N/A
N=20
Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03804983 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Percent Time in Range at Home Pre/Post Intervention at Home — 77.8; 70.7; 68.9; 70.1 percentage of time spent in range — p=0.178
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hybrid Closed Loop (HCL) (Device); Control-IQ with MyTDI (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Time in Range at Home Pre/Post Intervention at Home |
77.8; 70.7; 68.9; 70.1 | 0.178 |
| SECONDARY Average CGM at Home |
142.4; 152.2; 156.5; 152.9 | 0.145 |
| SECONDARY Average CGM at Camp |
142.4; 152.2; 144.3; 141.3 | 0.304 |
| SECONDARY Percentage of CGM Values Below 50mg/dL at Home |
0.0; 0.0; 0.0; 0.6 | 0.131 |
| SECONDARY Percentage of CGM Values Below 50mg/dL at Camp |
0.0; 0.0; 0.3; 0.16 | — |
| SECONDARY Percentage of CGM Values Below 54mg/dL at Camp |
0.1; 0.1; 0.0; 0.0 | 0.206 |
| SECONDARY Percentage of CGM Values Below 60mg/dL at Home |
0.7; 0.7; 0.5; 1.3 | 0.335 |
| SECONDARY Percentage of CGM Values Below 60mg/dL at Camp |
0.7; 0.7; 0.5; 0.9 | 0.637 |
| SECONDARY Percentage of CGM Values Below 70mg/dL at Home |
1.9; 2.1; 0.9; 2.4 | 0.347 |
| SECONDARY Percentage of CGM Values Below 70mg/dL at Camp |
1.9; 2.1; 1.4; 3.8 | 0.057 |
| SECONDARY Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp |
77.8; 70.7; 78.4; 76.5 | 0.435 |
| SECONDARY Percentage of CGM Values Above 180mg/dL at Home |
18.9; 26.9; 29.1; 27.2 | 0.135 |
| SECONDARY Percentage of CGM Values Above 180mg/dL at Camp |
18.9; 26.9; 20.1; 20.1 | 0.271 |
| SECONDARY Percentage of CGM Values Above 250mg/dL at Home |
3.4; 6.5; 5.8; 3.8 | 1.0 |
| SECONDARY Percentage of CGM Values Above 250mg/dL at Camp |
16; 10; 14.88; 8.04 | — |
| SECONDARY Percentage of CGM Values Above 300mg/dL at Home |
0.3; 0.3; 0.7; 0.9 | 1.0 |
| SECONDARY Percentage of CGM Values Above 300mg/dL at Camp |
0.3; 0.3; 0.0; 0.0 | 0.294 |
| SECONDARY Change in Total Daily Insulin at Home |
39.0; 48.7; 48.2; 54.9 | 0.584 |
| SECONDARY Change in Total Daily Insulin at Camp |
39.0; 48.7; 38.8; 50.9 | 0.69 |
| SECONDARY Change in Total Meal Carbohydrates at Home |
226.3; 204.1; 276.5; 192.6 | 0.066 |
| SECONDARY Change in Total Meal Carbohydrates at Camp |
226.3; 204.1; 280.0; 254.6 | 0.904 |
| SECONDARY Change in Number of Hypoglycemic Events at Camp |
1; 0.5; 1; 1 | — |
| SECONDARY Number of Hypoglycemia Treatment at Camp |
1.5; 2.5 | — |
| SECONDARY Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp |
35.9; 43.6 | — |
| SECONDARY Change in Hypoglycemia Events at Home |
1; 0.6; 0.3; 0.7 | — |
Summary
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
Eligibility Criteria
Inclusion Criteria
- Criteria for documented hyperglycemia (at least 1 must be met):
- Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
- Diagnosis of type 1 diabetes is based on the investigator's judgement
- Criteria for requiring insulin at diagnosis (both criteria must be met):
- Daily insulin therapy for ≥ 6 months
- Insulin pump therapy for ≥ 3 months
- Age 12-18 years
- Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
- Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
- For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
- Total daily insulin dose (TDD) at least 10 U/day.
Exclusion Criteria
- Diabetic ketoacidosis in the past 6 months
- Hypoglycemic seizure or loss of consciousness in the past 6 months
- History of seizure disorder
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- History of altitude sickness
- Chronic pulmonary conditions that could impair oxygenation
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
- Pregnancy
- Presence of a febrile illness within 24 hours of the Ski Admission
- Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse
Data sourced from ClinicalTrials.gov (NCT03804983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.