Trial Outcomes & Findings for Randomized Trial of Telemedicine for Diabetes Care (NCT NCT00271739)

NCT ID: NCT00271739

Last Updated: 2023-09-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1665 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2023-09-18

Participant Flow

Participant milestones

Measure	Telemedicine Case Management Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.	Usual Care Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
Overall Study STARTED	844	821
Overall Study COMPLETED	729	716
Overall Study NOT COMPLETED	115	105

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Telemedicine for Diabetes Care

Baseline characteristics by cohort

Measure	Telemedicine Case Management n=844 Participants Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.	Usual Care n=821 Participants Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.	Total n=1665 Participants Total of all reporting groups
Age, Continuous	70.8 years STANDARD_DEVIATION 6.5 • n=5 Participants	70.9 years STANDARD_DEVIATION 6.8 • n=7 Participants	70.8 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	536 Participants n=5 Participants	510 Participants n=7 Participants	1046 Participants n=5 Participants
Sex: Female, Male Male	308 Participants n=5 Participants	311 Participants n=7 Participants	619 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Telemedicine Case Management n=844 Participants Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.	Usual Care n=821 Participants Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
Hemoglobin A1c Levels	7.09 A1c percentage Standard Error 0.06	7.38 A1c percentage Standard Error 0.06

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Telemedicine Case Management n=844 Participants Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.	Usual Care n=821 Participants Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
Blood Pressure Levels	135.83 mmHg Standard Error 0.87	140.15 mmHg Standard Error 0.86

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Telemedicine Case Management n=844 Participants Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.	Usual Care n=821 Participants Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant's Primary Care Provider.
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol	91.13 mg/dL Standard Error 1.43	94.97 mg/dL Standard Error 1.40

Adverse Events

Telemedicine Case Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Walter Palmas, M.D.

Columbia University

Phone: 212-305-3163

Email: wp56@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place