Insulin Pump to Multiple Daily Injection Transition Clinical Trial

Phase 4

Completed

Conditions: Type 1 Diabetes

Interventions: Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Registration Number: NCT03987191

Lead Sponsor: University of Colorado, Denver

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.

Detailed Description: Second generation long acting insulin, insulin degludec, has been shown to improve glycemic control and reduce hypoglycemia in patients with type 1 diabetes and insulin treated type 2 diabetes. However, it takes about 48 hours before glycemic benefits are noticeable. Therefore, transition from insulin pump to multiple daily injection using insulin degludec is associated with hyperglycemia during first 48 hours of transition. Considering this, this study proposes to evaluate an investigational strategy to improve glycemic control during transition from insulin pump to multiple daily injections using insulin degludec and insulin aspart.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inverstigational Transition	Multiple daily ijnection using Insulin Degludec and Insulin Aspart	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
Standard of Care Transition	Multiple daily ijnection using Insulin Degludec and Insulin Aspart	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

Primary Outcome Measures

Name	Time	Method
Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups	7 days from the randomization	The primary outcome will be time spent in CGM glucose \>180 mg/dL (hyperglycemia) during 7days of randomization period between two groups.

Secondary Outcome Measures

Name	Time	Method
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups	7 days from the randomization	CGM time below 70 between two groups
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	Frequency of SH and DKA between two groups
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	CGM TIR between two groups
Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization	72 hours from the randomization	no of correction boluses between two groups
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups	7 days from the randomization	PRO between two groups
Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups	7 days from the randomization	PRO between two groups. The Insulin delivery satisfaction survey (IDSS) measures diabetes patients' satisfaction with their insulin delivery system. Possible scores range from 1-5, with higher scores indicating higher satisfaction and a better outcome.