A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04157738
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Type 1 Diabetes	Drug: Rapid-Acting Insulin; Drug: Long acting insulin	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Nov 27, 2019
• Actual Primary Completion Date: Dec 17, 2020
• Actual Study Completion Date: Dec 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fixed Group 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.	Drug: Rapid-Acting Insulin; 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); Other Names: Lispro, Aspart, glulisine ; Drug: Long acting insulin; Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine); Other Names: Glargine
Active Comparator: Insulin to carbohydrate ratio (ICR) Group Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen	Drug: Rapid-Acting Insulin; 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); Other Names: Lispro, Aspart, glulisine ; Drug: Long acting insulin; Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine); Other Names: Glargine

Outcome Measures

Primary Outcome Measures

1. Number of All Consented Participants [4 months post-intervention]

   The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).

2. Number of Participants That Completed All Visits [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.

3. Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention [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).

Secondary Outcome Measures

1. Caregiver Anxiety [Baseline, 1 month post-intervention, 4 months post-intervention]

   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.

2. Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention [1 month post-intervention, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Eric I Felner, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2019

More Information

Publications

None provided.

• Responsible Party: Eric Felner, MD, MSCR, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT04157738
• Other Study ID Numbers: IRB00114078
• First Posted: Nov 8, 2019
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Eric Felner, MD, MSCR, Professor, Emory University: Diabetes; Glycemic variability; Insulin; Parental Stress; Advanced carbohydrates counting; Insulin for meals
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Insulin, Long-Acting

Study Results

Participant Flow

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Period Title: Overall Study
STARTED	12	12
COMPLETED	11	10
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group	Total
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	10	11	11
Sex: Female, Male (Count of Participants)
Female	5 41.7%	8 66.7%	13 54.2%
Male	7 58.3%	4 33.3%	11 45.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%	2 16.7%	4 16.7%
Not Hispanic or Latino	10 83.3%	10 83.3%	20 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%
Onset with Acidosis (Count of Participants)
Yes	8 66.7%	8 66.7%	16 66.7%
No	4 33.3%	4 33.3%	8 33.3%
Pubertal at onset (Count of Participants)
Yes	5 41.7%	5 41.7%	10 41.7%
No	7 58.3%	7 58.3%	14 58.3%

Outcome Measures

1. Primary Outcome

Title	Number of All Consented Participants
Description	The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Time Frame	4 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Measure Participants	12	12
Count of Participants [Participants]	12 100%	12 100%

2. Primary Outcome

Title	Number of Participants That Completed All Visits
Description	Number of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization.
Time Frame	4 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Measure Participants	12	12
Count of Participants [Participants]	11 91.7%	10 83.3%

3. Primary Outcome

Title	Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
Description	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).
Time Frame	1 month post-intervention and 4 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Measure Participants	12	10
< 4 times/day at 1-month visit	3.2 26.7%	10.2 85%
≥ 4 times/day at 1-month visit	96.8 806.7%	89.8 748.3%
< 4 times/day at 4-month visit	2.6 21.7%	16.1 134.2%
≥ 4 times/day at 4-month visit	97.0 808.3%	83.9 699.2%

4. Secondary Outcome

Title	Caregiver Anxiety
Description	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.
Time Frame	Baseline, 1 month post-intervention, 4 months post-intervention

Outcome Measure Data

Analysis Population Description

Number of participants analyzed include subjects that had visits in-person at 1 month and 4 months post-randomization.

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Measure Participants	12	12
Baseline	29.1	30.2
1 month post-intervention	27.0	35.9
4 months post-intervention	27.6	34.4

5. Secondary Outcome

Title	Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
Description	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.
Time Frame	1 month post-intervention, 4 months post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed Group	Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)	Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
Measure Participants	12	10
BG < 50 mg/dL at 1 month post-intervention	0.5 4.2%	0.5 4.2%
BG 50-79 mg/dL at 1 month post-intervention	8.9 74.2%	8.3 69.2%
BG 80-180 mg/dL at 1 month post-intervention	67.5 562.5%	63.2 526.7%
BG 181-350 mg/dL at 1 month post-intervention	25.8 215%	26.8 223.3%
BG >350 mg/dL at 1 month post-intervention	0.8 6.7%	0.3 2.5%
BG < 50 mg/dL at 4 month post-intervention	0.0 0%	0.4 3.3%
BG 50-79 mg/dL at 4 month post-intervention	8.6 71.7%	7.3 60.8%
BG 80-180 mg/dL at 4 month post-intervention	63.3 527.5%	69.0 575%
BG 181-350 mg/dL at 4 month post-intervention	28.7 239.2%	21.8 181.7%
BG >350 mg/dL at 4 month post-intervention	0.1 0.8%	0.4 3.3%

Adverse Events

Time Frame	Data collected during follow up (until 4 months post-intervention).
Arm/Group Title	Fixed Group		Insulin to Carbohydrate Ratio (ICR) Group
Arm/Group Description	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. Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)		Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen Rapid-Acting Insulin: 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 insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
All Cause Mortality
	Fixed Group		Insulin to Carbohydrate Ratio (ICR) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Fixed Group		Insulin to Carbohydrate Ratio (ICR) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
General disorders
Altered Mentas Status	0/12 (0%)	0	0/12 (0%)	0
Metabolism and nutrition disorders
Severe Hypoglycemia	0/12 (0%)	0	0/12 (0%)	0
Diabetic Keoacidosis	0/12 (0%)	0	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Fixed Group		Insulin to Carbohydrate Ratio (ICR) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.