Trial Outcomes & Findings for Family-Based Treatment for Type 1 Diabetes (NCT NCT05756361)

Last Updated: 2026-06-30

Results Overview

We will measure parent and child percent overweight at baseline, 3 months, and 6 months. Participants' weights and heights are taken during their respective visits, and BMIs are calculated and then compared to the BMI at the 50th percentile for the participants' age. Positive values indicate the participant's BMI percentage above the 50th percentile and negative values indicate the participant's BMI percentage below the 50th percentile

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline, 3 and 6 months

Results posted on

2026-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Children With T1D Child Arm -- pediatric participants with Type 1 Diabetes	Parents of Children With T1D Parent Arm -- adult parents of participating children with T1D
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family-Based Treatment for Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Child n=11 Participants Child Arm	Parent n=11 Participants Parent Arm	Total n=22 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 3 • n=20 Participants	45 years STANDARD_DEVIATION 5 • n=20 Participants	28.95 years STANDARD_DEVIATION 16.7 • n=40 Participants
Sex: Female, Male Female	9 Participants n=20 Participants	8 Participants n=20 Participants	17 Participants n=40 Participants
Sex: Female, Male Male	2 Participants n=20 Participants	3 Participants n=20 Participants	5 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=20 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=20 Participants	9 Participants n=20 Participants	18 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) White	10 Participants n=20 Participants	10 Participants n=20 Participants	20 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	11 Participants n=20 Participants	11 Participants n=20 Participants	22 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline, 3 and 6 months

Outcome measures

Outcome measures
Measure	Children With T1D n=11 Participants Child Arm -- pediatric participants with Type 1 Diabetes	Parent of Children With T1D n=11 Participants Parent Arm -- adult parents of participating children with T1D
Percentage Change in Participant BMI From 50th Percentile BMI Baseline	55.43 Percent change Standard Deviation 21.88	83.0 Percent change Standard Deviation 30.38
Percentage Change in Participant BMI From 50th Percentile BMI 3-Month	50.71 Percent change Standard Deviation 23.61	78.64 Percent change Standard Deviation 30.26
Percentage Change in Participant BMI From 50th Percentile BMI 6-Month	45.53 Percent change Standard Deviation 20.6	77.22 Percent change Standard Deviation 31.63

SECONDARY outcome

Timeframe: baseline, 3 and 6 months

Population: Children insulin only -- parents did not have diabetes

Metrics will be obtained through Insulin pumps, measured by units/kilogram/day

Outcome measures

Outcome measures
Measure	Children With T1D n=11 Participants Child Arm -- pediatric participants with Type 1 Diabetes	Parent of Children With T1D Parent Arm -- adult parents of participating children with T1D
Insulin Dosing Baseline	0.997212706 Units/Kg/Day Standard Deviation 0.196925042	—
Insulin Dosing 3-Month	0.971122734 Units/Kg/Day Standard Deviation 0.229036689	—
Insulin Dosing 6-Month	0.971062148 Units/Kg/Day Standard Deviation 0.196271018	—

SECONDARY outcome

Timeframe: baseline, 3 and 6 months

Population: Children HbA1c only -- parents did not have diabetes

Metrics will be obtained through Continuous Glucose Monitor

Outcome measures

Outcome measures
Measure	Children With T1D n=11 Participants Child Arm -- pediatric participants with Type 1 Diabetes	Parent of Children With T1D Parent Arm -- adult parents of participating children with T1D
HbA1c 3-Month	7.48 Percent Standard Deviation 0.57	—
HbA1c Baseline	7.69 Percent Standard Deviation 0.52	—
HbA1c 6-Month	7.4 Percent Standard Deviation 0.49	—

Adverse Events

Children With T1D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parents of Children With T1D

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

Teresa Quattrin

SUNY Buffalo

Phone: 716-323-0170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place