N/A
N=10
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
Type1diabetes · Hypoglycemia Unawareness · Nocturnal Hypoglycemia · Hypoglycemia Night · Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT03215914 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Endogenous Glucose Production — .66 [mg/(kgxmin)]
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MiniMed 670G system (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endogenous Glucose Production |
.69 | — |
| SECONDARY Endogenous Glucose Production |
.69 | — |
Summary
Can a type 1 diabetic adult avoid low glucoses and regain hypoglycemia awareness using a hybrid closed loop insulin delivery system? Involvement is 22 months (13 visits) and includes a 4-week Screening Phase and an 18-month Intervention Phase. Participants will undergo 3 Hyperinsulinemic Clamps done at: Baseline (before starting the device and after completing the screening), 6 months (after using the device 6 months), and after using the device for 18 months. This metabolic testing will allow us to measure improvement in hypoglycemia awareness.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 25 to 70 years.
- Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol.
- Clinical history compatible with type 1 diabetes with disease onset 10 years.
- Absent C-peptide ( 5% time spent in the hypoglycemic range (glucose 160 mmHg or diastolic blood pressure > 100 mmHg.
- Active cardiovascular disease
- Abnormal kidney function: eGFR 1.5 times the upper limit of normal.
- Untreated hypothyroidism, Addison's disease, or Celiac disease.
- Anemia: baseline hemoglobin concentration < 11 g/dl in women and < 12 g/dl in men.
- Presence of a seizure disorder not related to prior severe hypoglycemia.
- Use of glucocorticoids greater than 5 mg of prednisone daily, or an equivalent physiologic dose of hydrocortisone.
- For female participants of child-bearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of study participation. Oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
- Treatment with any anti-diabetic medication other than insulin within 4 weeks of enrollment.
- Use of any investigational agents within 4 weeks of enrollment.
- Any medical condition that, in the opinion of the PI, will interfere with the safe completion of the study
Data sourced from ClinicalTrials.gov (NCT03215914). 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.