The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is when used with different insulin delivery settings in the iLet™ in people with type 1 diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to 2 different insulin delivery settings for 7 days on each setting. The setting participants get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will have 4 visits and 1 phone contact with the study or staff.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements.
The bionic pancreas including pigtail adapters, used in insulin-only configuration
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage)
Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
Time frame: Day 1 to day 7
Time in Low Interstitial Glucose (Defined as Below 54 mg/dL [3 mmol/L]) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentage) - Median
Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
Time frame: Day 1 to day 7
Number of Treatment Emergent Severe Hypoglycaemic Episodes
Number of treatment emergent severe hypoglycaemic episodes from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.
Time frame: Day 1 to day 7
Number of Self-manageable (Able to Self-treat) Treatment Emergent Hypoglycaemic Episodes That Require Oral Carbohydrate Intervention Per Day
Mean number of self-manageable (able to self-treat) treatment emergent hypoglycaemic episodes that require oral carbohydrate intervention per day. Self-manageable (able to self-treat) hypoglycaemic episodes that require oral carbohydrate intervention per day is calculated as the sum of all hypoglycaemic episodes where the subject is able to self-treat and that require oral carbohydrate intervention divided by the actual duration of the treatment period in days. Treatment emergent is defined as an episode that has onset in the period from initiation of treatment to end of treatment.
Time frame: Day 1 to day 7
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Time frame: Day 1 to day 7
Number of Treatment Emergent Overall Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Overall hypoglycaemia count according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Time frame: Day 1 to day 7
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Time frame: Day 1 to day 7 (in both the treatment periods)
Number of Treatment Emergent Daytime Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Number of daytime hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Time frame: Day 1 to day 7
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition
ADA classification of hypoglycaemia: 1. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. 2. Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL). 3. Documented symptomatic hypoglycaemia: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL). 4. Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a measured PG concentration \> 3.9 mmol/L (70 mg/dL) but approaching that level. 5. Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG concentration ≤ 3.9 mmol/L (70 mg/dL).
Time frame: Day 1 to day 7
Number of Treatment Emergent Nocturnal Hypoglycaemic Episodes Classified According to the Novo Nordisk Classification
Number of nocturnal (from time 00:01-05:59 both inclusive) hypoglycaemic episodes according to Novo Nordisk classification. Novo Nordisk classification of hypoglycaemia: 1. Severe hypoglycaemia according to the ADA classification. 2. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia. 4. BG confirmed hypoglycaemia: The union of 2. and 3. 5. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2. 6. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
Time frame: Day 1 to day 7 (in both the treatment periods)
Time in Interstitial Glucose Range Was Defined as 70-180 mg/dL (3.9-10 mmol/L) From Initiation of Treatment (Day 1) to End of Treatment (Day 7) (Percentages)
Time in interstitial glucose range defined as 70-180 mg/dL (3.9-10 mmol/L) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in interstitial glucose range is calculated as the percentage of available interstitial glucose values above or equal to the low threshold and below or equal to the high threshold.
Time frame: Day 1 to day 7
Mean Interstitial-glucose Level
Mean interstitial glucose level is calculated as the average of the available interstitial glucose values.
Time frame: Day 1 to day 7
Number of Treatment Emergent Adverse Events
Number of treatment emergent adverse events from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.
Time frame: Day 1 to day 7
Number of Treatment Emergent Infusion Site Reactions
Number of treatment-emergent infusion site reactions from initiation of treatment (day 1) to end of treatment (day 7). Treatment emergent is defined as an event that has onset in the period from initiation of treatment to end of treatment.
Time frame: Day 1 to day 7
Total Insulin Dose Per Day
Total insulin dose (U/kg) per day from initiation of treatment (day 1) to end of treatment (day 7). Total daily insulin dose is calculated as the sum of all insulin doses delivered by the iLet™ divided by the actual duration of the treatment period in days.
Time frame: Day 1 to day 7
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