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| Name | Class |
|---|---|
| Mannkind Corporation | INDUSTRY |
| Tandem Diabetes Care, Inc. | INDUSTRY |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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This investigator-initiated study will enroll about 30 adults 18 to 65 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ or Control-IQ+ technology ("Control-IQ" which will refer to either Control-IQ or Control-IQ+). The study is being done to find out if inhaled insulin given for a meal is safer and better to use than a bolus of insulin through your pump when you exercise following a meal. Participants are asked to complete three study exercise visits in the clinic.
The study is a 3-period randomized crossover trial, each with a structured afternoon exercise session following a standard lunch meal. The 3 sessions are as follows: (1) TI for meal bolus with pump in sleep mode, (2) RAA for meal bolus with pump in sleep mode, and (3) RAA for meal bolus with pump in standard mode with transition to exercise mode one hour before start of exercise. The study is being done to compare the efficacy and safety of TI versus RAA given as bolus for meal prior to initiating aerobic exercise in adults ≥18 to ≤ 65 years of age with T1D using Control-IQ.
All participants will complete 3 exercise sessions, with the order determined through randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control IQ + sleep activity with TI | Experimental | TI for meal bolus with Control IQ + sleep activity pump setting |
|
| Control IQ + sleep activity with Rapid-Acting Analogue (RAA) Comparator | No Intervention | RAA for meal bolus with with Control IQ + sleep activity pump setting | |
| Control IQ + exercise activity with Rapid-acting analogue (RAA) Control | No Intervention | RAA for meal bolus with Control IQ pump setting with transition to Control IQ + exercise activity pump setting one hour before start of exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control IQ + sleep activity with TI | Device | TI for meal bolus with Control IQ + sleep activity pump setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose <70 mg/dL | Blood glucose <70 mg/dL within 90 minutes from the start of exercise | 90 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Efficacy Outcome: Change in blood glucose from exercise start to nadir glucose | Change in blood glucose from exercise start to nadir glucose within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: Change in CGM glucose from exercise start to nadir glucose |
Inclusion Criteria:
Exclusion Criteria:
Use of inhaled insulin within one week prior to screening visit
History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator
Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study
History or current diagnosis of lung cancer
Forced expiratory volume in 1 second (FEV1) measurement of <70% of predicted Global Lung Function Initiative value
Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
• A pregnancy test is required for any person of childbearing potential.
An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit
An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit
Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism
Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit
Exposure to any investigational drug in the 90 days prior to the screening visit
Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable)
Current use of Hydroxyurea medication
Current or anticipated use of a low carbohydrate diet (<50 grams/day) or low calorie diet (<800 kcal/day) during the time period of the study
Current treatment for diabetic retinopathy
Known stage 4/5 chronic kidney disease or on dialysis
Having a direct supervisor at place of employment who is directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin Gal, MSPH | Contact | 813-975-8690 | rgal@jaeb.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael R Rickels, MD, MA | University of Pennsylvania | Principal Investigator |
| Michael Ridell, PhD | York University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
A limited dataset is expected to be made available.
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Change in CGM glucose from exercise start to nadir glucose within 90 minutes from start of exercise |
| 90 minutes |
| Exploratory Efficacy Outcome: Time in range 70-180 mg/dL | Time in range 70-180 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: Time in tight range 70-140 mg/dL | Time in tight range 70-140 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: Mean glucose | Mean glucose within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: CGM glucose <54 mg/dL | CGM glucose <54 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: CGM glucose <70 mg/dL | CGM glucose <70 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: CGM glucose >250 mg/dL | CGM glucose >250 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Exploratory Efficacy Outcome: CGM glucose >300 mg/dL | CGM glucose >300 mg/dL within 90 minutes from start of exercise | 90 minutes |
| Safety Outcome: Severe hypoglycemia events | Defined as events requiring assistance of another person due to cognitive impairment to actively administer carbohydrate, glucagon, or other resuscitative actions | From enrollment to last clinic visit (up to ~12 weeks) |
| Safety Outcome: Blood glucose <54 mg/dL during clinic | Blood glucose <54 mg/dL between start of meal and discharge from clinic | 210 minutes |
| Safety Outcome: Blood glucose <70 mg/dL during clinic | Blood glucose <70 mg/dL between start of meal and discharge from clinic | 210 minutes |
| Safety Outcome: Adverse events related to exercise procedure | Adverse events related to the exercise procedure | From enrollment to last clinic visit (up to ~12 weeks) |
| Safety Outcome: Adverse events associated with technosphere insulin inhalation | Adverse events associated with technosphere insulin (TI) inhalation: hypersensitivity reaction, acute bronchospasm, treatment provided for asthma symptoms, or other symptoms associated with TI dosing | From enrollment to last clinic visit (up to ~12 weeks) |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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