Abstract | BACKGROUND: RESEARCH DESIGN AND METHODS: This pilot, investigator-led, collaborative, open-label, multicenter, clinical research trial enrolled 60 patients with T1DM with HbA1c levels ≥6.5% and ≤10%. Individuals were randomized to treatment with titrated TI (n = 26) or titrated insulin aspart (n = 34), stratified by baseline HbA1c levels (≤8% or >8%). All were required to wear a real-time CGM throughout the trial. All patients in the TI group were advised to take supplemental inhalations at 1 and 2 h after meals if indicated based on postprandial glucose (PPG) values. The coprimary outcomes were assessed both in the full intent-to-treat population and in those individuals randomized to TI who were compliant with supplemental doses ≥90% of the time (n = 15). The CGM data were analyzed using linear regression models. RESULTS: Overall, those treated with TI versus aspart achieved comparable TIR, but less time spent in hypoglycemia (<60 and <50 mg/dL, both P < 0.05). In the TI-compliant group (n = 15), TIR was significantly greater (62.5% ± 2.6% vs. 53.8% ± 1.7%, P = 0.009) and time in hyperglycemia >180 mg/dL was lower (34.2% ± 2.7% vs. 41.0% ± 1.7%, P = 0.045) as compared with the aspart group. PPG was also significantly lower in the TI cohort at 60 and 90 min postmeal, and PPGE were lower in the TI-compliant group as compared with the aspart group over 1-4-h postmeal (P < 0.05). In addition, there was weight gain in the aspart group compared with weight loss in the TI group (P = 0.006) despite higher prandial TI insulin dose. CONCLUSIONS: We conclude that using TI appropriately at mealtimes with supplemental dosing improves prandial glucose (TIR and 1-4 h) control without any increase in time in hypoglycemia or weight gain in patients with T1DM on MDI. The study results support a larger study using a treat-to-target design to confirm these findings. Clinical trial reg. no. NCT03143816, clinicaltrials.gov .
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Authors | Halis Kaan Akturk, Janet K Snell-Bergeon, Amanda Rewers, Leslie J Klaff, Bruce W Bode, Anne L Peters, Timothy S Bailey, Satish K Garg |
Journal | Diabetes technology & therapeutics
(Diabetes Technol Ther)
Vol. 20
Issue 10
Pg. 639-647
(10 2018)
ISSN: 1557-8593 [Electronic] United States |
PMID | 30207748
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin Aspart
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Topics |
- Administration, Inhalation
- Adult
- Blood Glucose
(analysis)
- Blood Glucose Self-Monitoring
- Diabetes Mellitus, Type 1
(drug therapy)
- Drug Delivery Systems
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hyperglycemia
(blood, drug therapy)
- Hypoglycemic Agents
(administration & dosage, therapeutic use)
- Injections
- Insulin
(administration & dosage, therapeutic use)
- Insulin Aspart
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Pilot Projects
- Treatment Outcome
- Weight Gain
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