NCT01324557

Brief Summary

The aims of this study are to assess the potential efficacy and safety of insulin pump to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.

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
44

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started Mar 2011

Typical duration for phase_2 diabetes

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

Study Start

First participant enrolled

March 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

March 9, 2011

Last Update Submit

March 28, 2011

Conditions

DiabetesPoor Glycemic Control

Keywords

Continuous glucose monitoringCAPD patientsInsulin pump

Outcome Measures

Primary Outcomes (1)

  • Glycosylated hemoglobin (HbA1c) measurement

    24 week follow-up

Secondary Outcomes (1)

  • The frequency of hypoglycemic episodes

    at 24 week follow-up

Study Arms (2)

CSII

EXPERIMENTAL

Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII)

Procedure: CSII and MDI

MDI

NO INTERVENTION

MDI: Control Optimized subcutaneous insulin by multiple daily injections (MDI)

Procedure: CSII and MDI

Interventions

CSII and MDIPROCEDURE

The aims of this study are to assess the potential efficacy and safety of insulin pump(MiniMed Paradigm® REAL-Time Revel™ Insulin Pump) to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic CAPD Patients.

CSIIMDI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 70 years old at registration
  • Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months
  • Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7

You may not qualify if:

  • Have peritonitis in recent 3 months other active bacterial infections
  • Unstable clinical conditions or evidence of malignancy
  • Pregnancy
  • Non-diabetic ESRD patients
  • Individuals already receiving diabetes therapy via an insulin pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shi Wei, PHD

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Shi Wei, PHD

CONTACT

8602083827812weishi_gz@126.com

Liu Shuangxin, PHD

CONTACT

86020837812mplsxi@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

CN(1)