Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034759
Recruitment Status : Withdrawn (Investigator has moved to another institution)
First Posted : January 27, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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. 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. 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.

This approach would have at least two potential benefits for pediatric patients with T1D:

  1. To provide a non-invasive tool for individualizing their home insulin therapy;
  2. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: individualized insulin sensitivity index (ISind) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Wizard for Insulin Sensitivity Estimation From SAP: a Randomized Controlled Trial in Adolescents With T1D
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: All participants
+Pediatric patients with T1D. All comparisons will be made within group pre and post intervention.
Other: individualized insulin sensitivity index (ISind)
The new insulin sensitivity index, named "SISP" is calculated from data derived from insulin pump and glucose monitoring (CGM) uploads.




Primary Outcome Measures :
  1. overall time in target (70-180mg/dl) [ Time Frame: 4 weeks ]
    the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)*100.


Secondary Outcome Measures :
  1. median percentage of time spent in hypoglycemia (<70mg/dl) during control period [ Time Frame: 4 weeks ]
    the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)*100.

  2. median percentage of time spent in hypoglycemia (<70mg/dl) post meal 1 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  3. median percentage of time spent in hypoglycemia (<70mg/dl) post meal 2 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  4. median percentage of time spent in hypoglycemia (<70mg/dl) post meal 3 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  5. median percentage of time spent in hypoglycemia (<70mg/dl) during Intervention phase [ Time Frame: 4 weeks ]
    the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)*100.

  6. overall time in target (70-180mg/dl) after meal 1 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  7. overall time in target (70-180mg/dl) after meal 2 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  8. overall time in target (70-180mg/dl) after meal 3 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  9. overall time in target (70-180mg/dl) during Intervention phase [ Time Frame: 4 weeks ]
    the percentage of time in target will be calculated "(time in target/total time of records using continuous glucose monitoring)*100.

  10. median percentage of time in hyperglycemia (>180mg/dl) during Control Phase [ Time Frame: 4 weeks ]
    time in target/total time of records using continuous glucose monitoring)*100

  11. median percentage of time in hyperglycemia (>180mg/dl) after meal 1 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  12. median percentage of time in hyperglycemia (>180mg/dl) after meal 2 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  13. median percentage of time in hyperglycemia (>180mg/dl)after meal 3 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  14. median percentage of time in hyperglycemia (>180mg/dl) during intervention phase [ Time Frame: 4 weeks ]
    time in target/total time of records using continuous glucose monitoring)*100

  15. median percentage of time below 50mg/dl during control phase [ Time Frame: 4 weeks ]
    time in target/total time of records using continuous glucose monitoring)*100

  16. median percentage of time below 50mg/dl after meal 1 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  17. median percentage of time below 50mg/dl after meal 2 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  18. median percentage of time below 50mg/dl after meal 3 [ Time Frame: 180 minutes post meal ]
    time in target/180 mins * 100

  19. median percentage of time below 50mg/dl during intervention phase [ Time Frame: 4 weeks ]
    time in target/total time of records using continuous glucose monitoring)*100

  20. severe hypoglycemic events during control phase [ Time Frame: 4 weeks ]
    They will be measured as number of events per person during the weeks of Control Phase

  21. severe hypoglycemic events after meal 1 [ Time Frame: up to 24 hours ]
    They will be measured as number of events per person after meal 1 for the entire day

  22. severe hypoglycemic events after meal 2 [ Time Frame: up to 24 hours ]
    They will be measured as number of events per person after meal 2 for the entire day

  23. severe hypoglycemic events after meal 3 [ Time Frame: up to 24 hours ]
    They will be measured as number of events per person after meal 3 for the entire day

  24. severe hypoglycemic events during intervention phase [ Time Frame: 4 weeks ]
    They will be measured as number of events per person during the weeks of Intervention Phase.

  25. active hypoglycemia correction (carbohydrate intake) during control phase [ Time Frame: 4 weeks ]
    total number of active events per person during the weeks of Control Phase

  26. active hypoglycemia correction (carbohydrate intake) after meal 1 [ Time Frame: up to 24 hours ]
    total number of active events per person after meal 1 all day

  27. active hypoglycemia correction (carbohydrate intake) after meal 2 [ Time Frame: up to 24 hours ]
    total number of active events per person after meal 2 all day

  28. active hypoglycemia correction (carbohydrate intake) after meal 3 [ Time Frame: up to 23 hours ]
    total number of active events per person after meal 3 all day

  29. active hypoglycemia correction (carbohydrate intake) during intervention phase [ Time Frame: 4 weeks ]
    total number of active events per person during the weeks of Intervention Phase

  30. corrective bolus after meal during control phase [ Time Frame: 4 weeks ]
    total number of active events per person during the weeks of Control Phase vs Intervention Phase

  31. corrective bolus after meal 1 [ Time Frame: up to 24 hours ]
    total number of active events per person after meal 1 for the entire day

  32. corrective bolus after meal after meal 2 [ Time Frame: up to 24 hours ]
    total number of active events per person after meal 2 for the entire day

  33. corrective bolus after meal after meal 3 [ Time Frame: up to 24 hours ]
    total number of active events per person after meal 3 for the entire day

  34. corrective bolus after meal during intervention phase [ Time Frame: 4 weeks ]
    total number of active events per person during the weeks of Intervention Phase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034759


Locations
Layout table for location information
United States, Connecticut
Yale Pediatric Diabetes Research Program
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Study Chair: Eda Cengiz, MD Yale University

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03034759     History of Changes
Other Study ID Numbers: 1611018615
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
continuous glucose monitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs