Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days from the randomization |
| Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Viral Shah, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
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).
The data will be available after the publication. The data sharing details will be provided in the manuscript.
The committee (PI, statistician and Sponsor) will decide on appropriate request for data sharing.
Not provided
3 screen failed, 1 participant was lost to follow-up prior to screening, and 2 withdrew from study prior to randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| FG001 | Investigational Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No data is available for the two participants who did not have data collected due to COVID-19-related research disruption.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | percentage of time spent >180 mg/dL | 7 days from the randomization |
|
7 Days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE unrelated to the study | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Common cold |
Single Center study with small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Viral Shah, Principal Investigator | University of Colorado Anschutz Medical Campus | 303-724-8186 | viral.shah@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2020 | Apr 29, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CGM time below 70 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 | Frequency of SH and DKA between two groups | 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 | 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. | 7 days from the randomization |
| Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups | PRO between two groups | 7 days from the randomization |
| BG001 | Investigational Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Number of participants |
|
| Region of Enrollment | Number | participants |
|
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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | percentage of time spent in range | 7 days from the randomization |
|
|
|
| Secondary | Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups | CGM time below 70 between two groups | Posted | Median | Inter-Quartile Range | percentage of time below range | 7 days from the randomization |
|
|
|
| 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 | Frequency of SH and DKA between two groups | Posted | Count of Participants | Participants | 7 days from the randomization |
|
|
|
| Secondary | Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization | no of correction boluses between two groups | Posted | Median | Inter-Quartile Range | Boluses per day | 72 hours from the randomization |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 7 days from the randomization |
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups | PRO between two groups | Posted | Median | Inter-Quartile Range | Percent | 7 days from the randomization |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Investigational Transition | 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous | 0 | 13 | 0 | 13 | 2 | 13 |
|
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Percent overall work impairment |
|
| Percent activity impairment due to problem |
|