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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus (BEGIN™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
  • Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
  • Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
  • HbA1c (glycosylated haemoglobin) maximum 11%

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Previous participation in this trial. Participation is defined as randomisation
  • Girls who are pregnant, breastfeeding or intend to become pregnant
  • Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
  • Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
  • More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
  • Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
  • The receipt of any investigational drug within 1 month prior to Visit 1

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Insulin Degludec + Insulin Aspart

Insulin Detemir +Insulin Aspart

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
Change from baseline in HbA1c (%) after 26 weeks of treatment.

Secondary Outcome Measures

Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
Change from baseline in HbA1c (%) after 52 weeks of treatments.
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Change from baseline in FPG after 26 weeks of treatment.
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Change from baseline in FPG after 52 weeks of treatment.
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Number of Hypoglycaemic Episodes
Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
Episodes of PG >11.1mmol/L (200mg/dL)
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)

Full Information

First Posted
January 16, 2012
Last Updated
June 3, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01513473
Brief Title
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
Acronym
BEGIN™
Official Title
A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2012 (Actual)
Primary Completion Date
July 30, 2013 (Actual)
Study Completion Date
July 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Degludec + Insulin Aspart
Arm Type
Experimental
Arm Title
Insulin Detemir +Insulin Aspart
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
Description
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
Description
Change from baseline in HbA1c (%) after 52 weeks of treatments.
Time Frame
Week 0, week 52
Title
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Description
Change from baseline in FPG after 26 weeks of treatment.
Time Frame
Week 0, week 26
Title
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Description
Change from baseline in FPG after 52 weeks of treatment.
Time Frame
Week 0, week 52
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time Frame
After 26 weeks and 52 weeks of treatment
Title
Number of Hypoglycaemic Episodes
Description
Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)
Time Frame
After 26 weeks and 52 weeks of treatment
Title
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
Description
Episodes of PG >11.1mmol/L (200mg/dL)
Time Frame
After 26 weeks and 52 weeks of treatment
Title
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
Description
Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment
Time Frame
After 26 weeks and 52 weeks of treatment
Title
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
Description
Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.
Time Frame
Between week 1 and week 26
Title
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Description
Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)
Time Frame
After 52 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines) Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed HbA1c (glycosylated haemoglobin) maximum 11% Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products Previous participation in this trial. Participation is defined as randomisation Girls who are pregnant, breastfeeding or intend to become pregnant Girls who have had menarche and are not using adequate contraceptive measures according to local requirements Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician) More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial The receipt of any investigational drug within 1 month prior to Visit 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Espoo
ZIP/Postal Code
02740
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
OYS
ZIP/Postal Code
90029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
BRON cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Chuo-shi, Yamanashi
ZIP/Postal Code
409 3898
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukushima
ZIP/Postal Code
963-8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Iruma-gun, Saitama
ZIP/Postal Code
350 0495
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kobe-shi, Hyogo
ZIP/Postal Code
657-0846
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kochi-shi, Kochi
ZIP/Postal Code
780 0952
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi, Kumamoto
ZIP/Postal Code
860 8556
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Maebashi-shi, Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Musashino-shi, Tokyo
ZIP/Postal Code
180 0023
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Niigata-shi, Niigata
ZIP/Postal Code
951 8520
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
545 8586
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi, Miyagi
ZIP/Postal Code
980 8574
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
157 8535
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
162 8666
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Toyonaka-city, Osaka
ZIP/Postal Code
560 0004
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tsu-shi, Mie
ZIP/Postal Code
514 0125
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Amersfoort
ZIP/Postal Code
3816 CP
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Nijmegen
ZIP/Postal Code
6532 CL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 TA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
125373
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630048
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S102TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30666772
Citation
Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
Results Reference
background
PubMed Identifier
25683037
Citation
Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

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