrid Closed Loop (AHCL) pump automatically adjusts insulin infusion rate of pump customized to patient's needs to reduce occurrence of hypo and hyperglycemia | Device | AHCL pump without Video Conferencing, AHCL pump+Video Conferencing |
| Video conferencing ApplicationVideo conferencing application will be used to enhance communication between participant and parent with the study certified diabetes educator (CDE) nurse coordinator. These individualized sessions will be designed to help the family with solving diabetes management problems to enhance glycemic control | Other | AHCL pump+Video Conferencing, Video Conferencing+Current Insulin Delivery |
Primary outcome
Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study)
Time frame: Change in HbA1c will be assessed from baseline to the HbA1c at 6 months (end of study)
Hemoglobin A1c (Glycated hemoglobin)
1 secondary outcome
Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)
Time frame: Change in MBG will be assessed at baseline and compared with 6 month measure (study end)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 25901501Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.
- Background: PubMed 27629148Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 11692169Service FJ, O'Brien PC. The relation of glycaemia to the risk of development and progression of retinopathy in the Diabetic Control and Complications Trial. Diabetologia. 2001 Oct;44(10):1215-20. doi: 10.1007/s001250100635.
- Background: PubMed 27690485Ryan CM, van Duinkerken E, Rosano C. Neurocognitive consequences of diabetes. Am Psychol. 2016 Oct;71(7):563-576. doi: 10.1037/a0040455.
- Background: PubMed 25182311Rewers MJ, Pillay K, de Beaufort C, Craig ME, Hanas R, Acerini CL, Maahs DM; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:102-14. doi: 10.1111/pedi.12190. No abstract available.
- BackgroundAmerican Diabetes Association. Standards of medical care in diabetes: children and adolescents. Diabetes Care. 2015;38 (Supplement 1):S70-S6.
- Background: PubMed 3595397Hanson CL, Henggeler SW, Burghen GA. Race and sex differences in metabolic control of adolescents with IDDM: a function of psychosocial variables? Diabetes Care. 1987 May-Jun;10(3):313-8. doi: 10.2337/diacare.10.3.313.
- Background: PubMed 2365239Auslander WF, Anderson BJ, Bubb J, Jung KC, Santiago JV. Risk factors to health in diabetic children: a prospective study from diagnosis. Health Soc Work. 1990 May;15(2):133-42. doi: 10.1093/hsw/15.2.133.
- Background: PubMed 1991431Delamater AM, Albrecht DR, Postellon DC, Gutai JP. Racial differences in metabolic control of children and adolescents with type I diabetes mellitus. Diabetes Care. 1991 Jan;14(1):20-5. doi: 10.2337/diacare.14.1.20.
- Background: PubMed 10959068Chalew SA, Gomez R, Butler A, Hempe J, Compton T, Mercante D, Rao J, Vargas A. Predictors of glycemic control in children with type 1 diabetes: the importance of race. J Diabetes Complications. 2000 Mar-Apr;14(2):71-7. doi: 10.1016/s1056-8727(00)00072-6.
- Background: PubMed 19643434Petitti DB, Klingensmith GJ, Bell RA, Andrews JS, Dabelea D, Imperatore G, Marcovina S, Pihoker C, Standiford D, Waitzfelder B, Mayer-Davis E; SEARCH for Diabetes in Youth Study Group. Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study. J Pediatr. 2009 Nov;155(5):668-72.e1-3. doi: 10.1016/j.jpeds.2009.05.025. Epub 2009 Jul 29.
- Individual participant dataSharing planned: No
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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.
Stuart A Chalew, M.D. principal investigator
Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHCL pump and Video conferencing Application in people with Type1diabetes, run by Children's Hospital New Orleans, LA 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 17 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stuart A Chalew, M.D. (504 896 9441, schale@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study) (time frame: Change in HbA1c will be assessed from baseline to the HbA1c at 6 months (end of study)). 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 NCT04614623, which also lists 60 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 4 Nov 2020.