Diabetes MellitusPhase 4NCT04157738
A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
A Phase 4 study testing Rapid-Acting Insulin and Long acting insulin in people with Diabetes Mellitus and Type 1 Diabetes, run by Emory University at 1 site in United States.
Trial summary
Type 1 diabetes mellitus (T1DM) is a challenging medical disorder, especially in children and adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance of near-normal glycemic control must be balanced with minimizing hypoglycemia. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes
- What is being tested?
- Rapid-Acting Insulin and Long acting insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2019to 17 Dec 2020
- Phase
- Phase 4
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have Confirmed diagnosis of T1DM based on the most recent ADA criteria
- Be 7 - 15 years of age
- Begin monitoring with a glucose monitor prior to discharge from the hospital
- Have the ability to understand and be willing to adhere to the study protocol
- English or Spanish speakers
Who cannot join
- Have a clinically significant major organ system disease
- Be on glucocorticoid therapy
- Have Type 2 Diabetes Mellitus
- Have Polycystic Ovarian Syndrome (PCOS)
- Have a BMI > 85th %ile
- Have Acanthosis Nigricans
Show all 14Show fewer
- Have any form of renal impairment
- Have Cystic Fibrosis
- Have Glucocorticoid-, Chemotherapeutic-, or any other Medication-induced form of Diabetes
- Be using any basal insulin other than Glargine insulin
- Have cognitive impairment (> 2 grades behind age-appropriate grade in school)
- Be in Foster Care
- Have any history of Division of Family and Children Services (DFCS) involvement
- If female, be pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Fixed Dose for Fixed Carbohydrates vs. Variable Dosing for Variable Carbohydrates: A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus.
Type 1 diabetes mellitus (T1DM) is a challenging medical disorder, especially in children and adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance of near-normal glycemic control must be balanced with minimizing hypoglycemia. Although many pediatric endocrinologists provide an ICR plan for their newly diagnosed patients with T1DM, fixed dosing and other forms of insulin delivery are available. This proposal is designed to compare children and adolescents with newly diagnosed T1DM using a fixed insulin dose for fixed carbohydrate mealtime regimen (FIXED group) to children and adolescents with newly diagnosed T1DM using an ICR with variable carbohydrate intake (ICR group) mealtime regimen. In addition to determining the feasibility for a subsequently larger clinical trial, the aims of this investigator-initiated, prospective proposal, is twofold. The first is to determine if the caregivers of diabetics using a fixed insulin for fixed carbohydrate regimen (FIXED group) experience less anxiety than the caregivers of those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization. The second is to determine if diabetics utilizing a fixed insulin for fixed carbohydrate regimen (FIXED group) have decreased glycemic variability (GV) than those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization.
Read the detailed description
Although children and adolescents with T1DM have much more freedom with the amount of food (carbohydrates) they eat while using an ICR at mealtime, the difficulty in determining the amount of insulin needed, how and when to adjust the ICR, the difficulty with understanding the basics of managing T1DM, and the adaptation to a new lifestyle with T1DM may be more complicated than utilizing a simple plan that includes a fixed amount of insulin and fixed number of carbohydrates, at least for the first few months after diagnosis. As complicated as it is for children, adolescents, and their caregivers to learn how to manage T1DM after being discharged home in usually < 48 hours after diagnosis, a more simplified insulin regimen at mealtime may provide the family of and the child or adolescent with newly diagnosed T1DM with less stress and anxiety while still maintaining adequate glycemic control. Twenty - 40 subjects will be recruited at Children's Hospital of Atlanta (CHOA) at Egleston and will be randomized to either the FIXED group or the ICR group according to a computer-generated random sampling table. The subject and his/her caregivers will receive diabetes education while in the hospital in standard fashion. The subject and his/her caregivers will receive glucose monitoring education and training prior to hospital discharge. The subject and his/her caregivers will also receive a paper log to record the blood sugars, number of carbohydrates consumed and insulin administered at each meal throughout the day.
Prior to discharge, all subjects will receive a regimen that includes a: 1) Meal-time insulin and carbohydrate regimen (# of units of insulin, # of carbohydrates, and/or ICR); 2) Daily dose of Glargine; 3) Hyperglycemia correction regimen for blood glucose levels > 199 mg/dL; and 4) Hypoglycemia treatment regimen for blood glucose levels < 70 mg/dL and/or symptomatic.
As per standard diabetes care, caregivers will report all blood glucose levels every day (to the study investigators) until the subject's initial clinic visit 4-6 weeks after diagnosis. All insulin adjustments will be made by the study investigators.
After the subject's first clinic visit, caregivers will contact the study investigators once a week to report blood glucose levels and the investigators will make adjustments as needed.
All the diabetes clinic visits will occur at the Center for Advanced Pediatrics (CAP), approximately three miles from CHOA-Egleston Hospital. Subjects will attend clinic with one or more of the investigators approximately 1 and 4 months after enrollment.
At each clinic visit, subjects (and their caregivers) will answer standard diabetes questions, subjects will undergo a physical examination, and subjects' objective data (vital signs, glucose meter (GM) data, insulin dosing, and carbohydrate intake) will be collected by the study personnel.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes
- Being tested
- Rapid-Acting Insulin, Long acting insulin
- Keywords
- Diabetes, Glycemic variability, Insulin, Parental Stress, Advanced carbohydrates counting, Insulin for meals
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid-Acting InsulinDrug
Also called Lispro, Aspart, glulisine
Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulinDrug
Also called Glargine
Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
| Study group | Role | What they receive |
|---|---|---|
| Fixed Group | Experimental | Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent. Receives: Drug: Rapid-Acting Insulin; Drug: Long acting insulin |
| Insulin to carbohydrate ratio (ICR) Group | Active comparator | Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Receives: Drug: Rapid-Acting Insulin; Drug: Long acting insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of All Consented Participants
The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Measured: 4 months post-intervention
Number of Participants That Completed All Visits
Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization.
Measured: 4 months post-intervention
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
Caregiver treatment adherence was assessed using a blood glucose log. Subjects and caregivers recorded blood glucose levels and the amount/type of insulin given. This data was used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence).
Measured: 1 month post-intervention and 4 months post-intervention
Secondary outcomes (2)
Caregiver Anxiety
Caregiver anxiety was measured with the "parental stress scale". Caregivers completed the "parental stress scale" at initial enrollment and at each clinic follow up visit. The Parental Stress Scale includes 18 questions that are rated from 1 (strongly disagree) to 5 (strongly agree). Scoring ranges from 18 - 90. The higher the score, the higher the stress and anxiety level.
Measured: Baseline, 1 month post-intervention, 4 months post-intervention
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
The GV was calculated in all subjects using the average blood glucose levels collected from the daily blood glucose paper log. A subjective qualification system was used to label each subject's GV based on their blood glucose levels and an established glucose monitoring (GM) data system. Subjects are considered to have appropriate GV if their blood glucose levels are in the range of 80 mg/dL - 180 mg/dL. Percentage of participants within each specific average BG range is shown.
Measured: 1 month post-intervention, 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start27 Nov 2019
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Felner, MD, MSCR, Emory University
- Investigators
- Eric I Felner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157738
- Sponsor's protocol ID
- IRB00114078
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2019
- Last updated
- 30 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diaz JVR, Figueroa J, Felner EI. A pilot study of mealtime insulin administration and parental stress in youth with new-onset type 1 diabetes. Diabet Med. 2023 Apr;40(4):e15039. doi: 10.1111/dme.15039. Epub 2023 Jan 19.
PubMed 36617389
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Dose for Fixed Carbohydrates vs. Variable Dosing for Variable Carbohydrates: A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04157738
- Acronym / sponsor ID
- IRB00114078
- Conditions
- Diabetes Mellitus, Type 1 Diabetes
- Keywords
- Diabetes, Glycemic variability, Insulin, Parental Stress, Advanced carbohydrates counting, Insulin for meals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 30 Sep 2021
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 mellitus (T1DM) is a challenging medical disorder, especially in children and adolescents. In order to prevent the chronic complications of hyperglycemia, the maintenance of near-normal glycemic control must be balanced with minimizing hypoglycemia. Although many pediatric endocrinologists provide an ICR plan for their newly diagnosed patients with T1DM, fixed dosing and other forms of insulin delivery are available. This proposal is designed to compare children and adolescents with newly diagnosed T1DM using a fixed insulin dose for fixed carbohydrate mealtime regimen (FIXED group) to children and adolescents with newly diagnosed T1DM using an ICR with variable carbohydrate intake (ICR group) mealtime regimen. In addition to determining the feasibility for a subsequently larger clinical trial, the aims of this investigator-initiated, prospective proposal, is twofold. The first is to determine if the caregivers of diabetics using a fixed insulin for fixed carbohydrate regimen (FIXED group) experience less anxiety than the caregivers of those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization. The second is to determine if diabetics utilizing a fixed insulin for fixed carbohydrate regimen (FIXED group) have decreased glycemic variability (GV) than those using an ICR with variable carbohydrate intake regimen (ICR group) at 1- and 4-months post-randomization.
Detailed description
Although children and adolescents with T1DM have much more freedom with the amount of food (carbohydrates) they eat while using an ICR at mealtime, the difficulty in determining the amount of insulin needed, how and when to adjust the ICR, the difficulty with understanding the basics of managing T1DM, and the adaptation to a new lifestyle with T1DM may be more complicated than utilizing a simple plan that includes a fixed amount of insulin and fixed number of carbohydrates, at least for the first few months after diagnosis. As complicated as it is for children, adolescents, and their caregivers to learn how to manage T1DM after being discharged home in usually < 48 hours after diagnosis, a more simplified insulin regimen at mealtime may provide the family of and the child or adolescent with newly diagnosed T1DM with less stress and anxiety while still maintaining adequate glycemic control. Twenty - 40 subjects will be recruited at Children's Hospital of Atlanta (CHOA) at Egleston and will be randomized to either the FIXED group or the ICR group according to a computer-generated random sampling table. The subject and his/her caregivers will receive diabetes education while in the hospital in standard fashion. The subject and his/her caregivers will receive glucose monitoring education and training prior to hospital discharge. The subject and his/her caregivers will also receive a paper log to record the blood sugars, number of carbohydrates consumed and insulin administered at each meal throughout the day.
Prior to discharge, all subjects will receive a regimen that includes a: 1) Meal-time insulin and carbohydrate regimen (# of units of insulin, # of carbohydrates, and/or ICR); 2) Daily dose of Glargine; 3) Hyperglycemia correction regimen for blood glucose levels > 199 mg/dL; and 4) Hypoglycemia treatment regimen for blood glucose levels < 70 mg/dL and/or symptomatic.
As per standard diabetes care, caregivers will report all blood glucose levels every day (to the study investigators) until the subject's initial clinic visit 4-6 weeks after diagnosis. All insulin adjustments will be made by the study investigators.
After the subject's first clinic visit, caregivers will contact the study investigators once a week to report blood glucose levels and the investigators will make adjustments as needed.
All the diabetes clinic visits will occur at the Center for Advanced Pediatrics (CAP), approximately three miles from CHOA-Egleston Hospital. Subjects will attend clinic with one or more of the investigators approximately 1 and 4 months after enrollment.
At each clinic visit, subjects (and their caregivers) will answer standard diabetes questions, subjects will undergo a physical examination, and subjects' objective data (vital signs, glucose meter (GM) data, insulin dosing, and carbohydrate intake) will be collected by the study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Group | Experimental | Drug: Rapid-Acting Insulin, Drug: Long acting insulinChildren and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent. |
| Insulin to carbohydrate ratio (ICR) Group | Active comparator | Drug: Rapid-Acting Insulin, Drug: Long acting insulinChildren and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Have Confirmed diagnosis of T1DM based on the most recent ADA criteria
- Be 7 - 15 years of age
- Begin monitoring with a glucose monitor prior to discharge from the hospital
- Have the ability to understand and be willing to adhere to the study protocol
- English or Spanish speakers
Key exclusion criteria (14 listed)
- Have a clinically significant major organ system disease
- Be on glucocorticoid therapy
- Have Type 2 Diabetes Mellitus
- Have Polycystic Ovarian Syndrome (PCOS)
- Have a BMI > 85th %ile
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 |
|---|---|---|
| Rapid-Acting InsulinAlso: Lispro, Aspart, glulisinePrior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR) | Drug | Fixed Group, Insulin to carbohydrate ratio (ICR) Group |
| Long acting insulinAlso: GlarginePrior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine) | Drug | Fixed Group, Insulin to carbohydrate ratio (ICR) Group |
Primary outcome
Number of All Consented Participants
Time frame: 4 months post-intervention
The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Number of Participants That Completed All Visits
Time frame: 4 months post-intervention
Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization.
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
Time frame: 1 month post-intervention and 4 months post-intervention
Caregiver treatment adherence was assessed using a blood glucose log. Subjects and caregivers recorded blood glucose levels and the amount/type of insulin given. This data was used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence).
2 secondary outcomes
Caregiver Anxiety
Time frame: Baseline, 1 month post-intervention, 4 months post-intervention
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
Time frame: 1 month post-intervention, 4 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36617389Diaz JVR, Figueroa J, Felner EI. A pilot study of mealtime insulin administration and parental stress in youth with new-onset type 1 diabetes. Diabet Med. 2023 Apr;40(4):e15039. doi: 10.1111/dme.15039. Epub 2023 Jan 19.
- 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.
Eric I Felner, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid-Acting Insulin and Long acting insulin in people with Diabetes Mellitus and Type 1 Diabetes, run by Emory University 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 5 inclusion and 14 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 30 Sep 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2021). 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?
Number of All Consented Participants (time frame: 4 months post-intervention). The study lists 3 primary outcomes in all. 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 NCT04157738, which also lists 1 linked publication.
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 30 Sep 2021.