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Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Insulin Degludec

Insulin Glargine

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment
HbA1c ≥8.5%9 and <14% on enrollment
Taking no medications known to affect blood glucose levels other than insulin.
Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is < age 18 before any trial-related activities
Current regimen includes insulin detemir or I-glar, as long acting insulin
Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration
Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week
Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check

Exclusion Criteria:

Female participants who are pregnant, breast-feeding or planning on becoming pregnant
Participant (and parent if age <18) unable to read, write, and speak English.
Adolescents who are home schooled or no longer attending secondary school
Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels
Known or suspected allergy to trial medication(s), excipients, or related products.
Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

subjects receiving insulin degludec

Subjects receiving insulin glargine

Arm Description

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.

Outcomes

Primary Outcome Measures

Lower beta hydroxybutyrate levels

Will test the the hypothesis that β-hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving I-deg, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays.

Secondary Outcome Measures

Control of HbA1c levels

Test the hypothesis that the longer duration of action of I-deg will lead to improvements in glycemic control measured by HbA1c (a secondary aim) and fasting glucose.

Measure of beta hydroxybutyrate levels between the 2 groups.

Test the differences in frequency of elevated β-hydroxybutyrate levels when receiving supervised injections of basal insulin versus when not receiving supervised injections between the I-deg and I-glar groups

Full Information

NCT ID

NCT03400501

First Posted

January 9, 2018

Last Updated

November 4, 2021

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03400501

Brief Title

Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

Official Title

Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

June 7, 2021 (Actual)

Study Completion Date

June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.

Detailed Description

This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/L at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays. To remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

subjects receiving insulin degludec

Arm Type

Experimental

Arm Description

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.

Arm Title

Subjects receiving insulin glargine

Arm Type

Active Comparator

Arm Description

Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.

Intervention Type

Drug

Intervention Name(s)

Insulin Degludec

Other Intervention Name(s)

I-degludec

Intervention Description

Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Other Intervention Name(s)

I-glar

Intervention Description

Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose

Primary Outcome Measure Information:

Title

Lower beta hydroxybutyrate levels

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Control of HbA1c levels

Description

Test the hypothesis that the longer duration of action of I-deg will lead to improvements in glycemic control measured by HbA1c (a secondary aim) and fasting glucose.

Time Frame

4 months

Title

Measure of beta hydroxybutyrate levels between the 2 groups.

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment HbA1c ≥8.5%9 and <14% on enrollment Taking no medications known to affect blood glucose levels other than insulin. Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is < age 18 before any trial-related activities Current regimen includes insulin detemir or I-glar, as long acting insulin Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check Exclusion Criteria: Female participants who are pregnant, breast-feeding or planning on becoming pregnant Participant (and parent if age <18) unable to read, write, and speak English. Adolescents who are home schooled or no longer attending secondary school Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels Known or suspected allergy to trial medication(s), excipients, or related products. Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Tamborlane, PhD

Organizational Affiliation

MED School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

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