Phase 4
Completed N=32
Insulin Pump to Multiple Daily Injection Transition Clinical Trial
Source: ClinicalTrials.gov NCT03987191 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups — 46.3; 38.5 percentage of time spent >180 mg/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups |
46.3; 38.5 | — |
| SECONDARY Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups |
47.8; 56.5 | — |
| SECONDARY Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups |
3.9; 2.1 | — |
| SECONDARY 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 |
0; 0; 0; 0 | — |
| SECONDARY Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization |
6.5; 4.0 | — |
| SECONDARY Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups |
3.9; 3.9 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups |
0.0; 0.0; 0.2; 0.2; 1.0; 1.0 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03987191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.