Insulin Pump to Multiple Daily Injection Transition Clinical Trial

NCT03987191 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-0924
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled, two arms, investigator initiated, intervention study is aimed to examine an investigational approach in contrast to the clinical standard of 1:1 dose basal insulin conversion in an attempt to lower the incidence and/or duration of hyperglycemia after transition from insulin pump to multiple daily injections in adults with type 1 diabetes.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups

  The primary outcome will be time spent in CGM glucose \>180 mg/dL (hyperglycemia) during 7days of randomization period between two groups.

  7 days from the randomization

Secondary Outcomes (6)

• Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups

  7 days from the randomization

• Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups

  7 days from the randomization

• Number of Participants With Severe Hypoglycemia as Defined by the ADA (Severe Cognitive Impairment Requiring External Assistance for Recovery) and Severe Hyperglycemia (BG≥250 Needing Hospitalization) Between Two Groups

  7 days from the randomization

• Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization

  72 hours from the randomization

• Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups

  7 days from the randomization

Study Arms (2)

Standard of Care Transition

ACTIVE COMPARATOR

Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections

Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Inverstigational Transition

EXPERIMENTAL

Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition

Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Interventions

Multiple daily ijnection using Insulin Degludec and Insulin Aspart DRUG

Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Inverstigational Transition; Standard of Care Transition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤ 65 years
• Patients with T1D diagnosed for at least 12 months
• Point-of-care HbA1c levels between ≥6.5% and ≤ 8.5%
• Patients on CSII (any insulin pump) for at least past 6 months
• Willing and able to wear a blinded CGM during the time of study period
• Willing to perform self-monitoring of blood glucose (SMBG) at least 4 times a day
• Ability to provide informed consent before any trial-related activities
• Not willing to or plan any travel out of Colorado during the 3 weeks of study period
• Willing to use insulin degludec in the morning once a day

You may not qualify if:

• Age \<18 years and \> 65years
• HbA1c \>8.5 % at screening
• Less than 12 months of insulin treatment
• Patients on 670G or Tandem Control IQ (Medtronic and Tandem Hybrid Closed-loop systems) and not willing use manual mode during the study period
• Patients with T1D using any glucose lowering medications other than insulin
• Pregnancy, breast feeding, and positive pregnancy test during screening
• Women of childbearing age wanting to become pregnant or not using adequate contraceptive measures
• Current or recent (\< 2 weeks prior to visit 1) use of any steroidal medication, or anticipated steroidal treatment, during the study period
• eGFR below 45 ml/min/1.73 m\^2 using MDRD formula
• History of severe hypoglycemia in the previous 3 months
• History of diabetic ketoacidosis (DKA) requiring hospitalization in the past 3 months
• History of allergy to any form of insulin or its excipients
• History of allergy to adhesives
• Unwilling to use blinded CGM during the study period
• Unwilling to perform SMPG at least 4 times a day

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Single Center study with small sample size

Results Point of Contact

• Title: Dr. Viral Shah, Principal Investigator
• Organization: University of Colorado Anschutz Medical Campus

viral.shah@cuanschutz.edu

303-724-8186

Study Officials

• Viral Shah, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 14, 2019
• Study Start: January 10, 2020
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: September 13, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the publication. The data sharing details will be provided in the manuscript.
• Access Criteria: The committee (PI, statistician and Sponsor) will decide on appropriate request for data sharing.

Locations

US (1)