Insulin Pump to Multiple Daily Injection Transition Clinical Trial

Completed · Phase 4

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT03987191

Run by

University of Colorado, Denver

People needed

38

Starts

2020-01-10

Expected to finish

2020-10-08

Last updated by the study team

2021-09-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• Known history of alcohol abuse or illicit drug use within 6 months prior to screening
• Use of investigational drugs within 5 half-lives prior to screening
• Participation to other study trials during the study period
• Elevated liver enzymes (AST and ALT) 3 times the upper limit of normal
• Hypoglycemia unawareness defined as GOLD score ≥4 [20]
• Any comorbidities or medical conditions that make a person unfit for the study at the discretion of the investigators
• Anticipated travel across different time zones (difference greater than 4 hours) or anticipated change in physical activities or diet at the discretion of the investigators.

Where it is running

• Barbara Davis Center for Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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