NCT04949022

Brief Summary

The purpose of this study is to evaluate the effectiveness of advanced hybrid-closed loop system, Minimed 780G to glycemic control and safety in children aged 2-6 years with type 1 diabetes. Additionally, the study evaluates the perceived burden of the diabetes treatment to families during the advanced hybrid-closed loop system treatment (diabetes distress). This is a prospective, non-randomized, single-arm study, where primary endpoint is the change in TIR after hybrid-closed loop system initiation. Secondary endpoints are safety (number of severe hypoglycaemias and diabetic ketoacidosis, DKA), HbA1c, time below range (TBR), mean sensor glucose (SG), standard deviation of SG, and coefficient of variation (CV). The inclusion criteria are 1) TDD (total insulin daily dose) ≥ 8 units, 2) HbA1c \< 10%, 3) capability to use pump and the CGM, and 4) time from diabetes diagnosis more than 6 months. The exclusion criteria are hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

June 17, 2021

Last Update Submit

January 10, 2022

Conditions

Type 1 Diabetes

Keywords

hybrid closed loop system

Outcome Measures

Primary Outcomes (2)

  • Time in range (glucose between 3.9-10 mmol/l) before and during hybrid close loop insulin pump treatment

    Time in range (%) derived from continuous glucose monitoring

    Up to 3 months

  • Time in range (glucose between 3.9-10 mmol/l) before and during hybrid close loop insulin pump treatment

    Time in range (%) derived from continuous glucose monitoring

    Up to 12 months

Secondary Outcomes (8)

  • The number of severe hypoglycemia before and during hybrid close loop insulin pump treatment

    Up to 3 months

  • The number of severe hypoglycemia before and during hybrid close loop insulin pump treatment

    Up to 12 months

  • Number of diabetic ketoacidosis in participant before and during hybrid close loop insulin pump treatment

    Up to 3 months

  • Number of diabetic ketoacidosis in participant before and during hybrid close loop insulin pump treatment

    Up to 12 months

  • Diabetes distress before and during hybrid close loop insulin pump treatment

    Up to 3 months

  • +3 more secondary outcomes

Other Outcomes (8)

  • Time below range (glucose <3.9mmol/l) before and during hybrid close loop insulin pump

    Up to 3 months

  • Time below range (glucose <3.9mmol/l) before and during hybrid close loop insulin pump

    Up to 12 months

  • Mean sensor glucose before and during hybrid close loop insulin pump

    Up to 3 months

  • +5 more other outcomes

Study Arms (1)

Hybrid closed loop system

EXPERIMENTAL

Initiation of 780G insulin pump. First two weeks run-in-phase in open loop Manual mode, followed by a12 month study phase with advanced hybrid closed loop Auto mode.

Device: Medronic 780G insulin pump

Interventions

Medronic 780G insulin pumpDEVICE

Commercial hybrid closed loop system Medronic 780G

Hybrid closed loop system

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • total insulin daily dose ≥ 8 units
  • HbA1c \< 10%
  • capability to use pump and the CGM
  • time from diabetes diagnosis more than 6 months

You may not qualify if:

  • hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital, New Children's Hospital and Jorvi Hospital

Helsinki, Finland

RECRUITING

Related Publications (5)

  • Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.

    PMID: 25998289BACKGROUND

  • Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Chernavvsky D, Wadwa RP; iDCL Trial Research Group. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736.

    PMID: 32846062BACKGROUND

  • Lind M, Pivodic A, Svensson AM, Olafsdottir AF, Wedel H, Ludvigsson J. HbA1c level as a risk factor for retinopathy and nephropathy in children and adults with type 1 diabetes: Swedish population based cohort study. BMJ. 2019 Aug 28;366:l4894. doi: 10.1136/bmj.l4894.

    PMID: 31462492BACKGROUND

  • Hagger V, Hendrieckx C, Sturt J, Skinner TC, Speight J. Diabetes Distress Among Adolescents with Type 1 Diabetes: a Systematic Review. Curr Diab Rep. 2016 Jan;16(1):9. doi: 10.1007/s11892-015-0694-2.

    PMID: 26748793BACKGROUND

  • Pulkkinen MA, Varimo TJ, Hakonen ET, Harsunen MH, Hyvonen ME, Janer JN, Kiiveri SM, Laakkonen HM, Laakso SM, Wehkalampi K, Hero MT, Miettinen PJ, Tuomaala AK. MiniMed 780G in 2- to 6-Year-Old Children: Safety and Clinical Outcomes After the First 12 Weeks. Diabetes Technol Ther. 2023 Feb;25(2):100-107. doi: 10.1089/dia.2022.0313. Epub 2022 Dec 30.

    PMID: 36511831DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anna-Kaisa Tuomaala, MD, PhD

    Helsinki University Hospital, New Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna-Kaisa Tuomaala, MD, PhD

CONTACT

+358505430180anna-kaisa.tuomaala@hus.fi

Tero Varimo, MD, PhD

CONTACT

+358504279569tero.varimo@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, fellow in pediatric endocrinology, principal investigator

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 2, 2021

Study Start

August 23, 2021

Primary Completion

October 1, 2022

Study Completion

December 31, 2023

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
24 months after the completion of the study
Access Criteria
Data will be shared according to the EU General Data Protection Regulation and national and hospital data protection regulations.

Locations

FI(1)