Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes

NCT04259775 | Withdrawn

• 2 other identifiers: 20000270022K12DK094714-06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Study results will be used to inform a larger RCT with an anticipated primary outcome of change in HbA1c in patients managed with either standard care (changes in therapy settings effected at regularly scheduled patients visits) or AIDA guided care.

Conditions

Type 1 Diabetes

Keywords

automated insulin dose adjustment; continuous glucose monitor

Outcome Measures

Primary Outcomes (2)

• Percent of patients at target range from baseline to 13 week

  Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL

  13 weeks

• Percent of patients at target range from baseline to 26 weeks

  Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL

  26 weeks

Secondary Outcomes (12)

• Change from baseline in HbA1c

  13 weeks

• Nighttime hypoglycemic defined as the % of time spent <55 mg/dL

  Baseline

• Nighttime hypoglycemic defined as the % of time spent <55 mg/dL

  13 week

• Nighttime hypoglycemic defined as the % of time spent <55 mg/dL

  26 week

• Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL

  Baseline

Study Arms (2)

Automated Insulin Dose Adjustment (AIDA)

ACTIVE COMPARATOR

Using the AIDA system to assist the parents of children with T1D make insulin dose adjustments

Device: Automated Insulin Dose Adjustment

Control

ACTIVE COMPARATOR

Standard Care - change in therapy settings effected a regularly scheduled patients visits

Device: Control

Interventions

Automated Insulin Dose Adjustment DEVICE

The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals. A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required. If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change. The patient or parent can accept or modify the recommended change. If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.

Automated Insulin Dose Adjustment (AIDA)

Control DEVICE

Standard Care - change in therapy settings effected at regularly scheduled patient visits

Control

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• i. Clinical diagnosis of type 1 diabetes for at least 1 year ii. Ages 7-21 years iii. Participants 18 years of age must be able to read and provide written consent iv. Participants under 18 years of age must be able to read and provide written assent v. Participants are managed using an insulin pump or multiple daily injections vi. Participant has a CGM or is willing to wear a CGM for the duration of the study

You may not qualify if:

• I. Hemoglobin A1c \<7.5% or \> 10.0% ii. Recent history of more than 1 episode of diabetic ketoacidosis (DKA) in the past 4 months iii. Treatment with glucose lowering drugs other than insulin iv. Females who are pregnant, lactating, or planning to become pregnant in the next 6 months v. Another medical condition that precludes participation in the study.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Nally, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share