Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial

Burnside, MJ; Lewis, DM; Crocket, HR; Meier, RA; Williman, JA; Sanders, OJ; Jefferies, CA; Faherty, AM; Paul, RG; Lever, CS; Price, SKJ; Frewen, CM; Jones, SD; Gunn, TC; Lampey, C; Wheeler, BJ; de Bock, MI

doi:10.1089/dia.2022.0484

Diabetes technology

Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial

Diabetes Technol TherPublished 28 Feb 2023Continuation phase of the CREATE randomised controlled trial

Primary result · TIR 3.9-10 mmol/L (70-180 mg/dL)ResultDifference 12.2 % 95% CI 10.4–14.1

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Authors' conclusion

Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.

Study context

Population: Children and adults (7–70 years) with T1D; Sensor-augmented pump therapy (SAPT) arm (SAPT-AID) crossed over to join open-source automated insulin delivery (AID) arm (AID-AID); most (69/94) used preproduction YpsoPump during continuation

Comparison: Open-source AID vs sensor-augmented pump therapy

Methodological detailscrossover of SAPT arm to AID, 24-week continuation phase

Crossover of SAPT arm to AID
24-week continuation phase

Primary result

Time in range (TIR) 3.9-10 mmol/L (70-180 mg/dL) · 52 weeks of data

Difference

12.2 %

95% CI 10.4–14.1

P < 0.001

By group

AID69.1%CI 67.1–71.1

SAPT56.9%CI 54.2–59.6

AIDvs SAPT

difference 12.2 % (95% CI 10.4–14.1); P < 0.001

As reported in the abstract

Treatment effect did not differ by age: P = 0.39
Treatment effect did not differ by insulin pump type: P = 0.37

Further findings

Outcome	Difference (mmol/mol) (95% CI)	P value
HbA1cLower with AID [0.5%]	5.1 (−6.6 to −3.6)	P < 0.001

Safety

DKA and severe hypoglycaemia · 48 weeks

Episodes of DKA or severe hypoglycemia with either treatment: 0

Withdrawals

Withdrew (all in SAPT-AID): 6
Hardware issues: 3
Preferred SAPT: 2
Infusion-site skin irritation: 1

Original publication

Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial. Diabetes Technol Ther. Published 28 February 2023. doi:10.1089/dia.2022.0484

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