Trial Outcomes & Findings for Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration (NCT NCT01698528)

Results Overview

The primary outcome of interest is absolute decrease in A1c by end of 3 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

3 months

Results posted on

2018-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.	Total n=40 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 16.04 • n=93 Participants	53.3 years STANDARD_DEVIATION 1.88 • n=4 Participants	53.52 years STANDARD_DEVIATION 13.76 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment United States	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

The primary outcome of interest is absolute decrease in A1c by end of 3 months.

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Glycemic Control as Determined by the Change in Absolute HbA1c Level	-3.16 Percent A1C Standard Deviation 1.54	-2.00 Percent A1C Standard Deviation 2.03

SECONDARY outcome

Timeframe: 3 months

Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Number of Participants Reaching Target of HbA1c ≤ 7%	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Change in Average Participation Satisfaction	10.1 Scores on a scale Standard Deviation 11.68	2.05 Scores on a scale Standard Deviation 6.45

SECONDARY outcome

Timeframe: 3 months

Number of participants had hypoglycemia during the trial period

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Number of Participants With Hypoglycemia	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes

Outcome measures

Outcome measures
Measure	Intervention Group n=20 Participants The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected. Tablet Computer	Control Group n=20 Participants The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration	108 min Standard Deviation 41	80 min Standard Deviation 51

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Dr William Hsu

Joslin Diabetes Center

Phone: 617-309-5803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place