Type 1 DiabetesPhase 4TRANSITIONNCT03987191
Insulin Pump to Multiple Daily Injection Transition Clinical Trial
A Phase 4 study testing Multiple daily ijnection using Insulin Degludec and Insulin Aspart in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Multiple daily ijnection using Insulin Degludec and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 8 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
About this study
Official title: Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Multiple daily ijnection using Insulin Degludec and Insulin Aspart
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple daily ijnection using Insulin Degludec and Insulin AspartDrug
Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
CGM TIR between two groups
Measured: 7 days from the randomization
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups
CGM time below 70 between two groups
Measured: 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
Frequency of SH and DKA between two groups
Measured: 7 days from the randomization
Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization
no of correction boluses between two groups
Measured: 72 hours from the randomization
Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups
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.
Measured: 7 days from the randomization
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups
PRO between two groups
Measured: 7 days from the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start10 Jan 2020
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viral Shah, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987191
- Sponsor's protocol ID
- 19-0924
- Acronym
- TRANSITION
- Status last verified
- Sep 2021
- First submitted
- 5 Jun 2019
- Last updated
- 13 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified academic researchers may request access to de-identified participant level data related to the study. The request letter with details such as reasons for data request, plan for data analysis, publication and so on should be emailed/mailed to the PI of the study (viral.shah@cuanschutz.edu).
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03987191
- Acronym / sponsor ID
- TRANSITION / 19-0924
- Conditions
- Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Transition | Active comparator | Drug: Multiple daily ijnection using Insulin Degludec and Insulin AspartStopping 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 |
| Inverstigational Transition | Experimental | Drug: Multiple daily ijnection using Insulin Degludec and Insulin AspartAdministration 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple daily ijnection using Insulin Degludec and Insulin AspartDrug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous | Drug | Inverstigational Transition, Standard of Care Transition |
Primary outcome
Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups
Time frame: 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.
6 secondary outcomes
Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups
Time frame: 7 days from the randomization
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups
Time frame: 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
Time frame: 7 days from the randomization
Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization
Time frame: 72 hours from the randomization
Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups
Time frame: 7 days from the randomization
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups
Time frame: 7 days from the randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified academic researchers may request access to de-identified participant level data related to the study. The request letter with details such as reasons for data request, plan for data analysis, publication and so on should be emailed/mailed to the PI of the study (viral.shah@cuanschutz.edu).
Related trials for Type 1 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viral Shah, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multiple daily ijnection using Insulin Degludec and Insulin Aspart in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups (time frame: 7 days from the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.