NCT03034759

Brief Summary

We aim to test the efficacy of a new method for determining individual insulin sensitivity (IS) based on sensor-augmented-insulin pump (SAP) data in order to customize the insulin to carbohydrate ratio (CR) in adolescents with type 1 diabetes (T1D). To date, the individual insulin sensitivity (IS) could only be investigated by intensive and invasive research techniques that are not feasible to perform in an outpatient setting for pediatric patients with diabetes. Recently published studies have demonstrated the efficacy of an algorithm to calculate the patient specific insulin sensitivity to customize the CR for adult patients with T1D. The algorithm has been validated in adult patients, however not yet investigated in the pediatric population with T1D. The aims of our study are:

  1. 1.to customize the CR of pediatric subjects with T1D using the individualized insulin sensitivity index (ISind) to improve post-prandial blood glucose control after a standard meal.
  2. 2.to test, under free living condition (at home), the efficacy of the customized CR in improving post-prandial glycemic control for pediatric subjects with T1D.
  3. 3.To provide a non-invasive tool for individualizing their home insulin therapy;
  4. 4.To offer a reliable instrument for adjusting the meal bolus of the current hybrid closed loop (HCL) systems to account for the inter-subject variability in insulin action.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

January 24, 2017

Last Update Submit

July 10, 2019

Conditions

Diabetes Mellitus

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • overall time in target (70-180mg/dl)

    the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)\*100.

    4 weeks

Secondary Outcomes (34)

  • median percentage of time spent in hypoglycemia (<70mg/dl) during control period

    4 weeks

  • median percentage of time spent in hypoglycemia (<70mg/dl) post meal 1

    180 minutes post meal

  • median percentage of time spent in hypoglycemia (<70mg/dl) post meal 2

    180 minutes post meal

  • median percentage of time spent in hypoglycemia (<70mg/dl) post meal 3

    180 minutes post meal

  • median percentage of time spent in hypoglycemia (<70mg/dl) during Intervention phase

    4 weeks

  • +29 more secondary outcomes

Study Arms (1)

All participants

EXPERIMENTAL

+Pediatric patients with T1D. All comparisons will be made within group pre and post intervention.

Other: individualized insulin sensitivity index (ISind)

Interventions

individualized insulin sensitivity index (ISind)OTHER

The new insulin sensitivity index, named "SISP" is calculated from data derived from insulin pump and glucose monitoring (CGM) uploads.

All participants

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-21 year old.
  • Clinical diagnosis of T1D ≥1 year
  • Treatment with sensor augmented pump therapy (insulin pump + glucose sensor) for at least 1 month
  • HbA1c \<10%
  • Be able to comprehend written and spoken English

You may not qualify if:

  • Pregnancy, breast feeding, or plans to get pregnant for the next 12 months
  • On medications that affect insulin sensitivity; has other medical conditions known to affect insulin sensitivity;
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Pediatric Diabetes Research Program

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eda Cengiz, MD

    Yale University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 27, 2017

Study Start

October 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 1, 2022

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

US(1)