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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
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The aim of this study is to assess the utility of CGMs to determine the optimal method to dose meal-time insulin. The investigators will examine glucose excursions in patients with CF who will dose meal-time rapid-acting insulin by carbohydrate counting versus fixed-dose rapid-acting insulin. The carbohydrate ratio and fixed doses will be determined by existing doses, total daily insulin doses, body weight, and insulin sensitivity along with predisposition to hypoglycemia. Bolus insulin dosing is an important part of CFRD management due to the high nutritional demands of these patients. If dosed incorrectly, this could lead to marked hyperglycemia and could worsen nutritional status due to urinary glucose losses. In this project, the investigators will perform a within-subjects' comparison of the 2 standard methods of meal-time rapid-acting insulin dosing.
Background and Introduction Cystic fibrosis-related diabetes (CFRD) is the most common extra-pulmonary comorbidity in patients with cystic fibrosis (CF). CFRD is also associated with an accelerated decline in pulmonary function, increased pulmonary exacerbations, and increased mortality. Continuous glucose monitoring (CGM) involves the use of a small disposable sensor sited in the subcutaneous interstitial fluid that makes frequent glucose measurements. There is data suggesting that the Medtronic iPro continuous glucose monitors (CGM) can predict hemoglobin a1c levels in patients with CFRD.
The aim of this study is to assess the utility of CGMs to determine the optimal method to dose meal-time insulin. The investigators will examine glucose excursions in patients with CF who will dose meal-time rapid-acting insulin by carbohydrate counting versus fixed-dose rapid-acting insulin. The carbohydrate ratio and fixed doses will be determined by existing doses, total daily insulin doses, body weight, and insulin sensitivity along with predisposition to hypoglycemia. Bolus insulin dosing is an important part of CFRD management due to the high nutritional demands of these patients. If dosed incorrectly, this could lead to marked hyperglycemia and could worsen nutritional status due to urinary glucose losses. In this project, the investigators will perform a within-subjects' comparison of the 2 standard methods of meal-time rapid-acting insulin dosing.
Hypothesis:
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Dosing, Followed by Carbohydrate Counting | Experimental | Dosing of premeal insulin with fixed doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Participants will be asked to dose insulin during the first week using fixed doses. During the second week of the study, participants will dose insulin based on carbohydrate counting. Blood sugar control will be compared between the 2 weeks to determine the outcomes of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Target | Measurement of percentage of time in target of glucose level | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | To determine the time spent in hypoglycemia as defined as blood sugar under 70 mg/dl | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jagdeesh Ullal, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology | Pittsburgh | Pennsylvania | 15213 | United States |
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Study subjects served as their own controls. There was no wash out or run-in period.
Study subjects were recruited from the Cystic Fibrosis Diabetes Clinic. The study was started on 9-15-2020 and concluded on 07-31-2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dosing, Followed by Carbohydrate Counting | Dosing of premeal insulin with fixed doses Insulin: Participants will be asked to dose insulin during the first week using fixed doses. During the second week of the study, participants will dose insulin based on carbohydrate counting. Blood sugar control will be compared between the 2 weeks to determine the outcomes of the study. Continuous glucose monitor (CGM): Participants will be required to wear a CGM to measure glucose trends |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fixed Insulin Dosing (7 Days) |
| |||||||||||||
| Carbohydrate Counting ( 7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Dosing, Followed by Carbohydrate Counting | Dosing of premeal insulin with fixed doses Insulin: Participants will be asked to dose insulin during the first week using fixed doses. During the second week of the study, participants will dose insulin based on carbohydrate counting. Blood sugar control will be compared between the 2 weeks to determine the outcomes of the study. Continuous glucose monitor (CGM): Participants will be required to wear a CGM to measure glucose trends |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in Target | Measurement of percentage of time in target of glucose level | Posted | Mean | Standard Deviation | percentage of time in range | 2 weeks |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fixed Dosing | Dosing of premeal insulin with fixed doses Insulin: Participants will be asked to dose insulin during the first week using fixed doses. Continuous glucose monitor (CGM): Participants will be required to wear a CGM to measure glucose trends |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor of Medicine | University of Pittsburgh Medical Center | 4125869700 | ullalj@upmc.edu |
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| 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 3, 2021 | Dec 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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This study design involves a within-subjects comparison using a sequential cross over that occurs over a 2-week time frame. During the first seven days of wear, the participants will be asked to dose their mealtime rapid-acting insulin by fixed-dose, and the next seven days, participants will be asked to dose their mealtime rapid-acting insulin by carbohydrate counting. After the 14 days, participants will return their continuous glucose monitor (CGM) devices for analysis and interpretation.
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|
| Continuous glucose monitor (CGM) | Device | Participants will be required to wear a CGM to measure glucose trends |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline weight | Mean | Standard Deviation | pounds |
|
| Participants |
|
|
|
| Secondary | Hypoglycemia | To determine the time spent in hypoglycemia as defined as blood sugar under 70 mg/dl | Posted | Mean | Standard Deviation | minutes | 2 weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Carb Counting | Dosing of premeal insulin with carb counting Insulin: During the second week of the study, participants will dose insulin based on carbohydrate counting. Continuous glucose monitor (CGM): Participants will be required to wear a CGM to measure glucose trends | 0 | 8 | 0 | 8 | 0 | 8 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |